2. Compared with the 2007 version of the Measures, many new ideas and system designs have been introduced: First, the new reform measures introduced by the reform of drug evaluation and approval system in recent years have been solidified, and the newly revised Measures reflect some core new systems in drug supervision. For example, the new system of drug marketing license holder system, implied license of drug clinical trials, priority review and approval, related review and approval of raw and auxiliary packages and preparations, communication and expert consultation. The second is to further optimize the examination and approval procedures. For example, the drug registration inspection can be started before acceptance, and the on-site inspection of drug registration and the pre-market good manufacturing practice inspection can be implemented simultaneously.
3. The revised Measures enrich the content of encouraging drug research and innovation, so as to improve the accessibility of drugs: First, in combination with the development of China's pharmaceutical industry and the actual needs of clinical treatment, referring to international experience, a chapter on accelerating drug listing and registration procedures has been added, and four accelerated channels, namely breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval, have been set up, and the scope, procedures and support policy requirements of each channel have been clarified. Second, drugs in short supply, drugs for children, drugs for rare diseases, drugs for major infectious diseases, vaccines urgently needed for disease prevention and control, and innovative vaccines listed in the Drug Administration Law, the Vaccine Administration Law and the the State Council document will be clearly included in the scope of accelerating listing and registration.
legal ground
Article 1 of the Measures for the Administration of Drug Registration is to standardize drug registration and ensure the safety, effectiveness and controllable quality of drugs. According to the Drug Administration Law of People's Republic of China (PRC) (hereinafter referred to as the Drug Administration Law), the Chinese Medicine Law of People's Republic of China (PRC), the Vaccine Administration Law of People's Republic of China (PRC) (hereinafter referred to as the Vaccine Administration Law) and the Vaccine Administration Law of People's Republic of China (PRC).
Article 2 These Measures shall apply to drug research, registration, supervision and management activities aimed at drug listing in People's Republic of China (PRC).
Article 3 Drug registration refers to the activities in which an applicant for drug registration (hereinafter referred to as the applicant) submits an application for drug clinical trial, an application for drug marketing license, an application for re-registration and other supplementary applications in accordance with legal procedures and relevant requirements, and the drug supervision and administration department conducts a safety, effectiveness and quality controllability review according to laws and regulations and existing scientific knowledge, and decides whether to approve the application.
After obtaining the drug registration certificate, the applicant is the holder of the drug marketing license (hereinafter referred to as the holder).
Article 4 Drug registration shall be managed according to the classification of traditional Chinese medicines, chemical medicines and biological products.
The registration of traditional Chinese medicines is classified according to innovative traditional Chinese medicines, improved new traditional Chinese medicines, compound preparations of ancient classic Chinese medicines and medicines with the same name.
The registration of chemicals is classified according to innovative drugs, improved new drugs and generic drugs.
The registration of biological products is classified according to innovative drugs, improved drugs and marketed biological products (including similar drugs).
The detailed classification of traditional Chinese medicines, chemical medicines and biological products and the corresponding application data requirements shall be formulated by the State Administration of Pharmaceutical Products according to the product characteristics, innovation degree and evaluation management needs of registered drugs, and shall be announced to the public.
The application for registration of drugs produced overseas shall be implemented in accordance with the detailed classification of drugs and the corresponding application materials.
Article 5 The State Administration of Pharmaceutical Products shall be in charge of the administration of drug registration throughout the country, and shall be responsible for establishing the working system and system of drug registration administration, formulating the management norms of drug registration, and organizing the examination and approval of drug registration and relevant supervision and administration according to law. The Drug Evaluation Center of the State Administration of Pharmaceutical Products (hereinafter referred to as the evaluation center) is responsible for the evaluation of the applications for clinical trials, marketing licenses, supplements and re-registration of drugs produced overseas. China Food and Drug Inspection Institute (hereinafter referred to as China Pharmaceutical Academy), State Pharmacopoeia Committee (hereinafter referred to as Pharmacopoeia Committee), Food and Drug Inspection Center of State Pharmaceutical Products Administration (hereinafter referred to as Drug Inspection Center), Drug Evaluation Center of State Pharmaceutical Products Administration (hereinafter referred to as Drug Evaluation Center), Administrative Matters Acceptance Service and Complaint Reporting Center of State Pharmaceutical Products Administration, and Information Center of State Pharmaceutical Products Administration (hereinafter referred to as Information Center). Other pharmaceutical professional and technical institutions undertake the related work such as drug registration inspection, generic name approval, verification, monitoring and evaluation, certificate issuance and corresponding information construction and management required for drug registration management according to law.