Drug registration, production and operation 3 documents for comments, new drug market speed up again!

On August 26, 2019, the drug administration law was deliberated and adopted at the 12th meeting of the 13th National People's Congress Standing Committee, and shall come into force as of December 1, 2019 In order to establish a scientific and strict drug supervision and management system and ensure the effective implementation of the drug administration law, the State Drug Administration organized the drafting of measures for the administration of drug registration (Draft for comments), measures for the supervision and management of drug production (Draft for comments), measures for the supervision and management of drug operation (Draft for comments), which passed the State Drug Administration on September 30, 2019 The website of the Bureau solicits opinions from the public According to the opinions and suggestions of all parties, the State Food and Drug Administration organized further revision and improvement of the three regulations, and again solicited opinions from the public through the legal information network of the Chinese government All relevant units or individuals are welcome to put forward modification opinions and give feedback before November 14, 2019 The public can log on the legal information network of the Chinese government (website: http://www.chinalaw.gov.cn) and enter the "legislative opinion collection" column of the main menu on the home page to put forward opinions On October 15, 2019, the State Administration of market supervision and Administration recommended reading: drug registration measures are revised, and traditional Chinese medicine generic drugs will become the first chapter of the administrative measures for the registration of historical drugs (Draft for comments), general provisions, Article 1 (legal basis) to regulate drug registration, To ensure the safety, effectiveness and controllable quality of drugs, according to the drug administration law of the people's Republic of China (hereinafter referred to as the drug administration law), the Chinese medicine law of the people's Republic of China, the vaccine administration law of the people's Republic of China (hereinafter referred to as the vaccine administration law), the administrative license law of the people's Republic of China (hereinafter referred to as the administrative license law), and the Chinese people These measures are formulated in accordance with the regulations for the implementation of the drug administration law of the people's Republic of China (hereinafter referred to as the regulations for the implementation of the drug administration law) Article 2 (scope of application) these measures are applicable to the research and development, registration, supervision and administration of drugs within the territory of the people's Republic of China for the purpose of listing drugs Article 3 (definition of drug registration) drug registration refers to the process in which the applicant submits an application for drug registration in accordance with legal procedures and relevant requirements, and the drug regulatory department reviews the safety, effectiveness and quality controllability based on the existing laws and regulations and scientific cognition, and decides whether to approve the application Article 4 (drug registration matters) drug registration matters, including drug clinical trial application, drug listing registration application, drug supplement application, drug re registration application and other licensing matters, as well as other filing or reporting matters Article 5 (drug registration category) drug registration categories shall be classified according to traditional Chinese medicine, chemical drugs, biological products, etc Registration and classification of traditional Chinese medicine: innovative medicine, improved new medicine, ancient classic traditional Chinese medicine compound preparation, the same name and the same prescription, etc Registration and classification of chemical drugs: innovative drugs, improved new drugs, generic drugs, chemicals that have been listed overseas but not listed in China, etc Registration classification of biological products: innovative biological products, improved biological products, domestic listed biological products (including biological similar drugs and domestic listed biological products not under the management of biological similar drugs), overseas listed domestic unlisted biological products, etc The State Drug Administration (hereinafter referred to as the State Administration) shall, in accordance with the product characteristics, innovation level and evaluation management needs of registered drugs, organize the formulation and release of detailed classification of various drugs and corresponding application data requirements Article 6 the State Administration is in charge of the national drug registration administration, is responsible for establishing the drug registration management system and system, organizing the drug registration review and approval as well as the related supervision and management according to law The National Bureau shall establish a technical evaluation system with evaluation as the leading and inspection as the supporting The drug evaluation center of the State Administration is responsible for the acceptance and evaluation of drug registration matters such as drug clinical trial application, drug listing registration application, drug supplement application and re registration application of drugs produced abroad and listed in China, and makes administrative licensing decisions in the name of the State Administration Food and drug examination and inspection center of the State Administration (hereinafter referred to as the drug examination center of the State Administration), China food and drug inspection and Research Institute (hereinafter referred to as the Chinese Academy of inspection), National Pharmacopoeia Committee (hereinafter referred to as the Pharmacopoeia Committee), administrative matter acceptance service and complaint reporting center of the State Administration (hereinafter referred to as the acceptance and reporting center of the State Administration), drug evaluation center of the State Administration, and information of the State Administration The information center and other pharmaceutical professional and technical institutions shall be responsible for the inspection, inspection, standard formulation and revision, certificate preparation and delivery, monitoring and evaluation of drug registration as well as the construction and management of corresponding information systems or platforms required for the implementation of drug registration management in accordance with the law Article 7 the drug administration of the people's Government of a province, autonomous region or municipality directly under the central government (hereinafter referred to as the provincial administration) shall be responsible for the administration of drug registration within its own administrative region: (1) the acceptance, examination and approval of drug re registration; (2) the administration of the filing and reporting of changes after the drug listing; （3） Daily supervision of drug non clinical safety evaluation and research institutions and drug clinical trial institutions as well as investigation and punishment of illegal behaviors; (4) participation in drug registration inspection and inspection organized by the State Administration; (5) other matters related to drug registration entrusted by the State Administration Article 8 the administration of drug registration shall follow the principles of openness, fairness and justice, and