Related review hundred questions (1)
Accessories are produced by the United States，Never registered in the country，How to operate? What materials are submitted?
Answer: According to the "Announcement of the General Administration on the Approval of Pharmaceutical Pharmaceutical Supplementary Materials and Pharmaceutical Review and Approval" (hereinafter referred to as "Announcement") (No. 134, 2016)，Pharmaceutical packaging materials when applying for drug registration、Pharmaceutical Accessories Implementation of Review Approval。That is to say，The State Administration of General Administration will no longer accept the application of medicinal auxiliary materials alone，Only drugs using this pharmaceutical auxiliary material for registration and declaration，A review and approval of the pharmaceutical auxiliary materials scope of the affiliated review specified in the "Announcement"，Medicinal accessories for domestic listing or unlisted preparations，Not obtained the approved certificate or approved number，It shall be in accordance with Article 3 of the "Announcement"，For medicinal auxiliary materials that meet the application requirements，Fill in the information in accordance with the "Pharmaceutical Pharmaceutical and Medicinal Accessories Reporting Data Requirements" issued by the General Administration，and press "Announcement" Chinese Medicine Pack Material、Pharmaceuticals and drug association review approval procedures (trial) to declare。After the application of drug production is approved，The medicinal auxiliary materials declared by the association no longer issue a approval article，Instead, the approved number is given by the Pharmaceutical Examination Center of the General Administration。
During the transition period of the review and approval of the affiliate review，New drug preparations when applying，Pharmacles and medicinal auxiliary materials that have obtained the registration certificate，If all materials are prepared in accordance with DMF data，Can you give priority review?
Answer: In the current implementation of pharmaceutical packaging materials and drug association review and approval management system，It has not stipulated that the relevant management requirements for DMF data filing for pharmaceutical auxiliary materials，Therefore, the current national drug regulatory agency does not accept the DMF declaration information of the medicinal auxiliary materials alone。"Announcement" has been officially released by the State Administration of General Administration on August 10, 2016。"Announcement" is implemented，Medicinal Accessories used for drugs that have been listed currently available，If the approval number has been obtained，When used in other similar preparations，If the pharmaceutical auxiliary materials scope of the joint review of the joint audit in the "Announcement"，Especially the high -risk preparation accessories and the medicinal auxiliary materials that are specially required by the State Administration of General Administration as needed，still need to be reached by related review;，There is no need to conduct association review。(The experts in this issue are Hong Xiaoxu, deputy director of the Business Comprehensive Division of the National Pharmacopoeia Commission)
Related review 100 questions (2)
Registered drugs replaced pharmaceutical bag materials (supplier)、How to declare the selection of drugs (suppliers)? How to review it?
Answer: The General Administration of the General Administration of Pharmaceutical Medical Accessories and Pharmaceutical Review and Approval Course (Article 5, No. 134, 2016)，Clarified the drug clinical trial application or production application for drugs，The information should be submitted in accordance with the requirements of the announcement。Drug changes (replaced or added alternative) pharmaceutical bag，According to the requirements of the administrative measures of drug registration，Application for supplementary drugs should be submitted，and whether the application for application is applicable to the scope of the related review announcement，To be officially interpreted。Specific change declaration requirements，For reference、Class II and Class III changes to carry out research and verification work，and the classification of high -risk pharmaceutical packaging materials and non -high -risk pharmaceutical packaging materials in Annex 1，Comprehensive consideration of the risk level and classification requirements of the enterprise changing pharmaceutical packaging materials。Overall，The packaging materials and containers of changing drugs should be able to play a beneficial effect on ensuring product quality and stability，or at least not reduce its protection function，Drugs and packaging materials and containers must not have adverse interaction。
The original imported bag material was after the import registration certificate expired，What file support is supported by the original user? Can the packaging material production enterprise be filing and declaration?
Answer: The validity period of the imported bag registration certificate described in this question has expired，You can refer to the provisions of the General Administration on Article 5 of the General Administration of Pharmaceutical Medical Accessories and Drug Review Approval (Article 5, 2016)。Pharmaceutical bag registration certificate expired before December 31, 2017，The validity period continues to December 31, 2017。After December 31, 2017，You can also continue to use in the original medicine。If the original medicine submits its drug to the continuation of the drug before December 31, 2017，Pharmaceutical packaging certificates for the expiry date can be used as proof documents; if the original drugs submit their drugs after December 31, 2017，According to the announcement, you can continue to use this pill，However, there is no proof file for the package material available。It is recommended that pharmaceutical bag material manufacturers transition to the December 31, 2017 given by the announcement，Considering the related review information of the packaging variety that expires the validity period。(This issue is answered by experts from the China Pharmaceutical Packaging Association)
Related review hundred questions (3)
How to maintain the consistency of pharmaceutical packaging materials and drug associations?
