Full Translation of China Drug Registration Regulation
By Tigermed Medical Translation Team and Registration Team
This is the full translation of newly updated Drug Registration Regulation, which was officially published by China’s National Medical Products Administration (NMPA) on Marhc 30, 2020 and will be effective on July 1, 2020. This document was translated by Tigermed Medical Translation Team and Registration Team and is for the purpose of research & learning reference only.
Drug Registration Regulation
(Order No. 27 of the State Administration for Market Regulation, Issued on 22 Jan 2020)
Article 1 This Regulation is formulated for the purposes of regulating drug registration and ensuring the safety, efficacy and quality of drugs in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Drug Administration Law), Law of the People’s Republic of China on Traditional Chinese Medicine, Law of the People’s Republic of China on Vaccine Management (hereinafter referred to as the Law on Vaccine Management), Administrative Permission Law of the People’s Republic of China, the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China and other laws and administrative regulations.
Article 2 This Regulation is applicable to the research and development, registration, supervision and administration of pharmaceuticals with the purpose of marketing within the territory of the People’s Republic of China.
Article 3 Drug Registration refers to the activity in which the registration applicant (hereinafter referred to as “Applicant”) files applications, such as drug clinical trial application, drug marketing license application, re-registration application and supplementary application, in accordance with the official procedures and relevant requirements, and the drug regulatory authorities review the safety, efficacy and quality of the drugs based on laws and regulations, and current scientific cognition, and decide whether or not to approve such an application.
The Applicant obtaining the drug registration certificate becomes the marketing authorization holder (hereinafter referred to as the MAH).
Article 4 Regulatory Affairs are administered by classified registration for Traditional Chinese Medicine (TCM), chemical drugs, biological products and other pharmaceutical products.
Categories of TCM registration include, but are not limited to innovative TCM, modified new TCM, ancient TCM compound preparations and medicine of the same name and prescription.
Categories of chemical drugs include, but are not limited to innovative drugs, modified new drugs and generics.
Categories of biological products include, but are not limited to innovative products, modified new products and marketed products (including biosimilars).
National Medical Products Administration (NMPA) will stipulate the specified classifications of TCM, chemical drugs and biological products and requirements for their application dossiers, in accordance with the product characteristics, innovativeness and the need for review and management, and make them public.
Registration applications for drugs manufactured abroad shall be submitted as per specified classifications with required application dossiers.
Article 5 The NMPA is in charge of drug registration nationwide, and responsible for establishing drug registration administration system, formulating standards for drug registration administration, and organizing review and approval of drug registration as well as relevant supervision and administration in accordance with laws. The Center for Drug Evaluation of NMPA (CDE) is responsible for the evaluation of drug clinical trial applications, drug marketing license applications, supplementary applications and re-registration applications for drugs manufactured abroad. National Institutes for Food and Drug Control (hereinafter referred to as NIFDC), Chinese Pharmacopoeia Commission (hereinafter referred to as ChP Commission), Center for Food and Drug Inspection of NMPA (hereinafter referred to as CFDI), Center for Drug Reevaluation of NMPA (hereinafter referred to as CDR), Center for Administrative Services and Complaints & Reports of NMPA, Information Center of NMPA (hereinafter referred to Information Center) and other technical institutions assume the drug registration inspection, approval of generic names, inspection, monitoring and evaluation, certificates production and delivery, and other work related to information construction and administration that are necessary to manage the drug registration in accordance with laws.
Article 6 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of registration for the following drugs within their own administrative regions:
(I) Acceptance, review and approval of re-registration application of domestic drugs;
(II) Administration of filing and reporting of post-marketing change;
(III) Organizing daily supervision and punishment of illegal acts of non-clinical safety evaluation institution and clinical trial institution;
(IV) Participation in drug registration inspection and testing organized by the NMPA;
(V) Relevant regulatory affairs designated by NMPA.
A specialized pharmaceutical technical institution established or designated by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall undertake the review, inspection, verification, monitoring and evaluation work necessary for the implementation of the supervision and administration of pharmaceuticals in accordance with the law.
Article 7 The administration of drug registration shall follow the principles of openness, fairness and justice, be clinical value-based, encourage the research and development of new drugs and actively promote the development of generic drugs.
NMPA shall continuously promote the reform of the review and approval system, optimize the review and approval process, improve the efficiency of review and approval, and establish a review-based drug registration administration system supported by inspection, verification, monitoring and evaluation.