GMP Auditing & Consulting LLC — Reference Docket

NMPA GMP Index (China)

China's Good Manufacturing Practice for Drugs, its device GMP framework, and related law, organized by product category — every entry links to its official English-language source. Search by keyword or regulation number.

— entries indexed Device GMP revision effective 1 Nov 2026

Overall Index

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A GMP Auditing & Consulting LLC resource.

This library maps China's drug and device GMP framework — administered by the National Medical Products Administration (NMPA) — to the product categories manufacturers build against. China's regulatory structure diverges from FDA/EU/PIC/S/WHO in a few important ways worth flagging: it uses a three-class device system like FDA rather than Canada/Brazil's four-class model; it regulates vaccines under a dedicated Vaccine Administration Law enacted after the 2018 Changchun Changsheng incident, reflecting one of the strictest vaccine-specific legal regimes globally; and its device GMP was substantially revised in November 2025, with the new text taking effect 1 November 2026 — a transition worth tracking closely if you have device clients sourcing from or manufacturing in China. All citations here link to NMPA's official English-language portal (english.nmpa.gov.cn) where a specific page was confirmed, and to the portal homepage otherwise, since not every Chinese-language regulation has a stable English deep link. We review this library periodically as NMPA continues its regulatory modernization program. Corrections welcome at gmpauditingandconsultingllc@gmail.com. This index is a navigational aid, not legal or regulatory advice.