According to the "Announcement" and "Related Review Procedures", when the pharmacrarine material is reported in the clinical test or production application of the pharmaceutical bag，Pharmaceutical packaging material manufacture、Drug name and acceptance number and other information Fill in the "Pharmaceutical Bag Material Declaration Form"，and submit the declaration information truthfully to the provincial food and drug supervision and management department of the local area。and the applicant for the pharmaceutical registration when submitting a drug registration application，In the "Pharmaceutical Pharmaceutical Source" project in the drug registration application form, the relevant information of all related pharmaceutical bag materials should。From the perspective of procedures and time，It must be a pharmaceutical registration applicant to submit the application first，After obtaining the acceptance number, the pharmaceutical packaging material manufacturer submits the information with this acceptance number。Because the information is submitted separately，and may be submitted in different provincial bureaus，The potential impact brought by is that drug registration applicants will be more worried about whether the time and quality of the materials submitted by the original auxiliary material supplier will affect the application of drug registration，Therefore, it will be more inclined to choose more credit、Pharmacular bag material manufacturers with better service quality and better product quality，and may involve the requirements of the time limit and quality of the information in the agreement between the two parties。From technical requirements，Follow -up will announce the specific "Requirement Information Requirements"，Drug registration applicants will choose pharmaceutical bag materials according to the requirements of the level of risk level，At the same time, the pharmaceutical packaging material enterprise submits relevant information and information in accordance with regulations。
In addition，information involved (including drugs、Pharmaceutical bag、raw and auxiliary materials, etc.) Only after the drug review center is summarized，and the specific review procedures within the current drug review center have not been made public，So the specific circulation of the application information、Information transmission, etc.，Not clear。
When the pharmaceutical bag production enterprise is changed, the pharmacraislaxes are changed，Interesting to conceal the change，Until the quality of the medicine, it can be discovered，Is there a good way to solve this problem?
The Announcement clearly stipulates the responsibility and obligation of pharmaceutical packaging materials and drug registration applicants，is the pharmaceutical bag material、Change the prescription of medicinal auxiliary materials、Craft、Quality Standard and other changes that affect the quality of the product，stake betting appIts production enterprises should actively carry out corresponding evaluations，Timely notify the drug production enterprise，and submit relevant information to the food and drug supervision and management department as required。Drug registration applicants shall ensure that the drug bags they use meet the medicinal requirements，and timely grasp the changes in the pills，and study and evaluate the impact caused by the change，In accordance with the relevant provisions of the "Administrative Measures for Drug Registration", submit a corresponding supplementary application to the food and drug supervision and management department。In order to avoid affecting the quality of drugs due to supplier problems，On the one hand, pharmaceutical manufacturers will be more inclined to choose more credit、Pharmaceutical packaging material production enterprises with better service quality and better product quality; on the one hand, it will establish a mechanism in terms of information communication between the two parties，Make sure to get changing information in time;，It will put forward the requirements for changes in pharmaceutical packaging materials in the agreement between the two parties。(This issue of answers is Han Peng, deputy dean and academic director of Shenyang Pharmaceutical University Yimong Business College)
Related review hundred questions (4)
What standards do the production management of pharmaceutical packaging materials are used to regulate and regulate，Is there a specific guide?
