Medicinal Accessories is an important part of the medicine，The quality of the medicine directly affects the medicine。To further strengthen the production of medicinal accessories、Supervision used，Ensure the quality and safety of the medicine，According to the "Pharmaceutical Management Law of the People's Republic of China" and the Implementation Regulations、"Special Regulations on Strengthening the Safety Supervision and Management of Food and other products such as food"、"Measures for the Supervision and Management of Drug Production"、"Administrative Measures for Registration of Drugs"、"Specifications for the Management of Drug Production Quality" and other related laws and regulations，Special regulations are as follows:

a、Drug preparation manufacturers must ensure the quality of purchasing medicinal accessories
(1) Drug preparation manufacturers are the responsible person of the drug。Must strengthen the quality management of drug production，Ensure the quality and safety of the medicine。Management of strict medicinal accessories must be used，Prescription process approved by the drug supervision and management department，Use the pharmaceutical auxiliary materials to produce drugs that meet the requirements。Drug quality issues caused by medicinal accessories caused by illegal and illegal regulations，Drug preparation manufacturers must bear the main responsibility。
(2) Drug preparation manufacturers must improve the quality management system。To ensure the effective performance of quality assurance and quality control of the quality management department，The person in charge of the enterprise and other departments shall not interfere or hinder the quality management department to perform their duties。OK supplier of medicinal accessories should be audited and approved by the enterprise quality management department。
(3) Drug preparation manufacturers should strengthen the audit of pharmaceutical accessories suppliers。The relevant requirements should，Regular quality assessment of pharmaceutical auxiliary materials stake online sports bettingproduction enterprises，Make quality audit and retrospective stake sports betting appanalysis Stake Sports Bettingof the quality system of pharmaceutical auxiliary materials production enterprises，Create the quality archives of all the purchasing medicinal accessories and suppliers。
(4) Drug preparation manufacturers must strictly control the quality of medicinal accessories used。Any medicinal auxiliary materials purchased，All must be tested in accordance with the quality standards approved by the drug approval，Make sure to meet the medicinal requirements。For medicinal auxiliary materials that have been promulgated by national drugs，It must meet the requirements of national drug standards。
(5) Drug preparation manufacturers shall sign the quality agreement with the main medicinal auxiliary materials supplier。Master the change of the medicinal auxiliary materials used at any time，Research and evaluation changes on the impact of drug quality，and declare in accordance with the requirements of the "Administrative Measures for the Registration of Drugs"。

2、Pharmaceutical auxiliary materials manufacturers must ensure the quality of the product
(6) Medical auxiliary materials manufacturers must be responsible for product quality。Strict implementation of the "Management Specifications for the Management of Medicinal Accessories Production Quality"，Improve corporate quality management system，Strengthen the audit of suppliers of raw materials used in production，Strict raw material quality control，Organization of prescription process organizations approved by product registration，Standardize the preparation of product batch number，Make sure the product quality is stable。Medicinal auxiliary materials that have not obtained the approval number and are used in history，Organize production in accordance with the quality agreement stipulated in the drug preparation stake online sports bettingproduction enterprise。
(7) Medical accessories manufacturers must ensure product quality。Quality standards shall be based on registered or approved or agreed with the contract with the drug preparation enterprise，Perform the full inspection of each product，Only after qualified、Sales。For medicinal auxiliary materials that have been promulgated by national drugs，It must meet the relevant requirements of national drug standards。Before the product release，All production documents and records，Including the inspection data shall be reviewed by the quality management department and meets the requirements，Do not meet the requirements and leave the factory。
(8) Medical auxiliary materials manufacturers shall cooperate with drug preparation manufacturers to conduct supplier audit。If the production process occurs、Source of raw material sources, etc., may affect the change of medicinal access to the quality of medicinal accessories，The corresponding assessment should be carried out in the initiative，Timely notifying the drug preparation stake online sports bettingproduction enterprise。

