[ NATIONAL · CN ]
A national authority with its own GMP and its own registration pathway, converging on ICH since accession.
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
ASIA-PACIFIC
The Drug Administration Law of the People’s Republic of China, in the revision adopted on 26 August 2019 and in force from 1 December 2019. That revision made a structural change practitioners still misread: it abolished the compulsory certification regimes for good manufacturing practice, good supply practice and good clinical practice. From 1 December 2019 the authority stopped accepting applications for, and stopped issuing, drug GMP and GSP certificates; applications already accepted before that date were completed under the previous provisions.
Through the licence and through continuous inspection, not through a certificate. Abolishing certification did not abolish the requirement. The Law obliges manufacturing and trading enterprises to establish and maintain quality management systems and to keep manufacturing and trading in conformity with legal requirements at all times, and it directs the national authority and its provincial counterparts to strengthen oversight through regular and continuing on-site inspection. Compliance became a state to be held rather than a status to be renewed.
WHAT TRANSFERS
The dossier converges; the inspection does not. China joined ICH in 2017, so technical requirements and much of the quality documentation have moved toward the other ICH regions and study data travels in a recognisable form. SPEQ has not decoded PIC/S participation for China, so an inspection outcome from a PIC/S authority is supporting context here rather than accepted currency, and overseas sites supplying the market can expect to be inspected by the Chinese authority itself.
A team used to demonstrating compliance by producing a current certificate has nothing to produce. The evidence is the state of the quality system at the moment an inspector arrives, and inspections are continuing rather than tied to a renewal cycle.
Oversight is shared between the national authority and its provincial counterparts. Which body arrives, and what it has seen at the site before, is part of the operating picture rather than an administrative detail.
Dossier format and study expectations moved substantially. Licensing, registration and the domestic accountability for an imported product did not, and that is where timelines are typically lost.
Registration for import requires an entity accountable within China. Approval elsewhere establishes nothing here on its own, and the domestic relationship is a commercial and regulatory decision that shapes everything after it.
No. The revised Drug Administration Law, in force from 1 December 2019, abolished compulsory GMP, GSP and GCP certification. From that date applications were no longer accepted and certificates were no longer issued, although applications accepted beforehand were completed under the previous provisions.
Continuous oversight. The Law requires manufacturing and trading enterprises to establish and maintain quality management systems and to remain in conformity with legal requirements at all times, and directs the national and provincial authorities to strengthen regular and continuing on-site inspection.
Partly. China joined ICH in 2017 and technical requirements have converged, so study data and much of the quality documentation are recognisable. Registration remains national, an imported product needs an accountable domestic party, and inspection is carried out by the Chinese authority rather than accepted from elsewhere.
ADOPTED, AT A PINNED VERSION
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about China: requirements still arrive through the authorities below, and the edition in force is theirs to state.
Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.