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            Location: Home > News > Industry news

            Revision of the Drug Administration law, abolition of GMP/GSP Certification

            Date:2018/6/25 10:50:26 Reading:553

            Recently, the StateFood and Drug Administration has issued a revised draft of the Drug Administration Law of the People's Republic of China. The main contents of the revised draft are as follows:
            The draft amendment draft has added 6 articles to the current drug administration law, amended 9 articles and deleted 2 articles. The main amendments include:
            (1) We will fully implement the drug marketing listing license holder system The draft summarizes the pilot experience of the drug listing license holder system and fully implements the drug listing license holder system. One is to add an article in the General Provisions to clarify that the country implements a system of license holders for drug listing, and that holders of drug listing licenses shall bear legal liability for the safety, effectiveness and controllability of drugs (Article 5). Secondly, in Chapter 5 of the "Drug Administration" to add the relevant content of drug listing license holders, Specify that the applicants who obtained the number of Drug Approval Document asdrug listing license holders (Article 31), drug listing license holders can produce and sell drugs on their own or entrust others to produce and operate. The holder of a drug listing license shall bear all legal liabilities for preclinical research, clinical trials, production and marketing, and adverse drug reaction reports, and the holder of a drug listing license abroad shall designate an agent to jointly assume legal liabilities (Article 32); the holder of a drug listing license shall be the subject responsible for the reappraisal of a drug Article 34. Thirdly, the holders of drug listing licenses (Article 34, Article 52, Article 54, Article 70, Article 71 and Article 79) shall be added to the relevant legal obligations and legal liabilities, or the pharmaceutical manufacturing enterprises shall be changed into the holders of drug listing licenses (Articles 55 and 56) Articles 58, 89, 90 and 92 are in line with the provisions of the current Drug Administration Law.

            (2) Implement the reform requirements of the administrative examination and approval system. The institution of clinical trial shall be changed from certification to record, the approval of drug clinical trial shall be changed from express license to implied license, and the bioequivalence test shall be put under record management (Article 29). We will abolish the certification system for the quality management of drug production and the certification system for the quality management of drug business (Article 10 and Article 16). The raw and auxiliary materials amended to be approved together with the pharmaceuticals (Article 31).

            (3) We will increase the establishment of a system of professional drug inspectors. In chapter 8 Drug Supervision, an additional clause is added to stipulate that the country shall establish a system of professional inspectors of drugs. The inspector shall possess the laws, regulations and professional knowledge of drugs and shall conduct inspection after passthe examination. The Pharmaceutical Supervisory and Administrative department under the State Council shall exercise hierarchical management over the professional inspectors of pharmaceuticals and establish incentive and restraint mechanisms such as assessment, salary and promotion (Article 64).

            (4) Implement the requirements for punishment. While modifying and perfecting the legal liability of the institute for non-clinical drug safety evaluation and research, the institute for clinical drug testing, the contract research organization, and the holder of the drug marketing license (Article 79, Article 94) in accordance with the obligation, the specific provisions of the penalty to the person shall be added. The authorities directly responsible and other persons directly responsible for the falsification of information and data and the revocation of licenses shall be prohibited from entering the industry within 10 years; A person who is sentenced to fixed-term imprisonment or above for a drug safety crime cannot engage in the development, production, marketing, import and export of a drug during his lifetime (Article 94). Drug marketing authorization holder, research units, producing enterprises, trading enterprises and medical institutions conducting illegal actions or gross negligence, bad or illegal behavior if the circumstances are serious, the nature or cause serious consequences, and raise other serious adverse social impact. The persons in charge who are directly responsible for the work and other persons who are directly responsible for the work shall be fined no less than 30 percent of their income from the work unit in the previous year and no more than 100 percent (Article 96).

            In order to ensure the implementation of the Reform Measures related to the innovation opinions as soon as possible, the Drug Administration law was amended partially, it does not involve the adjustment of the legal chapter structure, the definition and classification of drugs, the full chain and life cycle management of drugs, and the refinement of regulatory measures. Patent links, patent compensation and other exploration and pilot work will not be included temporarily;it will be reported to the NPC Standing Committee for authorization according to procedures. Next, the State Administration of Food and Drug administration will speed up the process of comprehensive revision of the Drug Administration law, which will be fully reflected in the draft revision, and strive to submit the draft revision to the Legislative Affairs office of the State Council before the end of the year.
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