In order to implement the Opinions of the General Office of the Communist Party of China Central Committee and the General Office of the State Council on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices (Ting Zi [2017] No. 42), the former State Food and Drug Administration issued the Announcement on Adjusting the Evaluation and Approval Matters of Raw Materials, Pharmaceutical Auxiliary Materials, and Drug Packaging Materials (2017 No. 146). The following announcement further clarifies the related matters of evaluation, approval, and supervision of raw materials, pharmaceutical auxiliary materials, packaging materials and containers that directly contact drugs (hereinafter referred to as raw materials and auxiliary packaging) and drug preparations: 1、 Overall requirements （1） The use of original and auxiliary packaging must comply with pharmaceutical requirements, mainly referring to the quality, safety, and functionality of the original and auxiliary packaging that should meet the needs of drug formulations. The review and approval of the association between the original auxiliary package and the drug preparation shall be registered by the registrant of the original auxiliary package on the registration platform. When the applicant for drug preparation registration submits the registration application, it shall be associated with the registration information on the platform; For original and auxiliary packages that cannot be registered on the platform due to special reasons, the applicant for drug formulation registration can also provide research materials on the original and auxiliary packages together with the drug formulation registration application. （2） The original and auxiliary package registrant is responsible for maintaining the registration information on the registration platform and is responsible for the authenticity and completeness of the registration materials. Domestic original and auxiliary package suppliers, as the original and auxiliary package registrants, shall register their own products. Overseas original and auxiliary package suppliers can be registered by their permanent representative offices in China or by authorized Chinese agencies. The registration information should be in Chinese, and both the overseas original and auxiliary package suppliers and the agency are jointly responsible for the authenticity and completeness of the registration information. （3） When the applicant for drug preparation registration applies for drug registration, they need to provide the original auxiliary package registration number and the authorization letter of the original auxiliary package registrant. （4） The applicant for drug preparation registration or the holder of drug marketing authorization shall bear the main responsibility for the quality of the drug. According to the relevant requirements of drug registration management and post marketing production management, the quality management system of the original packaging supplier shall be audited to ensure compliance with pharmaceutical requirements. （5） The regulatory authorities have a confidentiality responsibility for the technical information submitted by the original auxiliary package registrant, and keep the technical information of the registration platform confidential. The registration platform only publicly discloses the registration status identification (A or I), registration number, variety name, enterprise name (agency name), enterprise production address, original drug approval number (if any), validity period of the original approval certificate (if any), product source, specifications, update date, and other necessary information of the registered variety.
2、 Product registration management （6） The original and auxiliary package registrant shall register on the platform according to the technical requirements of the registration information and obtain a registration number. Among them, active pharmaceutical ingredients should obtain the corresponding "Drug Production License" for the production scope before registration, and register in accordance with the requirements of the "Notice on Issuing the Requirements for New Registration Classification Application Materials for Chemical Drugs (Trial)" (No. 80 of 2016) issued by the former Food and Drug Administration; The registration of pharmaceutical excipients and packaging materials shall be carried out in accordance with the data requirements in Annex 1 and Annex 2 of this announcement. The technical requirements for registration data shall be continuously improved according to industrial development and scientific and technological progress, and shall be updated and published by the Drug Evaluation Center of the National Medical Products Administration (hereinafter referred to as the Drug Evaluation Center) in a timely manner. （7） The registration application for drug preparations is associated with the registered original and auxiliary packages. When the drug preparation is approved, it indicates that the associated original and auxiliary packages have passed the technical review, and the registration platform is marked as "A"; The identification that has not passed the technical review or has not been associated with the formulation registration is "I". （8） Except for the original and auxiliary packages that are prohibited, phased out, or cancelled by the state, those that meet the following conditions will have their relevant information transferred to the registration platform by the drug review center and given a registration number, with the registration status marked as "A": 1. Raw materials with an approval certificate that expires no earlier than November 27, 2017; 2. Raw materials that have been accepted and approved for review, including applications for technology transfer of raw materials reviewed by the provincial bureau in accordance with the State Food and Drug Administration Notice [2013] No. 38; 3. Pharmaceutical excipients and packaging materials that have been accepted and reviewed; 4. Pharmaceutical excipients that have obtained approval documents; 5. Drug packaging materials with an approval certificate that expires no earlier than August 10, 2016. The registrant of the original auxiliary package transferred to the registration platform shall supplement and submit research materials, improve registration information, and submit a commitment letter for data consistency (promising that the technical data submitted by the registration platform is consistent with the approved technical data) in accordance with the registration information requirements of this announcement. （9） The raw materials used for imitating or importing domestically marketed drug preparations can undergo separate review and approval after being registered by the raw material registrant. The registration status of those who pass the review and approval is marked as "A", and those who fail the review and approval are marked as "I". The time limit and requirements for review and approval shall be implemented in accordance with relevant regulations such as the current Measures for the Administration of Drug Registration. （10） Medicinal excipients that have been used for a long time in food and medicine and have been recognized for their safety do not need to be registered (see Annex 3 for the list). The applicant for drug formulation registration shall list the product list and basic information in the formulation application materials. However, if the drug review center deems it necessary during the evaluation process of drug formulation registration applications, it may require the drug formulation registration applicant to provide corresponding technical information. The list of medicinal excipients of this type shall be updated and published by the Drug Evaluation Center in a timely manner. （11） The administrative license for medicinal excipients and drug packaging materials has been cancelled, and no fees will be charged for platform registration. Raw materials are still subject to administrative licensing, and the platform registration technical review requirements shall be implemented in accordance with current regulations and standards.