Pharmaceutical bag material production enterprises daily production standard management is to ensure the quality of pharmaceutical packaging materials、The fundamental guarantee of stability and reliability。Pharmaceutical bag、The implementation of the review and approval system for medicinal auxiliary materials and drug associations will further strengthen the main responsibility of drug production enterprises。Drug production enterprises should strengthen audit of pharmaceutical packaging suppliers，Control the product quality through the entire production process，Reduce potential risk。Current，my country's drug management department has not yet issued technical requirements for the production management specifications of compulsory pharmaceutical packaging materials (GMP)。Current，Selection and quality of pharmaceutical packaging materials "re -test、Light management; heavy result、Light Process "，To a certain extent, the impact of the production process of pharmaceutical packaging materials on product quality。There are many categories of pharmaceutical bags used by medicines、Different raw materials、The difference in production methods is large、Pharmaceutical bag production management specifications that are completely unified mode are difficult to meet the needs of different types of pharmaceutical packaging materials，So，The corresponding production management specifications should be formulated for different categories of pharmaceutical bag materials，For example, formula for glass、GMP requirements of rubber -class。Stable advancement、Principles of Graduation，Current，The National Pharmacopoeia Commission has already started to consider guiding related industry associations，Formulate GMP requirements for different categories of pharmaceutical packaging materials。initial，It will be released in the way of GMP industry technical guide，Production as a pharmaceutical bag material production enterprise、Daily audit of preparation companies。After a period of implementation and complement，After the technical requirements are mature，The technical requirements of the drug packaging material GMP can be released through the official release or recognition method，As a technical requirements for compulsory implementation。
If the pharmaceutical company is registered with the pharmaceutical packaging materials and medicinal auxiliary materials, the registration certificate expires，Pharmaceutical packaging materials and medicinal auxiliary materials companies want to submit related review materials?
According to the "Announcement of the General Administration on the Approval of Pharmaceutical Medical Accessories and Drug Review Approval" (hereinafter referred to as "Announcement"): "Approved Pharmaceutical Bag Materials、Medicinal Accessories，The approved certification file continues to be valid during the validity period。After the expiry of the validity period，can continue to be used in the original medicine。When clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement "。That is to say，After the validity period of the certification document of the pharmacraislavia material，No re -registration or submission of related reporting materials will be registered or submitted by December 31, 2017，Can still be used in the preparation agent。until January 1, 2018，If it is used for registration and declaration for other drugs，Related information needs to be submitted。(The experts in this issue are Hong Xiaoxu, deputy director of the Business Comprehensive Division of the National Pharmacopoeia Commission)
Related review hundred questions (5)
Change the prescription of the pharmaceutical bag、Craft、Quality Standards、Source of raw materials, such as changes that affect product quality,How to apply for a pharmaceutical company using this pharmaceutical bag? How to review it?
According to the announcement，Food and drug supervision and management departments at all levels will no longer accept pharmaceutical packaging materials alone、Registration application for medicinal auxiliary materials，No longer issuing relevant registration approval documents。The changes in the current medicinal accessories and pharmaceutical bags are not clear，Follow -up will also formulate changes in the guidance of pharmaceutical accessories and pharmaceutical packaging materials。If it affects the original preparation product，15761_15783。
Pharmaceutical packaging materials production new products，Do you have to apply for the association when registering a new drug through a pharmaceutical company to record and get the filing number?
According to the announcement，New Auxiliary materials or new bag，All need to be used in accordance with the principle of "reimbursement"，Correlation declaration with preparation products，Submit the application information for the acceptance number of the product products。Therefore, early development of preparation products needs to be participated early。
The original imported bag material was after the import registration certificate expired，Which file does the original user support it to continue using it? Is the packaging manufacturer's information filing and declaration?
According to the announcement，The certified accessories are no longer registered，The validity period is postponed to December 31, 2017，and use it in the original preparation products without any affected; after January 1, 2018，If it is used in other preparation products，You need。(This issue of answers is Han Peng, deputy dean and academic director of Shenyang Pharmaceutical University Yimong Business College)
Related review hundred questions (6)
Biological product preparations that have been accepted and existing clinical approval，Using a registered certificate without a registered certificate，Do you need to be associated with review when reporting?
According to the announcement of the General Administration of Pharmaceutical Medical Accessories and Drug Review Approval, Article 3，From the date of the announcement of this announcement，Pharmaceutical bag、The medicinal auxiliary materials shall be approved by the procedure and the drug registration application and review approval，"Requirements for the Requirements for the Application of Pharmaceutical Pharmaceuticals and Medicinal Accessories" will be announced separately。Food and drug supervision and management departments at all levels will no longer accept pharmaceutical packaging materials alone、Registration application for medicinal auxiliary materials，No longer issuing relevant registration approval documents。Biological product companies use unregistered accessible materials in new products，Related review must be conducted in accordance with regulations，Submit review information。
Re -registered medicine after January 1, 2018，The original drug bag material still used、Auxiliary materials do not involve requiring changes，Do you need to be associated with review?