3、Drug supervision and management department implements classification management of medicinal accessories
(9) Classification management of pharmaceutical accessories implementation。Permit management of new medicinal auxiliary materials and high -safety risks，That is，variety must be registered permit; implementation management of other auxiliary materials，That is, the stake online sports bettingproduction enterprise and its products My stake betting appare filing。The catalog of licensed management is formulated by the State Food and Drug Administration，announced in batches。
Medicinal auxiliary materials for implementing permit management，stake online sports bettingproduction enterprises shall submit relevant information as required。The provincial drug supervision and management department conducts production site inspections in accordance with the requirements of the "Management of the Quality Management of Medical Accessories"，Dynamic sampling test，After passing the review by the State Food and Drug Administration，Registered。The National Food and Drug Administration shall be associated with the corresponding pharmaceutical preparations for the review application of the auxiliary materials。
Medicinal accessories for implementing filing management，Submit relevant information by the manufacturer，The report of the provincial drug supervision and management department of the newspaper where the newspaper is located。Provincial drug supervision and management department can conduct on -site inspection and sampling inspection as needed。
The relevant requirements of the medicinal auxiliary materials permit and filing will be formulated separately。Imported drug accessories refer to this regulation，Report to the State Food and Drug Administration for permission or filing。
(10) Strict requirements for drug registration and application for medicinal auxiliary materials。Pharmaceutical preparation manufacturers when applying for drug registration，Types of medicinal accessories used for submitted to the submission、Supplier、Quality standards and supplier audit results; supplementary applications for changing the types of medicinal accessories，Corresponding research should be conducted，Submit research data and supplier audit results，It can only be used after being approved by the State Food and Drug Administration; for the type of supplementary material that does not change the type of auxiliary materials，Need to submit the corresponding research data and supplier audit results，Only filed with the provincial drug supervision and management department can be used。
(11) Enhanced medicinal auxiliary materials standard management。The State Food and Drug Administration organizes the revision of the National Pharmacopoeia Council to carry out the amendments to the quality standard system of pharmaceutical auxiliary materials，Release of the National Drug Standards for Pharmaceutical Accessories，Research and formulation of pharmaceutical accessories recommendation standards。Drug supervision and management departments at all levels conduct supervision and inspection in accordance with national drug standards。

4、The drug supervision and management department must strengthen the entire process of production and use of pharmaceutical accessories
(12) The local drug supervision and management departments at all levels shall implement supervision responsibility。To strengthen the daily supervision of drug preparation manufacturers in this administrative area，Key check whether the drug preparation manufacturer is produced according to the approved process; whether it is audited by the supplier's audit requirements; Whether to change the medicinal auxiliary materials without stake online sports bettingauthorization; whether the supplier changes the requirements as required, etc.。
stake sports betting app(13) The local drug supervision and management departments at all levels shall strengthen the production supervision of medicinal accessories。Daily supervision of pharmaceutical auxiliary materials manufacturers in this administrative area，Or according to the supervision and inspection of the drug preparation manufacturer，Extension inspection of pharmaceutical accessories manufacturers。Key check whether the production of medicinal auxiliary materials is in line with the "Regulations for the Management of the Quality Management of Medical Accessories"; whether the quality of raw materials is strictly controlled; whether it is produced in accordance with the processing or filing process;。For not receiving inspection，Pharmaceutical preparation manufacturers shall not use the medicinal auxiliary materials they produce。
(14) Drug supervision and management departments at all levels shall strengthen the supervision of medicinal accessories。According to the situation of supervision and inspection，Clear key points，Refined scope and requirements。The scope of the test should cover the use of medicinal auxiliary materials such as pharmaceutical auxiliary materials and drug preparation manufacturers。Enterprises and institutions found in previous supervision and inspections，To increase the frequency of drawing and inspection。
(15) Drug supervision and management departments at all levels should increase investigation and punishment。Discovering a drug preparation manufacturer、Pharmaceutical auxiliary materials stake online sports bettingproduction enterprises in the production of medicinal auxiliary materials、illegal and violations of the rules，It should be in accordance with the "Pharmaceutical Management Law of the People's Republic of China"、"Special Regulations on Strengthening the Safety Supervision and Management of Food and other products such as food and other products" and other relevant regulations on relevant enterprises and responsible persons，The serious plot，Strictly deal with it in accordance with the law。For the crime，Transfer to the public security organs，Criminal liability for investigation in accordance with the law。

5、Focus on basic data construction，Establish an integrity management mechanism
(16) Establish a medicinal auxiliary materials database。Drug preparation manufacturers shall use the medicinal auxiliary materials approved by the drug supervision and management department，Fill in the use information of the medicinal auxiliary materials in the product，and notify and assist the pharmaceutical auxiliary materials stake online sports bettingproduction enterprises to fill in the production of medicinal accessories，Report to the provincial drug supervision and management department of the respective locations。State Food and Drug Administration and provincial drug supervision and management department summary relevant information，Establishing a medicinal auxiliary materials database，Fully master the production of medicinal accessories、Dynamic situation used。
(17) Establish a credit archives for pharmaceutical auxiliary materials stake online sports bettingproduction enterprises。Provincial drug supervision and management departments shall establish a credit archives for pharmaceutical accessories manufacturers，Public inspection of pharmaceutical auxiliary materials production enterprises、Tips，Reference for drug preparation manufacturers when selecting medicinal auxiliary materials。
(18) Encourage the public to participate in supervision and management。Support Industry Association、Third -party institutions and stake sports betting appthe public supervise and report illegal and illegal acts in the production and use of medicinal accessories，Maintenance of the quality Stake Sports Bettingand safety of drugs and medicinal accessories。Relevant Industry Association should strengthen industry self -discipline，Promote the construction of integrity of the industry，Promote Classification Management，Guidance Standardize the integrity of drug preparation manufacturers and medicinal auxiliary materials manufacturers，Operation according to law。
This regulation is responsible for explanation by the State Food and Drug Administration，Execution from February 1, 2013。