CN · Centre for Drug Evaluation

NMPA

National Medical Products Administration

11 documents in the Library — regulations, inspection procedures, guidance, Q&As, and reflection papers.

§ 01 — Agency portal

AGENCY PORTAL · NMPA NMPA Centre for Drug Evaluation — GCP Resources The agency's own GCP hub — navigation and resources beyond the documents catalogued below.

opens on nmpa.gov.cn ↗

§ 02 — Documents

NMPA NMPA Announcement on Adoption of ICH E6(R3) Good Clinical Practice Guideline NEW NMPA Announcement No. 125 of 2025 NOTICE 2025 HTML · — NMPA Guiding Principles for Computerized Systems and Electronic Data in Drug Clinical Trials (Draft for Comment) NEW Draft CDE, November 2025 GUIDANCE 2025 PDF · — NMPA Good Clinical Practice for Drugs (2025 Revision — Draft for Comments) NEW Draft REGULATION 2025 DOCX · — NMPA Inspection Checkpoints and Judging Principles for Drug Clinical Trials NEW INSPECTION PROCEDURE 2025 PDF · — NMPA Technical Guidelines for Evaluation of the Relevance of Adverse Events in Drug Clinical Trials NEW No. 31 of 2024 GUIDANCE 2024 PDF · ~500 KB NMPA CDE Guidance on Centralised Monitoring GUIDANCE 2024 LINK · — NMPA Work Procedures for Drug Registration Inspection (Trial) NEW CFDI No. 30 of 2021, Attachment 1 INSPECTION PROCEDURE 2021 PDF · — NMPA E6(R3) GCP Guideline Implementation Recommendations CDE, August 2025 GUIDANCE 2025 PDF · 820 KB NMPA Good Clinical Practice for Drug Clinical Trials (2020 Revision) No. 57 REGULATION 2020 PDF · 1.4 MB NMPA Provisions for Drug Registration REGULATION 2020 LINK · — NMPA Drug Administration Law of the People's Republic of China (2019 Revision) NEW Presidential Order No. 31 REGULATION 2019 HTML · —