be guided by clinical value, encourage the research and development of new drugs, optimize the review and approval process, and improve the efficiency of review and approval Chapter II Basic Systems and requirements Article 9 (regulatory system) in drug development and registration activities, laws, regulations, rules, standards and specifications shall be observed to ensure the authenticity, accuracy, integrity and traceability of the whole process of information Refer to the current technical guidelines and carry out according to the procedures If the applicant adopts other evaluation methods and technologies, it shall prove its scientificity and applicability Technical institutions such as the drug evaluation center of the State Administration shall, in accordance with scientific progress and work needs, formulate technical guidelines and procedures, regularly formulate and revise work plans, and publicize them to the public Article 10 the applicant shall be an enterprise or drug research and development institution that can bear corresponding legal liabilities Where the applicant is an overseas enterprise or a pharmaceutical research and development institution, the matter shall be handled by its office in China or by its entrusted agency in China Article 11 before applying for drug listing registration, the applicant shall complete the research work of pharmacy, pharmacology and toxicology, and corresponding clinical trials of drugs Among them, drug non clinical safety evaluation research shall be carried out in institutions certified by drug non clinical research quality management standard, and shall comply with drug non clinical research quality management standard; drug clinical test shall be approved by drug evaluation center of State Administration, chemical generic drug bioequivalence test shall be reported to drug evaluation center of State Administration for filing, and drug on file The clinical trial institutions shall carry out and comply with the quality management specification for clinical trials of drugs In applying for drug registration, authentic, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of drugs The use of overseas research materials and data to support drug registration on the market shall come from research institutions or laboratories that conform to the prevailing principles of ICH, and meet the requirements of China's drug registration regulations and corresponding guiding principles Article 12 in case of any change, addition or cancellation of the original drug registration approval, filing or reporting items or contents, the applicant shall fully study and verify the drug change, fully evaluate the possible impact of the change on the safety, effectiveness and quality controllability of the drug, and make a supplementary application, filing or report according to the procedures after determining the type of change Article 13 the period of validity of the drug listing approval certificate is 5 years The holder shall continuously guarantee the safety, effectiveness and quality controllability of the drug and apply for drug re registration 6 months before the expiration of the period of validity The Provincial Bureau of the place where the holder is located shall be responsible for the re registration of drugs produced within the territory of China, and the drug evaluation center of the State Administration shall be responsible for the re registration of drugs produced within the territory of China Article 14 support the innovation of drugs guided by clinical value and establish the system of accelerating the registration of drugs on the market For the qualified drug registration application, the applicant can apply to enter the breakthrough treatment drug procedure, conditional approval procedure, priority review and approval procedure and special approval procedure During the drug development and registration process, policy support such as technical guidance, whole process communication, priority allocation of resources, shortening the review time limit, etc shall be provided Article 15 a system for examination and approval of Association review shall be established When approving drugs, the chemical APIs shall be reviewed and approved together, and the relevant auxiliary materials, packaging materials and containers in direct contact with drugs shall be reviewed and approved together Among them, the chemical APIs shall be examined and approved at the time of drug preparation examination and approval; the chemical APIs of domestic listed drugs may apply for independent examination and approval Establish the information registration platform for chemical raw materials, related auxiliary materials and packaging materials and containers (hereinafter referred to as the original auxiliary package) that directly contact with drugs, register the information of the original auxiliary package, and associate it in the drug preparation evaluation At the same time, the chemical API shall be issued with the drug approval certificate and the approved production process and quality standard Article 16 optimize the registration of over-the-counter drugs According to the characteristics of over-the-counter drugs, the drug evaluation center of the State Administration formulates technical guidelines and procedures related to the listing and registration of over-the-counter drugs, and publishes them to the public The listed prescription drugs and over-the-counter drugs can be exchanged after being approved for marketing The drug evaluation center of the State Administration formulates relevant technical guidelines and procedures, and publishes them to the public Article 17 a communication system shall be established Before the application for drug clinical trial, the key stage in the process of drug clinical trial and the application for drug listing registration, the applicant can apply to the drug review center and other technical institutions of the State Administration for communication and exchange on major issues; during the drug registration process, the drug review center and other technical institutions of the State Administration can organize communication and exchange with the applicant according to the work needs The procedures, requirements and time limit for communication and exchange shall be formulated by the drug evaluation center of the State Administration and other technical institutions according to their functions and made public to the public Article 18 an expert consultation system shall be established Technical institutions such as drug evaluation center of the state administration actively listen to experts' opinions in the process of evaluation, inspection, inspection, standard preparation and revision, etc., and give full play to the technical support role of experts Article 19 a catalogue system for listed drugs shall be established The list of drugs on the market contains the approved drugs such as innovative drugs, improved new drugs and generic drugs, and contains the name, active ingredients, dosage forms, specifications, reference preparations, holders and other relevant information of the drugs, which shall be made public to the public The procedures and requirements for the collection and loading of the list of listed drugs shall be formulated by the drug evaluation center of the State Administration and published to the public Article 20 support the inheritance and innovation of traditional Chinese medicine Establish and improve the registration management system and technical evaluation system in line with the characteristics of traditional Chinese medicine, and combine the traditional advantages of traditional Chinese medicine with the scientific requirements of drug research and development