1. What is batch issuance?

Applied to the safety of the state drug regulatory department to ensure the safety of biological products such as vaccines、Effective，A review by a designated drug inspection agency before each batch of products is listed、Inspection and issued supervision and management behavior。This approach is an internationally regulatory approach to biological products such as vaccines，It is listed as one of the key functions of the governments of various governments to regulate vaccine biological products by the World Health Organization。my country has been breaking against Baibai since December 2001、CCP seedlings、Polish Cordyitis Vaccine、Measles vaccine、Reorganized hepatitis B vaccine, including 5 planned immunohoscopic vaccines, tried and issued，From January 1, 2006, all vaccines are approved and issued，January 2008，All blood products are incorporated into approval management。Compared with other vaccine producers in the world，my country's vaccine approval has a large number of enterprises、Multiple vaccine varieties、Published a batch more、Many crowds and other characteristics，The task of issuing the issuance is very heavy。Only 2016，my country is 51 varieties、3590 batches、646285.5 billion vaccines were approved and issued。

2. What is the background of the revision of the Measures?

The current "Administrative Measures for Biological Products Approval and Endema" (hereinafter referred to as the "Measures") Since its implementation in July 2004，To regulate the production of enterprises、Improve product quality、Promoting the orderly development of the industry has played an important role。But from the perspective of practice in recent years，With the rapid development of the biological product industry and the in -depth advancement of the reform of the drug supervision system，The relevant requirements of the current "Measures" cannot be fully adapted to the approval and issuance work，The main manifestation is: First, the sampling subject is issued for the approval、Sample liability、The process of the issuance process is not meticulous; the second is to the General Stake Sports Bettingstake online sports bettingAdministration、Provincial Bureau、The responsibility of the inspection department and the approval institution is not clear; the third is that the task time limit is not specific; the fourth is that the special treatment issued by the vaccine approved in emergencies is not provided。To strengthen the issuance management，The General Administration has launched the revision of the Measures in 2016。Through in -depth investigations and publicly soliciting domestic and foreign biological product manufacturers、Local drug supervision agency、Disease prevention and control agencies and industry organizations such as all sectors of society，Combining the actual situation of the development and supervision of the biological product industry，Completed the re -revision of the Measures。"Measures" has been reviewed and approved by the director office，will be officially implemented from February 1, 2018。

3. What are the main contents of the "Measures"?

New "Measures" total 8 chapters，respectively、Activity issuance agency determines、Application for issuing issuance、Review, inspection, inspection and issuance、Review、Information disclosure、Legal responsibility and attachment,Total 49 pieces，12 additions from the current "Measures"。The main modification content includes:
One is to further refine the work process of the approval and issue。Refined and improved the application procedure issued by the product，Added active communication、Question processing、Requirements for the treatment of risk management，Clearly emphasizes the requirements of the approval agency in the work process to actively verify on -site。
Second, it further clarifies the responsibilities of the relevant units and issued relevant units。Clarified the General Stake Sports Bettingstake online sports bettingAdministration、Provincial Bureau、Chinese Inspection Institute、Checking Center and other approval agencies，It specifies the product quality risk during the distribution process、Enterprise production defects or even illegal issues of illegal regulations、Treatment principles、Feedback method，After solving the major defects of the product and discovered the product，Due to the unclear departmental responsibility, the treatment lags、Questions of passive response。
Third is to further strengthen the main responsibility of the applicant who issued the applicant。Determine the quality and application information of the enterprise's issuing products、Record、The authenticity of the data is responsible;，Personnel such as the quality of the quality authorities should be reported actively when changing the changes in the changes of the personnel;、Craft、Supervision and other changes shall take the initiative to explain; at the same time, it is clear that the enterprise should take the initiative to find the reason for the issuing issues and issue the cause and recall it in accordance with regulations、Requirements for destruction。
Fourth, further clarify the requirements of the time limit for the issuance of the issuance of the issuance of the issuance of the issuance work。Starting calculation of the time limit for the issuance of batch、Stop it、Restore、Completion or termination of major nodes is clearly defined，Added the processing requirements for the processing and issuance of emergency disposal of public health incidents and force majeure。
Five is to further strengthen the management of the issuing agency。Application procedures for the entry of the issuance and issuance、Evaluation and evaluation requirements、The approval and issuance authority of the batch issuance agency has been clearly stipulated，At the same time, it has added and strengthened the legal liability that the regulatory authorities and the issuance agencies or personnel failed to perform their duties in accordance with the law or dereliction of duty。
Six is ​​to further enhance the transparency of the approval work。Added "Chapter 6 Information Disclosure" chapter，Clarified the requirements for the management and information disclosure of the information system，Public and batch applicants can query the progress of the approval through the information system、issued conclusions and information such as approval of the products (including products that have not been approved) have been completed (including the products that are not approved)。