According to the General Administration of the General Administration of Pharmaceutical Medical Accessories and Drug Review Approval, Article 5，Approved Pharmaceutical Bag Material、Medicinal Accessories，The approved certification file continues to be valid during the validity period。After the expiry of the validity period，can continue to be used in the original medicine。When clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Approve the certification documents that expires before December 31, 2017 (including the day)、Medicinal Accessories，The validity period continues to December 31, 2017。From January 1, 2018，Drug clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Other medicinal auxiliary materials used in the history of drugs in the marketing drugs，can continue to be used in the original medicine。But when applying or production application for drug clinical trials for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Still use the original drug bag material、The auxiliary materials do not involve the request when the change，Supplementary filing information，Get the new preparation number。(This issue of answering experts is Tu Jiasheng, a professor at the University of Pharmacy)
Related review hundred questions (7)
New customers buy old preparations，What should I do if there is no registration certificate for pharmaceutical bag materials? During the review of drug production enterprises，Is it your own application materials or the same variety data declared by other pharmaceutical companies in other pharmaceutical companies?
Announcement of the State Food and Drug Administration on the announcement of the review and approval of pharmaceutical packaging materials and drug associations and drug associations.，Approved Pharmaceutical Bag Material、Medicinal Accessories，The approved certification file continues to be valid during the validity period。After the expiry of the validity period，can continue to be used in the original medicine。When clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。Including related research materials and the need for supplementary pharmaceutical bag materials。
New customers purchase preparations，Pharmaceutical bags used in the preparation have no registration certificate，The related regulations shall be re -carried out in accordance with relevant regulations。In the related review review, you can use the data declared by the filing materials stake betting app(the authorized letter of the pharmaceutical packaging material enterprise and complies with relevant regulations)，After review, if you need to replenish materials, you need to supplement。
Pharmaceutical packaging materials need to communicate with the preparation enterprise to determine the variety before conducting the variety when conducting compatibility tests?
Pharmaceutical bag materials enterprises shall assist preparation companies to conduct compatibility tests。According to the announcement of the General Administration of Pharmaceutical Medical Accessories and Drug Review Approval, Article 3 provisions，From the date of the announcement，Pharmaceutical bag、The medicinal auxiliary materials shall be approved by the procedure and the drug registration application and review approval，"Requirements for the Requirements for the Application of Pharmaceutical Pharmaceuticals and Medicinal Accessories" will be announced separately。Food and drug supervision and management departments at all levels will no longer accept pharmaceutical packaging materials alone、Registration application for medicinal auxiliary materials，No longer issuing relevant registration approval documents。
After the implementation of the association review，Preparation Enterprise is the subject of quality responsibility，In the entire R & D stage, the applicability of the pharmaceutical packaging material should be studied and the compatibility of the drug。(This issue of answering experts is Tu Jiasheng, a professor at the University of Pharmacy)
Related review hundred questions (8)
Pharmaceutical packaging materials registered certificates are still within the validity period after January 1, 2018，Can it replace the approval or acceptance number?
Answer: According to the "Announcement of the General Administration on the Approval of Pharmaceutical Pharmaceutical Supplementary Materials and Pharmaceutical Review and Approval" Article 5，Approved Pharmaceutical Bag Material、Medicinal Accessories，The approved certification file continues to be valid during the validity period。After the expiry of the validity period，can continue to be used in the original medicine。When clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Approve the certification documents that expires before December 31, 2017 (including the day)、Medicinal Accessories，The validity period continues to December 31, 2017。From January 1, 2018，Drug clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Other medicinal auxiliary materials used in the history of drugs in the marketing drugs，can continue to be used in the original medicine。But when applying or production application for drug clinical trials for other drugs，The relevant information should be submitted according to the requirements of this announcement。
The pharmaceutical package supplementary materials registration certificate in the above problems is still within the validity period after January 1, 2018，It is still effectively used in the original product; the relevant information for the new product according to the announcement requirements。
Is there any risk level division of pharmaceutical packaging materials，How to change different risk levels?
