An overseas partner may reasonably ask for a “China GMP certificate.” The right response is not a vague assurance or an old certificate. It is a clear explanation of China’s current inspection-led framework, followed by a document request that matches the product, manufacturing site, market and proposed cooperation.
1. The short answer
China’s removal of the separate drug GMP-certificate process did not remove GMP requirements. NMPA’s 2019 announcement says that, from 1 December 2019, drug GMP and GSP certifications were cancelled and the corresponding certificates would no longer be issued. Current diligence should therefore focus on the legally relevant manufacturing licence, the applicable inspection and compliance context, and evidence that is specific to the proposed product and route. [1]
2. What changed in 2019—and what did not
The change was a change in how evidence is issued and regulated, not permission to manufacture outside GMP. NMPA’s current drug-manufacturing provisions require manufacture to comply with GMP. Its 2026 contract-manufacturing announcement likewise requires contract manufacturers to maintain a continuously effective quality-management system and strictly comply with drug GMP. [4] A historic “GMP certificate” can therefore be a dated record, but it is not by itself the right present-tense credential.
3. What an overseas partner should verify now
Ask for a controlled, product-specific evidence set rather than a generic certificate claim. The appropriate set normally depends on the product, dosage form, market and legal role. It may include the relevant Drug Manufacturing License scope; a current explanation of the site, workshop and production-line fit; the applicable inspection or quality-compliance context; and, after proper confidentiality arrangements, product-specific technical, quality and regulatory materials. NMPA’s export rules link GMP-compliance inspection to the site, scope, workshop and production line recorded in the Drug Manufacturing License. [3]
4. What a CoPP can—and cannot—show
A Certificate of a Pharmaceutical Product (CoPP) is not a company-wide quality certificate. Under NMPA’s export-certificate framework, it is a product-specific export document. The current provisions took effect on 1 January 2026; NMPA says the CoPP template follows the WHO’s 2021 recommended format and that its validity period is standardized at three years. [2] [3] It can be useful evidence for the identified product or dosage form, but it does not itself prove that a separate product, site, market, price, schedule or CMO/CDMO project is approved or available.
5. A practical verification sequence
Begin with five disciplined questions, then move to a controlled project review.
6. Additional care for contract manufacturing
For China contract manufacturing, evidence should be paired with governance. NMPA’s 2026 announcement requires a prospective contract manufacturer to evaluate the MAH, product risks, technical-transfer feasibility and co-line feasibility before signing the contract-manufacturing and quality agreements. It also expects the agreements to define access, communication and quality responsibilities. [4] A certificate or licence cannot substitute for this product-specific evaluation.
Confirm the exact legal entity, proposed role and relevant licensed manufacturing scope.
Match product, dosage form, strength, market, site, workshop and production line before treating any evidence as relevant.
Where a CoPP is requested, confirm its issuing authority, date, product scope and purpose—without extrapolating it to unrelated projects.
Discuss only non-confidential project facts first: dosage form, target market, stage, requested model and timing.
Use appropriate confidentiality arrangements for technical, quality, regulatory, capacity and commercial assessment.
Frequently asked questions
Does the absence of a current China GMP certificate mean that no GMP requirements apply?
No. NMPA cancelled the separate certification process in 2019; drug manufacturing remains subject to GMP requirements and regulatory oversight.
Does a CoPP prove a manufacturer is suitable for every project?
No. A CoPP is product-specific. Site fit, technical transfer, quality systems, capacity, registration strategy and commercial terms require a separate assessment.
Can a CoPP be relevant where a product is not marketed in China?
NMPA’s current export framework describes circumstances in which export certificates may be applied for regardless of domestic marketing status. Eligibility and evidence must be confirmed for the individual product with the responsible authority.
What should be shared in a first inquiry?
Only non-confidential facts such as product type, dosage form, target market, project stage, requested cooperation model and intended timing. Do not send patient information, formulas, full dossiers or trade secrets at first contact.
Does this page claim that Hainan Hailing holds a CoPP or a current GMP certificate?
No. This is a general regulatory explanation. It does not claim a Hainan Hailing CoPP, a current approval, supply, capacity, site fit or project acceptance.
Authoritative sources
- NMPA — Implementation of the Drug Administration Law (2019 No. 103)
- NMPA — Exported pharmaceutical products inspection and export-certificate provisions (2025 No. 113)
- NMPA — Policy interpretation of the export-certificate provisions
- NMPA — Contract manufacturing supervision announcement (2025 No. 134)
- NMPA — Certificate of a Pharmaceutical Product database entry point
This article is for general business discussion. It is not legal, regulatory or medical advice. Requirements should be confirmed with the responsible parties and applicable authorities.