4. Which products need to be approved?

"Drug Administration Law of the People's Republic of China" and the Regulations of the Implementation Regulations，Vaccine Products、Blood Products、Other biological products stipulated in the in vitro diagnostic reagent for blood sources and other biological products stipulated in the State Food and Drug Administration (hereinafter referred to as the State Food and Drug Administration)，Before the listing of each product or when it is imported or imported，All shall pass the issuance review inspection。Products that are not approved by approved，It is not allowed to sell or import。

5. What are the subjects and responsibilities of the application for the application?

Applying applicants should be domestic and overseas pharmaceutical companies holding the certificate of the drug approval document。Overseas pharmaceutical enterprises shall authorize its domestic office or corporate legal person to apply for approval。Before listing of each batch of products，Application for applications for approval shall take the initiative to submit the application for issuance and issuance，Performing the legal obligations in the approval activities according to law，Ensure that the quality of the products issued by the declaration is reliable and the application information issued by approval、Process Record、Test data and sample authenticity。

6. What are the agencies of batch issuance? What is the scope of its entry issuance?

The approval of the issuance agencies and its responsible for the issuance of the distribution of the distribution of the issuance of the Food and Drug Administration will determine。Current，Domestic approval inspection institutions include China Food and Drug Inspection Research Institute (hereinafter referred to as the Chinese Inspection Institute) and Beijing Drug Inspection Institute、Shanghai Food and Drug Inspection Center、Guangdong Pharmaceutical Inspection Center、Hubei Provincial Drug Supervision and Inspection Institute、Sichuan Food and Drug Inspection Inspection Institute、Jilin Provincial Drug Inspection and Gansu Provincial Drug Inspection and Research Institute。
Employed for vaccine approval，The Chinese Inspection My stake betting appstake online sports bettingInstitute can independently issue all vaccine varieties。Seven provincial pharmaceutical inspection agencies are responsible for designated project tests such as sterile and abnormal toxicity of enterprise vaccine products in the region，and submit the results to the Chinese Inspection Court。Shanghai Drug Inspection Institute Except for the specified project inspection mentioned above，From April 9, 2013，It can be independently issued to issue an influenza vaccine approved by the applicant in the designated area。
Employment of blood products，The Chinese Inspection My stake betting appstake online sports bettingInstitute can independently issue all blood products，Seven provincial pharmaceutical inspection institutions can independently issue blood products of enterprises in the designated area and human hemium albumin products imported from the corresponding jurisdiction。
Current，The in vitro diagnostic reagent for blood sources screening is approved by the Chinese Inspection Institute。
Seven provincial pharmaceutical inspection institutions are responsible for approval and issuing management areas as follows:
Beijing Drug Inspection Institute: Beijing、Tianjin、Hebei Province、Shanxi Province and Inner Mongolia Autonomous Region
Shanghai Food and Drug Inspection Institute: Shanghai、Shandong Province、Jiangsu Province、Zhejiang Province
Jilin Provincial Drug Inspection Institute: Heilongjiang Province、Jilin Province and Liaoning Province
Hubei Provincial Drug Supervision and Inspection Institute: Hubei Province、Anhui Province、Jiangxi Province and Henan Province
Guangdong Pharmaceutical Inspection Institute: Guangdong Province、Hunan Province、Fujian Province and Hainan Province
Sichuan Food and Drug Inspection Inspection Institute: Chongqing City、Sichuan Province、Yunnan Province、Guizhou Province、Guangxi Zhuang Autonomous Region、Tibet Autonomous Region
Gansu Provincial Drug Inspection Research Institute: Shaanxi Province、Gansu Province、Ningxia Hui Autonomous Region、Qinghai Province and Xinjiang Uygur Autonomous Region

