Chinese Drug Administration

Drug Administration Law (2019 Revision)

The Drug Administration Law of the People’s Republic of China (yàopǐn guǎnlǐ fǎ), substantially revised in 2019 and effective 1 December 2019, is the foundational legislative framework for pharmaceutical regulation. The 2019 revision introduced landmark changes including: a drug marketing authorisation holder (MAH) system; enhanced pharmacovigilance obligations; increased penalties for violations; and streamlined approval pathways for innovative drugs. The Law implements the principle of strictest supervision throughout the drug lifecycle, from research and development through manufacturing, distribution, and post-market monitoring.

The Law defines drugs broadly to include chemical pharmaceuticals, biological products, traditional Chinese medicines (TCM), and diagnostic reagents. It establishes the National Drug Administration (formerly the China Food and Drug Administration) as the primary regulator, now operating as the National Medical Products Administration (NMPA) under the State Administration for Market Regulation.

NMPA Regulation

The National Medical Products Administration (guójiā yàopǐn jiāndū guǎnlǐ jú) exercises comprehensive regulatory authority over drugs, medical devices, and cosmetics. The NMPA is responsible for: drug registration and approval; GMP (Good Manufacturing Practice) and GSP (Good Supply Practice) certification; pharmacovigilance oversight; drug inspection and testing; and enforcement of the Drug Administration Law.

The NMPA operates through a network of provincial and municipal drug administration bureaus that conduct inspections and enforce compliance locally. The NMPA also maintains the National Drug Standards (guójiā yàopǐn biāozhǔn), which establish quality specifications for pharmaceutical products, and the National Drug Repertory (guójiā jīběn yàowù), which lists essential medicines subject to government pricing and procurement controls.

Drug Registration (NDA and ANDA)

Drug registration in China follows a two-tier system: New Drug Applications (NDA; xīn yào shēnqǐng) and Abbreviated New Drug Applications (ANDA; fǎng zhì yào shēnqǐng). The Provisions for Drug Registration (2020) establish the application procedures, data requirements, and evaluation criteria. NDAs require comprehensive clinical trial data demonstrating safety, efficacy, and quality, while ANDAs require bioequivalence studies demonstrating equivalence to a reference listed drug.

The NMPA has implemented a series of reforms to accelerate drug approval, including: priority review for innovative drugs addressing unmet medical needs; conditional approval based on surrogate endpoints; acceptance of foreign clinical trial data under specified conditions; and a 60-day silent approval mechanism for certain categories. The Center for Drug Evaluation (CDE) within the NMPA conducts the scientific evaluation of registration applications. Approval timelines have been significantly reduced, with innovative drugs now approved within an average of 12–18 months.

GMP/GSP Certification

Drug manufacturers in China must obtain Good Manufacturing Practice (GMP; yàopǐn shēngchǎn zhìliàng guǎnlǐ guīfàn) certification from the NMPA. The GMP Certification Standards (2010 revision, aligned with WHO standards) establish requirements for: facility design and maintenance; equipment qualification; personnel training; raw material testing; production process control; quality control laboratory operations; and documentation practices.

Drug distributors must obtain Good Supply Practice (GSP; yàopǐn jīngyíng zhìliàng guǎnlǐ guīfàn) certification, which governs storage conditions, transportation controls, cold chain management, record-keeping, and recall procedures. Both GMP and GSP certifications are subject to periodic renewal and unannounced inspections. The NMPA maintains a Drug Quality Information Platform that publishes GMP/GSP compliance status and inspection results. Violations can result in suspension or revocation of certification, effectively preventing the manufacturer or distributor from operating.

Pharmacovigilance

The Pharmacovigilance System (yàopǐn ānquán jiāncè) was significantly strengthened by the 2019 Drug Administration Law and the Measures for the Administration of Drug Pharmacovigilance (2021). The system requires marketing authorisation holders to establish pharmacovigilance departments, designate qualified persons responsible for pharmacovigilance, and maintain systems for collecting, monitoring, and reporting adverse drug reactions (ADRs).

MAHs must submit periodic safety update reports (PSURs) to the NMPA, conduct risk management planning, and implement risk minimisation measures for drugs with identified safety concerns. The National ADR Monitoring Center collects and analyses ADR reports from healthcare institutions, manufacturers, and distributors. Healthcare professionals are required to report serious ADRs within 15 days. The NMPA may suspend marketing, impose additional labelling requirements, or order withdrawal of drugs based on pharmacovigilance findings.

Patent Linkage

China introduced a patent linkage system (yàopǐn zhuānlì liánjiē) effective 1 July 2021, under the Drug Administration Law and implementing regulations. The system establishes a mechanism for resolving patent disputes during the drug registration process. Generic applicants must make a patent declaration identifying relevant patents and stating whether they intend to challenge them. Branded drug companies may bring patent infringement actions within 45 days of receiving notice of a generic application.

The system includes a 9-month stay of approval period during which the NMPA may not approve a generic application if a patent infringement lawsuit is filed within the notification period. The system also provides for patent linkage early resolution through the courts, consistent with China’s commitments under the Phase One US-China Trade Agreement (2020). The SPC issued a judicial interpretation in 2021 establishing specialised procedures for patent linkage litigation, including expedited hearings and dedicated patent linkage case numbers.

TCM Regulation (Zhongyao)

Traditional Chinese Medicine (zhōngyào) regulation operates under the Traditional Chinese Medicine Law (2017) and the Drug Administration Law. TCM drugs are subject to a distinct regulatory pathway that recognises their unique characteristics, including the use of materia medica with complex multi-component compositions and long historical use. The TCM registration pathway may accept historical clinical evidence in lieu of conventional clinical trials for well-established TCM preparations.

The NMPA maintains a TCM Standards System that includes: the Pharmacopoeia of the People’s Republic of China (TCM volume); provincial TCM processing standards; and enterprise quality standards. TCM manufacturers must comply with GMP requirements adapted for TCM production. The regulatory framework also addresses TCM decoction pieces (yinpian), Chinese patent medicines (zhongchengyao), and TCM health products (baojianpin). The State Administration of Traditional Chinese Medicine coordinates TCM policy development and promotes the integration of TCM into the national healthcare system.