3、 Use and management of registration information for original and auxiliary packages （12） When applying for associated review of drug preparation registration, if the research data of the original auxiliary package registration platform cannot meet the needs of the review, the drug review center may require the drug preparation registration applicant or the original auxiliary package registrant to supplement it. The submission method for supplementary information shall be specified by the Drug Review Center in the supplementary notice. （13） If the raw material is marked as "A", it indicates that the raw material has passed the review and approval. The registrant of active pharmaceutical ingredients can print approval documents, quality standards, labels, etc. on the registration platform for handling GMP inspections, import customs clearance, etc. Raw materials that have not been registered on the platform but have submitted research materials together with the drug formulation registration application materials can be used to handle GMP inspections, import customs clearance, etc. by the regulatory authorities in the drug formulation approval certificate document, indicating relevant information of the raw materials. （14） Raw material manufacturing enterprises shall apply for GMP inspection procedures and requirements in accordance with relevant laws and regulations. After passing the drug GMP inspection, they shall update their registration information on the registration platform. （15） If there is a technical change in the raw material marked as "A", a change application shall be submitted in accordance with the relevant regulations of the current drug registration management, and shall be implemented after approval. Other changes in raw materials, pharmaceutical excipients, and packaging materials should be updated on the registration platform in a timely manner and summarized in the previous year's annual report submitted in the first quarter of each year. （16） When there is a change in the original auxiliary package, the registrant of the original auxiliary package should actively conduct research and promptly notify the relevant drug formulation production enterprises (drug marketing authorization holders), update the registration information in a timely manner, and reflect it in the annual report. After receiving the above notice, pharmaceutical preparation manufacturers (holders of drug marketing authorization) should promptly evaluate or study the impact of corresponding changes on the quality of pharmaceutical preparations. If it affects the quality of pharmaceutical preparations, a supplementary application should be submitted. （17） If the original packaging and supplier of the original packaging of a marketed drug formulation are changed, research should be conducted in accordance with the requirements of the "Technical Guidelines for Research on Changes in the Production Process of Marketed Chemical Drugs (1)", "Technical Guidelines for Research on Changes in the Production Process of Marketed Chemical Drugs (1)", "Technical Guidelines for Research on Changes in the Traditional Chinese Medicine of Marketed Drugs (1)", and relevant guidelines for research on changes after the marketing of biological products, and should be implemented in accordance with the relevant regulations on drug registration management. （18） If the overseas original and auxiliary package supplier changes the registration agency, the relevant documents and materials shall be submitted for the change. Including: explanation of the reason for the change, power of attorney from the overseas original and auxiliary package supplier, notarized documents and their Chinese translations, copy of the new agency's business license, documents for the overseas original and auxiliary package supplier to terminate the original agency's entrusted relationship, notarized documents and their Chinese translations.
4、 Supervision and management （19） The drug regulatory authorities of each province (region, city) shall conduct post market management and GMP inspections on active pharmaceutical ingredients with a registration status marked as "A" according to the drug. （20） The drug regulatory authorities of each province (region, city) should strengthen the supervision and inspection of drug preparation production enterprises (drug marketing authorization holders) within their administrative regions, and urge drug preparation production enterprises (drug marketing authorization holders) to fulfill their supplier audit responsibilities for raw materials, pharmaceutical excipients, and drug packaging materials. Pharmaceutical excipients and pharmaceutical packaging materials production enterprises with a "Drug Production License" shall continue to be managed in accordance with the original management requirements. After the license expires, the site information shall be registered in accordance with the requirements of this announcement. （21） The drug supervision and administration bureaus of each province (region, city) shall strengthen supervision, inspection, and extended inspection of suppliers of pharmaceutical excipients and packaging materials based on registration information. If quality problems are found in the production of pharmaceutical excipients and drug packaging materials, they should be investigated and dealt with in a timely manner in accordance with laws and regulations, and drug preparation production enterprises (drug marketing authorization holders) should be required not to use related products, and evaluate and dispose of already marketed products. The extended inspection should be organized and carried out by the provincial bureau where the drug formulation production enterprise (holder of drug marketing authorization) is located. The daily inspection of suppliers of pharmaceutical excipients and drug packaging materials is organized by the local provincial bureau for joint inspection. The on-site inspection of pharmaceutical excipient production shall be carried out in accordance with the "Quality Management Specification for Pharmaceutical excipient Production" (National Medical Products Administration [2006] No. 120), and the on-site inspection of pharmaceutical packaging materials shall be carried out in accordance with the "General Rules for the Assessment of Pharmaceutical Packaging Materials Production Sites" attached to the "Management Measures for Packaging Materials and Containers in Direct Contact with Drugs" (formerly Order No. 13 of the State Food and Drug Administration). The drug regulatory authorities of each province (region, city) may further improve relevant technical specifications and inspection standards according to regulatory needs, and promote the steady improvement of the quality level of excipients and drug packaging materials. The National Medical Products Administration will revise relevant inspection standards in a timely manner based on the supervision and inspection situation and needs of each province. 5、 Other （22） Raw materials, pharmaceutical excipients, and packaging materials developed, produced, imported, and used within the territory of the People's Republic of China are subject to the requirements of this announcement. （23） This announcement will come into effect on August 15, 2019. If the original and auxiliary package related documents published are inconsistent with the requirements of this announcement, this announcement shall prevail. The Notice on Issuing the Requirements for Application Materials of Pharmaceutical Packaging Materials and Auxiliary Materials (Trial) (No. 155 of 2016) issued by the former State Administration for Market Regulation is hereby abolished. This is to announce. Attachment: 1. Requirements for Registration Data of Medicinal Excipients (Trial) 2. Requirements for Registration Data of Drug Packaging Materials (Trial) 3. Catalogue of products exempt from registration (2019 edition) 4. Basic requirements for annual reports of pharmaceutical raw materials and packaging materials SFDA July 15, 2019