7. What conditions should be met to become approved and issued institutions?

Food and Drug Administration based on the needs of the approval work，Objects in time to announce the selection standards and conditions for the expansion and issuance of the existing batch of the issuance agencies。The application of the pharmaceutical inspection institution that applies to become a batch of institutions shall meet the selection criteria and conditional requirements，and pass the ability assessment and assessment by the Chinese Inspection Institute。Food and Drug Administration determines the approval of the corresponding variety by the drug inspection agency based on the assessment results，or the scope of the distribution of batch issuance for the establishment of the establishment of the establishment of the establishment of the establishment of the batch and issuance agencies。

8. How to apply for the newly approved biological product to apply for approval?

Newly approved the listing of biological products before applying for the first application for issuance，Applying applicants for batch shall submit relevant materials to the Chinese Inspection Institute，Application for registration in the information management system for the issuance of the information management system。Related information meets the requirements，The Chinese Inspection Institute will complete the registration confirmation work of the application variety in the approved information management system within 10 days。Information about enterprises and products will be entered into the issuance system，At the same time, specify the agency to undertake the product batch of the product。Apply for applicants to issue a system with the key，Fill in the approval application form，You can officially apply for the approval of specific batch products。

9. How to batch product sampling?

Apply for applicants to issue an application form to the provincial food and drug supervision and management department or its designated sampling agency with biological products，Sample personnel organize on -site sampling within 5 days,and sealed the samples。Applying applicants will send the seal sample to the approved and issued agency to apply for registration，At the same time, according to the 15th、Article 16 of the provisions submit a approval application information。
Provincial food and drug supervision and management department is responsible for organizing sampling work of batch products produced or imported by the area under its jurisdiction，Determine the relatively fixed sampling agencies and personnel and the filing of the issuing agency for the record，Training for regular sampling institutions and personnel，Supervisory and guidance of sampling work。

10. What are the specific working forms issued by batch?

"Measures" stipulates that approval and issuance can adopt information review，You can also take the combination of data review and sample inspection，and can be verified on -site as needed。stake online sports bettingstake sports betting appA review of biological products approval、The standard for inspection is the drug registration standard approved by the State Administration of Food and Drug Administration，and should meet the requirements of the Pharmacopoeia of the People's Republic of China。A batch of issuing agencies can inspect any inspection items in any content of the registered standards specified in the Pharmacopoeia and the Registration Standard content approved by the General Administration，and can be tested by other specific projects according to the needs of regulatory work。The approval method and inspection items and inspection ratio used for different varieties，The Chinese Inspection Institute is responsible for organizing demonstration，Each batch of issuance agencies are inspected in accordance with the determined approval method and inspection requirements。

11. How is the inspection project and the inspection ratio of batch?

A batch of issuance agencies in the process of issuing the specific variety，You can control maturity according to the process and quality of this variety、Comprehensive assessment of previous situations and other situations，Dynamic adjustment of the inspection items and inspection frequency of this variety。After the issuance of the product is unqualified,，A batch of issuance agencies shall increase the test frequency of the corresponding projects of subsequent batch products。
A batch of issuance agencies shall be based on the previous quality management of the applicant to issue the applicant、Corresponding variety of process maturity and stable product quality, etc.，On -site verification of different proportions of products issued by the approved products，And can test the sample as needed。

12. What are the cases that need to be tested in all projects?

One of the following situations，Products shall be inspected all projects in accordance with the registration standard，At least the three batches of products produced at least continuously produced after the issuance is qualified，can be performed by some project inspections:
(1) Applying to the products approved by the Sanior Drug Administration approved to be listed by the applicant's new Food Drug Administration;
(2) If the production site is changed and approved;
(3) If the production process is changed and approved;
(4) The product has not been applied for issuance for two consecutive years;
(5) For violating relevant laws and regulations, they were ordered to be approved after production and were approved to be restored to production;
(6) There may be potential risks with the quality or quality control of the corresponding product;
(7) Other situations that need to be inspected all three consecutive batches of project inspection。

