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Acceptance criteria for applying for drug production license
2020-09-12 10:51:26 Source:chuancheng IT

        1、 Purpose and basis of formulation

        Objective: to implement the requirements of laws and regulations, clarify the main responsibility of drug research and development institutions and the regulatory responsibilities of supervision and management departments, further promote the implementation of drug listing license holder system, release policy dividends, and serve the development of pharmaceutical industry in the whole province.

        Formulation basis: Drug Administration Law, measures for the supervision and administration of drug production, GMP, announcement on the implementation of the newly revised Measures for the supervision and administration of drug production (No. 47 in 2020) and the requirements of the system documents of the drug administration on the implementation of drug marketing license holders (hereinafter referred to as the holders).

      2、 Drafting background, process and principles

      Background: in August 2015, the State Council issued the opinions on the reform of the review and approval system of pharmaceutical medical devices (GF [2015] No. 44), which determined to carry out the drug marketing license holder system. On December 1, 2019, the newly revised "Drug Administration Law" was formally implemented, which determined to implement the drug marketing license holder system nationwide, and make it clear that the enterprises or drug development institutions that have obtained the drug registration certificate are the holders and bear the responsibility for the quality and safety of drugs in the whole life cycle. The implementation of the holder system is an important measure for the Party Central Committee and the State Council to deepen the reform of the review and approval system and encourage the innovation of pharmaceutical and medical devices. On March 31, 2020, the State Administration of Market Supervision issued the measures for the supervision and administration of drug production (Bureau order No. 28) (hereinafter referred to as the "production measures"), which further specified that the holders (including those who produce by themselves or by entrustment) should apply for drug production license. The State Food and Drug Administration issued the announcement on the implementation of the newly revised Measures for the supervision and administration of drug production (No. 47, 2020). Article 7 stipulates that those who are approved as holders in the form of entrusted production shall apply for licenses before July 1. However, it is a new requirement of SFDA to apply for a license as a holder. The national level has not formulated and issued relevant acceptance standards. Provincial drug administration departments should formulate corresponding inspection and acceptance standards for production license when carrying out this work.

        Process: in April 2020, our bureau started the drafting of production license inspection and acceptance standards, and formed the first draft according to the drug administration law, production methods, GMP and the relevant requirements of the State Drug Administration on the implementation of the holder system. After internal consultation, on-the-spot investigation and special seminar, public opinions were solicited on the Provincial Bureau website from May 13 to 26. On June 29, after the legitimacy review of the policy and regulation department of the Provincial Bureau, it was improved according to the audit opinions and formed the deliberation draft. On June 23, it was examined and approved by the Provincial Bureau board meeting.

        Principles: adhere to the people's health as the center, implement the "four strictest" requirements, adhere to the principles of risk management, whole process control, and science according to law, clarify the responsibilities and obligations of holders required by laws and regulations, further consolidate the main responsibility of enterprises, and ensure that the holders have the ability to guarantee safety, effectiveness and quality controllability.

        3、 Main contents and characteristics of acceptance standard

        There are 57 standards, including 26 key items (*) and 31 general items. The main contents and characteristics are as follows:

        (1) Highlight the main responsibility of the holder. It is clear that the holder shall not entrust the entrusted enterprise with the obligations and responsibilities legally performed by the holder through the quality agreement; the holder shall establish a quality management system to cover all factors affecting the quality of the drug; the holder shall establish a drug production risk management procedure linking with the entrusted party; the holder shall establish a management review procedure to evaluate the effectiveness of the quality management system It also clarifies the situations such as forbidding entrustment, re delegation and illegal entrustment.

        (2) Clarify the institutional setting and key personnel requirements of the holder. The holder shall establish an organization suitable for the drug quality management system; the person in charge of the enterprise, the person in charge of production, the person in charge of quality and the person authorized for quality shall be full-time, and the qualification of the personnel shall comply with the provisions of GMP and the production measures. Set up production director, production management responsibility and quality management responsibility can not be concurrently, need full-time personnel to control the production process.

        (3) Make sure that the holder shall establish a quality management system in accordance with GMP requirements. It is necessary to establish a quality management document system which can effectively link up with the entrusted party, establish a GMP document system covering the whole process suitable for the entrusted products, establish procedures for supervision, communication, review and approval, establish material management and audit system, establish deviation and change management system, establish risk management system, establish annual report system and drug traceability system and system; The key documents (such as process procedures, batch production records, process verification scheme / report, stability inspection scheme, etc.) shall be reviewed and approved by the holder; the holder shall regularly evaluate the facilities, equipment, production process and cleaning methods to ensure that the verification status can be maintained continuously; and the management procedures and responsibilities for effective connection between product marketing release and factory release shall be established.

        (4) Define the production quality management capability that the holder should have. The holder shall confirm that the entrusted party has the plant, facilities and equipment suitable for the production of the drug; the holder shall assign a special person to guide and supervise the whole process of the entrusted production; if the holder conducts self inspection, it shall have a quality control laboratory suitable for the inspection of raw and auxiliary materials, packaging materials, intermediate products and finished products and meet the GMP requirements; if the entrusted inspection is conducted, it shall confirm the undertaking of inspection Fang Youxiang