Answer: According to the "Announcement of the General Administration on the Approval of Pharmaceutical Pharmaceutical Supplementary Materials and Pharmaceutical Review and Approval" Article 4，Pharmaceutical bag、Change the prescription of medicinal auxiliary materials、Craft、Quality Standard and other changes that affect the quality of the product，stake betting appIts production enterprises should actively carry out corresponding evaluations，Timely notify the drug production enterprise，and submit relevant information to the food and drug supervision and management department as required。Pharmaceutical bag、Relevant requirements for changes in medicinal auxiliary materials will be formulated separately by the State Food and Drug Administration。
The risk level of pharmaceutical packaging materials is mainly divided by routes，Pharmaceutical packaging and auxiliary materials companies should communicate in a timely manner with manufacturers，Pharmaceutical manufacturers should conduct self -assessment based on the degree of influence product quality risk，Application for changes in high -risk changes。(This issue of answering experts is Tu Jiasheng, a professor at the University of Pharmacy)
Related review hundred questions (9)
There is a medicine in June 2017 registered certificate,The medicine bag it uses is still within the validity period。If the pharmaceutical packaging material is registered, it needs to be filed first，Submit the information? Can the submitted information follow the original registered certificate of the medicine pack?
Answer: According to the General Administration of the General Administration of Pharmaceutical Medical Accessories and Pharmaceutical Review and Approval, Article 5 stipulates，Approved Pharmaceutical Bag Material、Medicinal Accessories，The approved certification file continues to be valid during the validity period。After the expiry of the validity period，can continue to be used in the original medicine。When clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Approve the certification documents that expires before December 31, 2017 (including the day)、Medicinal Accessories，The validity period continues to December 31, 2017。From January 1, 2018，Drug clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Other medicinal auxiliary materials used in the history of drugs in the marketing drugs，can continue to be used in the original medicine。But when applying or production application for drug clinical trials for other drugs，The relevant information should be submitted according to the requirements of this announcement。
The above -mentioned drug registration certificate expires，Pharmaceutical bags can continue to be used within the validity period。When registered with the pharmaceutical bag, it needs to be submitted to the material in accordance with the relevant regulations of the affiliate review。
Production enterprise submits a drug registration application，Pharmaceutical packaging materials used should be submitted during the validity period?
Announcement on the approval of the review and approval of the pharmaceutical packaging materials and drug associations，The drug packaging materials used for the application for the registration application can be used directly within the validity period of December 31, 2017。(This issue of answering experts is Tu Jiasheng, a professor at the University of Pharmacy)
Related review 100 questions (10)
Registered drugs replaced pharmaceutical bag materials (supplier)、How to declare the selection of drugs (suppliers)? How to review it?
Answer: At present, the "Announcement on the Related Matters of Pharmaceutical Pharmaceutical Supplementary Materials and Pharmaceutical Association Review and Approval" in the above issues does not have specific provisions for the above issues，Follow -up will be formulated by the State Administration of General Administration、Relevant guidelines for changes in medicinal auxiliary materials。The consensus formed by the regulatory authorities and the industry in the early stage of communication，Change suppliers should generally inform the regulatory authorities in the form of filing。
In terms of changes in pharmaceutical bag，It is only necessary to notify the pharmaceutical company as long as it is changed，Or is it notified when changing the quality of the package material? It is a contract material enterprise submitting a change application，Or submitted by a pharmaceutical company?
Answer: According to the "Announcement of the General Administration on Approval of Pharmaceutical Pharmaceutical Accessories and Drug Review Approval"，Pharmaceutical bag、Change the prescription of medicinal auxiliary materials、Craft、Quality Standard and other changes that affect the quality of the product，stake betting appIts production enterprises should actively carry out corresponding evaluations，Timely notify the drug production enterprise，and submit relevant information to the food and drug supervision and management department as required。Pharmaceutical registration applicants should master the pharmaceutical bag、Change of medicinal auxiliary materials，and study and evaluate the impact caused by the change，In accordance with the relevant provisions of the "Administrative Measures for Drug Registration", submit a corresponding supplementary application to the food and drug supervision and management department。Follow -up will be formulated by the State Administration to formulate a pharmaceutical bag、Relevant guidelines for changes in medicinal auxiliary materials。
Under the approval system of related review review，The change will be performed according to the size of the risk assessment。On the one hand, the risk assessment and control capabilities of preparation companies need to be strengthened，On the other hand, the supplier of pharmaceutical packaging materials and medicinal auxiliary materials should actively inform and cooperate with。In addition，The formulation of the Guide to change the guideline should also learn from European and American regulatory experience and industry practice，Refined application by the preparation enterprise based on the size of the change、Forms of filing and annual report，Create data to maintain updates for pharmaceutical packaging materials and auxiliary materials。(This issue of answers is Han Peng, deputy dean and academic director of Shenyang Pharmaceutical University Yimong Business College)
Related review hundred questions (11)
Pharmaceutical packaging materials manufacturers are changed when they change，Interesting to conceal the change，Drugs can not be discovered after the quality of the medicine，How to solve this problem?