13. How is the working time limit for the issuance agency?

A batch of issuing agencies shall complete the issuance of the vaccine products within 60 days，In vitro diagnostic reagents for blood products and blood source screening shall be issued within 35 days。If you need to re -test，The time limit for issuance of the issuance of the issuance can extend the two inspection cycles of the inspection item，and inform the approved applicant。Due to the characteristics of the variety characteristics and the reasons of the inspection items, it is necessary to extend the time limit of the approval time，After being reviewed and determined by the Chinese Inspection Institute。
What needs to be explained is，Time to make up the application of the applicant's correction information、On -site verification、On -site inspection and technical assessment time is not included in the approval time limit。
A batch of issuance agencies due to force majeure or emergency response disposal of public health events，Not being able to complete the issuance of the issuance work within the prescribed time limit，The time limit for the extension of the approval should be issued、Reasons and expected recovery time Written notifications to issue applicants。It is really difficult to complete，It is borne by other approved agencies coordinated by the Chinese Inspection Institute。

14. What are the products that cannot be issued through approval? How to deal with these products?

One of the following situations，A batch of issuing agencies will not be issued for issuance，The notice of issuing biological products will not be issued to the applicant to the applicant to the biological product，Copy and copy the provincial food and drug supervision and management department where the applicant is located:
(1) Data review does not meet the requirements;
(2) The sample test is not qualified;
(3) On -site inspection found that it violates the quality management specifications of drug production、There are serious defects;
(4) On -site inspection found that the product has systemic quality risks;
(5) Apply for applicants for no proper reasons，If the information is not made within the prescribed time limit;
(6) Others My stake betting appwho stake sports betting appdo not meet the requirements of laws and regulations.
Products that are not approved，The provincial food and drug supervision and management department of the local area is destroyed by the provincial food and drug supervision and administration department to supervise and issue the applicant for the application of the applicant。Imported biological products are supervised and destroyed by the food and drug supervision and management department where the port is located，or return to overseas manufacturers。Applying applicants shall report the destruction records at the same time and report the food and drug supervision and management department and the corresponding approval institution。

15. Is it necessary to be safe and effective if the products issued by approved?

Applying is the enterprise submitted an application after completing the product production and self -inspection，A review by the approval agency、Inspection of a kind of supervision and management behavior。Because each batch of products need to be declared，and more biological product inspection items、Time -consuming，To ensure that the product can enter the market in time、Meeting supply，The international approach is to adopt the method of combining data review and laboratory inspection，It is a batch to check for some batches，instead of performing a full inspection of each product by the batch of products。So，Applied issuance is based on the application materials and samples submitted by the enterprise，Have a certain limitations，It is not the only means to ensure product quality。The product is issued by approval，Explain that the application information and the results of the inspection of the product at the time (if any) show its production compliance、Self -inspection Qualification、Quality control indicators meet the drug registration standard，Safety、Effectiveness is guaranteed。
After the enterprise products are issued through approval，Delivery、Sales、Storage until clinical use and other links should be operated in accordance with regulations，There is a problem with any link，May affect product quality。Sometimes even because of corporate technology or product stability problems，The situation where the product cost decreases before the approaching period。So，The management of vaccine biological products is a systematic engineering，Applying and listing license、Monitoring after listing、Laboratory management、Daily supervision of production and sales and clinical trial supervision jointly constitute a complete national vaccine management system。At the same time，Production enterprise as the first responsible person in product quality，shall bear the management of the entire life cycle management of the distribution of products，Production of product production、Sales delivery、Bad reaction reports, etc. bear all legal liability。

16. How do the public check the results of the batch of products?

The batch issuance agency shall publicize the issuance of information such as publicly approved the conclusion and other information within 7 days after each batch of products of the agency's products。Public can be based on the vaccine name、Batch number and production enterprise name query whether the batch of products are qualified。For batches information that has not been approved by batch issuance，A batch of issuance agencies will also be made public。