EU market entry · China
China is the EU's largest supplier of many starting materials and active substances. There is no mutual recognition agreement: every batch of a finished product is tested in the EU, and every active substance imported into the EU in its own right needs a written confirmation from the Chinese authority. A&O reviews the documents, imports with partners, tests and releases.
The route of a batch from China
China
Manufacture to EU GMP Required
For active substances under Part II of the EU GMP Guide.
China
Written confirmation Required
For importing the API, from the medical products administration of the province where the site is located.
China
CEP or ASMF Required
For the marketing authorisation application, not for the import.
EU
Supplier qualification Handled by A&O
Audit and document review before the API is used.
EU
Manufacture of the medicine Destination
The API goes into manufacturing in the EU.
Three pieces of evidence that do not replace one another.
of the organic chemicals the EU sourced from outside in 2025 came from China. They include many starting materials and active substances.
Eurostat Comext, HS 29of EU antibiotic imports came from China in 2025, just ahead of Switzerland.
Eurostat Comext, HS 2941of finished pharmaceutical products imported into the EU from China in 2025, fourth among countries of origin.
Eurostat Comext, HS 30In short
An active substance from China needs three things: manufacture to EU GMP, a written confirmation from the medical products administration of the province where the site is located, and, for the marketing authorisation, an EDQM CEP or, if no CEP is available, an Active Substance Master File (ASMF, formerly Drug Master File). The EU manufacturer of the medicine must also qualify the supplier itself.
Finished medicinal products from China need the manufacturer's GMP certificate, import under an import authorisation, retesting of every batch in the EU and certification by a Qualified Person. No written confirmation is needed for them, even if the API comes from China. There is no agreement with China that waives retesting.
Reviewed on 23 October 2026 by
Dr. Olaf Mundszinger
Qualified Person (QP) under § 14 AMG
Regulations checked against the original sources on 19 October 2026
Where the EU sources its medicinal products
For finished medicines, China ranks fourth. For organic chemicals and antibiotics, it is the EU's largest supplier.
EU imports of pharmaceutical products (HS 30) from outside the EU, 2025. Source: Eurostat Comext, as of October 2026
Three documents
Three documents for APIs from China are often confused. Each proves something different, and none replaces another. Hover over the circles.
For importing the API, the GMP certificate and written confirmation count; for the marketing authorisation, the CEP.
How it works
This is the route when an EU manufacturer sources an API from China for the first time, or a finished product from China enters the EU.
We check EU GMP status, written confirmation, CEP and quality agreement for completeness and validity.
Where needed, we audit the site against EU GMP as part of supplier qualification.
A partner physically imports finished products, under A&O's import authorisation and that of our partner.
Our GMP-certified laboratory fully tests every batch against the marketing authorisation.
Our Qualified Person certifies the batch. It can then be placed on the EU market.
Route check
A few clicks and you will see your route into the EU market. It does not replace advice, but it shows what we should talk about.
The legal framework
Imported active substances need a written confirmation from the authority of the exporting country. China is not on the list of exempt countries. No confirmation is needed for an imported finished product.
View source ↗In China, the medical products administration of the province where the site is located issues the confirmation for APIs exported to the EU. It is valid for three years.
View source ↗The written confirmation is still required after an EDQM inspection; the two are independent (question 30). It does not apply to APIs contained in an imported finished product (question 10).
View source ↗A CEP shows that the quality of an active substance is suitably controlled by the European Pharmacopoeia monograph. The EDQM also inspects sites in China for this.
View source ↗Every batch of a medicinal product from a third country is fully analysed in the EU. There is no agreement with China that waives this.
View source ↗What A&O takes on
Frequently asked questions
The medical products administration of the province where the site is located, not NMPA headquarters in Beijing. The basis is NMPA Announcement 2025 No. 113. The confirmation is valid for three years.
No. The written confirmation is only needed when the API itself is imported into the EU. For a finished product from China, the manufacturer's GMP certificate is what counts, even if the API comes from China. The API's CEP belongs in the marketing authorisation application, not the import.
No. The CEP shows the quality of the API under the European Pharmacopoeia; the written confirmation shows supervision by the Chinese authority. According to the European Commission's Q&A, the confirmation is required even after an EDQM inspection.
Yes, every batch of a finished product. There is no mutual recognition agreement with China. A&O handles retesting in its own laboratory in Itzehoe and certification by the Qualified Person.
According to a 2021 European Commission study cited by the Council of the EU, 80 per cent of imported pharmaceutical ingredients come from five countries, 45 per cent from China alone. Eurostat shows China as the EU's largest supplier of organic chemicals and antibiotics.
For Hong Kong, yes: it is not on the EU list. Taiwan has been on the Article 111b list since 2023, so APIs from there need no written confirmation. The EU notes that this listing does not reflect any official position on the legal status of Taiwan.
Other countries of origin
Document review, audit, import, retesting and release from one provider. In English or German.
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