Answer: This is also a problem that exists to exist in the review and approval of pharmaceutical packaging materials and drug review approval。Pharmaceutical packaging material manufacturers after obtaining approval number，blind spots in follow -up supervision，Some pharmaceutical packaging materials companies change processes not notify preparation companies using pharmaceutical bags，No application for supplementary applications，To a certain extent, the back of the pharmaceutical packaging material manufacturer and preparation production enterprise，The safety and effectiveness of the drug are great hidden dangers。National Food and Drug Administration implemented a medicinal bag material、Pharmaceutical Accessories and Drug Review Approval System，Fundamentally solve the problem of unclear responsibility of the previous management system。After the implementation of the related review and approval system，Clarified that the dosage company is the responsible subject of drug quality，Clarified that the dosage company is the responsible subject of drug quality，Including the safety of pharmaceutical packaging materials and medicinal auxiliary materials，Strengthen the daily audit of the supplier，Make sure the medicine bag material、The stability of the medicinal auxiliary materials process、The reliability of the process control and the stability of the product quality and the consistency between the batch。At the same time，Preparation companies should strictly screen pharmaceutical packaging materials or medicinal accessories suppliers，Sign quality agreement，Regular supplier audit and daily supervision。At the same time，It should be clearly reported in the agreement that the supplier should be reported in time or in advance if the process is changed and communicated in advance，From the legal level, solve the responsibility and obligation of the supplier change process to inform the preparation company，To ensure that the preparation enterprise is evaluated according to risk assessment，Confirm the impact on quality after the process of changes in the process of pharmaceutical packaging materials or medicinal auxiliary materials。(This issue of an expert in this issue is Hong Xiaoxu, deputy director of the General Division of the National My stake betting appMedicine Code。Expert views are for reference only。)
Related review 100 questions (12)
Do all the changes in the pharmaceutical bag notified the pharmaceutical company as soon as possible?
Answer: Any changes to the pharmaceutical bag，Pharmaceutical packaging material manufacturers should inform preparation manufacturers，Changes that have an impact on the quality of the pharmaceutical bag，Pharmaceutical packaging material manufacturers should take the initiative to carry out related research work，Provided to preparation companies more valuable、Data and information that is convenient for preparation companies to conduct corresponding evaluation。At the same time，Periodic enterprise to comprehensively evaluate the degree of changes in the supplier of regulatory packaging materials，Evaluate the degree of impact on the preparation。When the process or quality change of the pharmaceutical bag material affects the quality of the preparation，But when the agent acceptable range，Preparation Enterprise Enterprise Shopping Pharmaceutical Packaged Materials Enterprise Provide data to provide process changes，According to the Pharmaceutical Bag Material、Technical requirements for the technical declaration of medicinal accessories change，Supplementary applications for changing the corresponding changes in the medicine bag;。Before the assessment of the influence of the pharmaceutical packaging material change technology on the agent enterprise，Preparation enterprises shall require pharmaceutical bag material enterprises to suspend the process change。Of course，Not all changes need to be changed according to the supplementary application，Current，The relevant departments of the State Administration of General Administration are also organizing the formulation of technical requirements for changing pharmaceutical packaging materials and medicinal auxiliary materials，For the quality of some drug packaging materials or medicinal accessories, as well as the safety of preparations and auxiliary materials、Effective changes that affect the effect，Name specifications such as pharmaceutical bag、Changes in the location of enterprise registration，The method of filing can be taken without supplementary applications for changes。(This issue of answering experts Hong Xiaoxu, deputy director of the General Division of the National My stake betting appMedicine Code。Expert views are for reference only。)
Related review hundred questions (13)
Due to the inconsistency，How to evaluate the prescription of pharmaceutical bag materials、Craft、Standards and other changes?
Answer: The State Food and Drug Administration in the "Announcement on the Approval of Pharmaceutical Pharmaceutical Supplementary Materials and Drug Review Approval" (No. 134, 2016)、Pharmaceutical auxiliary materials manufacturers should be responsible for product quality; production should be organized under the conditions that meet the corresponding production quality management requirements;。Pharmaceutical manufacturers are implemented in accordance with attachment 2 "Pharmaceutical Pharmaceutical Supplementary Materials and Pharmaceutical Association Review Approval Procedures (Trial)"。
Pharmaceutical bag、Research on the quality comparison of drugs packaged medicines packaged directly contacting drugs before and after the change of the auxiliary materials，Comprehensive coverage of related substances、Color、Content and other key items，Provide stability，Research materials such as security and compatibility。The General Administration of the General Administration proposed in the "Requirements on the Requirement of the Pharmaceutical Pharmaceutical Accessories Reporting Information (Trial)" (Trial) (No. 155, 2016): Pharmaceutical manufacturers should grasp the pharmaceutical packaging material、Change of medicinal auxiliary materials，Research and evaluate in accordance with the principles of related technical guidance，Pharmaceutical bags that affect the quality of medicines、Change of medicinal auxiliary materials shall be supplemented in accordance with the relevant provisions of the "Administrative Measures for the Registration of Drugs"，For pharmacy materials that do not affect the quality of the medicine、Change of medicinal auxiliary materials shall be applied in accordance with the "Administrative Measures for Drug Registration".，Record from the provincial food and drug supervision department，Such as low borosilica glass, change to medium borosilica glass，If the registered certificate of the borosilicon glass of the borosilicon glass is still valid，There is no need to conduct association review，Only need to directly contact the packaging materials of the drug in accordance with the Measures for the Administration of Drug Registration。
Pharmaceutical bag、Accessories risk assessment and judgment based on the "Guidance Opinions of the Research on the Change of Chemistry for Chemistry" released by the drug review center。In the guidance principle, there is a detailed classification of the packaging materials and containers of the drug、Risk assessment and judgment。(This issue of answering experts is Liu Yan, including the Tianjin Pharmaceutical Inspection Institute, Liu Yan Expert's point of view is for reference only)
Related review hundred questions (14)
If you apply for a association review by the packaging system，But the packaging component is produced for different manufacturers，Can the component packaged materials obtained by the approved number can be used alone?
Answer: The State Administration of General Administration of the State Administration of the State Administration proposed in the "Requirements on the Requirement of the Pharmaceutical Pharmaceutical Accessories Reporting Information (Trial)" (No. 155, 2016): Encourage application to apply in accordance with the packaging system，If you cannot apply according to the complete packaging system due to some technical reasons，You can also apply according to the packaging component。During the associated review，Enterprises should try to apply according to a packaging system，Especially for high -risk preparations for medicinal bag materials，Each packaging system may produce different components by different manufacturers，But the composition of each component constitutes the entire packaging system，If one of the components is changed，It becomes another packaging system。The approval of the original pharmaceutical bag registration certificate also follows the principle of a packaging system and a set of materials，If there is a replacement component，All required information such as re -providing corresponding security and compatibility。So，Even if each component of the approved number is obtained，Still still in a packaging system to reflect the protection of related drugs，If the approval number of a single component is used alone in other packaging systems，Is not suitable。
What items should be detected in the plug extraction test?
Answer: Current，The Pharmaceutical Review Center of the State Administration of General Administration has not yet introduced the principle of compatibility guidance on the compatibility of the plug and medicine，According to the relevant information and some guidance principles announced，The extraction of the plug should also be performed according to the prescription of the plug。For example, the vulcanization method of plug，Antioxidant、Activative agent、Coloring agent，and other soft agents、Small molecular substances, etc.。Antioxidant of the plug: commonly used BHT et al.。Activant of the plug: Commonly used as hard fatty acid、Zinc oxide, etc.。Pluser of rubber plug: Commonly used titanium dioxide, etc.。For the gum plug，It also needs to perform a corresponding extraction test of the covering material。In short，The prescription of the plug is relatively complicated，Multiple aspects of extraction test。 20175_20193 Expert's point of view is for reference only)
Related review hundred questions (15)
In the announcement "Five、Approved Pharmaceutical Bag Material、Medicinal Accessories，The approved certification file continues to be valid during the validity period。After the expiry of the validity period，can continue to be used in the original medicine variety。When clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。"Question: 1. After the expiry of the validity period，Continue to use it in the original medicine，Do you need to go through the relevant procedures，For example, the application;、Medicinal Accessories，The validity period continues to December 31, 2017，Is the validity period automatic or need to write an extension application?
Answer: According to relevant documents，Approved Pharmaceutical Bag Material、Pharmaceutical auxiliary materials after the validity period expires，No need to go through extension procedures。
A variety of acceptance numbers obtained by a contract material corporate correction review，Is it applicable to other pharmaceutical factories of the same variety?
The acceptable pharmaceutical bag、Pharmaceutical Accessories and Drug Review Approval Procedures (Trial) file，The acceptable pharmaceutical bag、Medicinal Accessories，Drug clinical trials or production applications for other drugs，Can provide this pharmaceutical bag、Medicinal Express Materials "Notice of Acceptance"，No need to repeatedly submit relevant information。
According to the related policies of related reviews issued by the State Administration of General Administration，After obtaining a variety acceptance number of a contract material corporate corporate review，The acceptance number is the only，Other companies can query the acceptance number，Pharmaceuticals of the same variety can use the package material of the acceptance number。(This issue of the experts at the Professor of China University of Pharmacy, Tu Jiasheng expert point for reference only)
Related Reviews Hundred Questions and Answers (16)
2017 Year 12 month 31 Later after the day，After the registration certificate of the pharmaceutical bag that had already registered certificates before，If the original drug is still packaged，Do you need to declare in accordance with the related review procedures?
Answer: According to the General Administration of the General Administration of Pharmaceutical Medical Accessories and Drug Review Approval, Article 5 stipulates，Approve the document of the approved document on December 31, 2017 (including the day), the pharmaceutical bag material、Medicinal Accessories，The validity period continues to December 31, 2017 。From January 1, 2018，Drug clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Other medicinal auxiliary materials used in the history of the medicines in the marketing medicine，can continue to be used in the original medicine。But when applying or production application for drug clinical trials for other drugs，The relevant information should be submitted according to the requirements of this announcement。
The above problems, pharmaceutical packaging should be registered for re -registration.
Pharmaceutical packaging materials and drug association review approval procedures for trial and approval procedure，Pharmaceutical bag、When the auxiliary materials need to be declared，Is the material submitted to the provincial bureau or the pharmaceutical company used?
Answer: According to relevant regulations，Pharmaceutical bag、The medicinal auxiliary materials shall be reported with the clinical trial or production application of the drug，Related enterprises should fill in the "Pharmaceutical Bag Material Declaration Form" or "Pharmaceutical Express Materials Declaration Form"，Applicants who indicate the related drug registration applications、Drug name and acceptance number，Sales of the application information to the provincial food and drug supervision and management department where the local level is located。
If the pharmaceutical bag，If the pharmaceutical bag、Auxiliary materials for market sales，It needs to be submitted separately to the provincial bureau for review; if the pharmaceutical bag material、The auxiliary materials are binding with the medicine，Materials shall be handed over to the drug production enterprise for related declaration。
(This issue of the experts at the Professor of China University of Pharmacy, Tu Jiasheng expert point for reference only)
Related Reviews Hundred Questions and Answers (17)
"Announcement of the Pharmaceutical Pharmaceutical Supplementary Materials and Pharmaceutical Association Review Approval Council" release date is August 10 ，But is the registration certificate that has expired before release? What are the effective conditions?
Answer: The General Administration of the General Administration of Pharmaceutical Medical Accessories and Drug Review Approval Article 5 stipulates，Approved Pharmaceutical Bag Material、Medicinal Accessories，The approved certification file continues to be valid during the validity period。After the expiry of the validity period，can continue to be used in the original medicine。When clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Approve the document of the approved document on December 31, 2017 (including the day), the pharmaceutical bag material、Medicinal Accessories，The validity period continues to December 31, 2017 。From January 1, 2018，Drug clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。
Other medicinal auxiliary materials used in the history of the medicines in the marketing medicine，can continue to be used in the original medicine。But when applying or production application for drug clinical trials for other drugs，The relevant information should be submitted according to the requirements of this announcement。
According to the above announcement，The pharmaceutical bag registration certificate that has been expired before release can be automatically extended until the end of 2017。
Five "approval inspection reports in" Pharmaceutical Bags Reporting Information ": Provide not less than three batches of continuous production sample inspection reports"，Is it necessary to be inspected by a qualified unit for self -inspection? Is it full inspection or partial inspection according to the standard?
Answer: According to the relevant provisions of the application information of the pharmaceutical bag material，Batch inspection report should provide a test report for not less than three batches of continuous production samples。Former competent authorities required the qualification unit of pharmaceutical packaging materials enterprises to check three batches，and according to the DMF filing system，Pharmaceutical packaging materials can be inspected three batches of self -examination。(This issue of the experts at the Professor of China University of Pharmacy, Tu Jiasheng expert point for reference only)
