Supplying Medicines and Supplements to China

For many buyers, China is first a place to source from. Chinese plants make a wide range of APIs, intermediates, vitamins and amino acids, and many offer contract manufacturing. China stopped issuing drug GMP certificates in December 2019 and relies on inspections instead. So ask for the manufacturing licence, recent inspection results and any EDQM, FDA or EU inspection history. Provincial regulators issue export certificates in WHO format and written confirmations for APIs going to the EU.

Selling into China starts with NMPA, an ICH member since 2017, so a CTD dossier is the base. An overseas company can hold the approval, but it must appoint a China-based company to act for it and share liability. Imported medicines enter through designated ports and are checked there. After approval, national volume-based procurement shapes generic prices, and yearly negotiations decide what goes on the reimbursement list.

China at a glance

How to supply medicines to China

1. Appoint your China-based agent. An overseas marketing authorisation holder must appoint an enterprise legal person in mainland China to carry out its duties, and the two share liability. Its details go on the package insert, so choose carefully and agree roles in writing. Our dossier and registration service can help you plan this.
2. Prepare the dossier and the API file. NMPA works to ICH standards, so build on the CTD. APIs, excipients and packaging are registered on the CDE platform and reviewed together with your product. See CEP vs DMF vs ASMF and our ICH stability guide.
3. Get approved and be ready for inspection. NMPA issues a drug registration certificate, valid for five years. Breakthrough therapy, conditional approval and priority review can shorten the path. Your China-based agent also helps when NMPA inspects overseas plants, so keep your quality documents current.
4. Import through a designated port and plan for pricing. Imported medicines must enter through ports approved for drug imports. The importer files with the port's drug regulator, which issues the import note customs needs and arranges sampling and testing. Established generics may then be included in national volume-based procurement, and new medicines can apply for the reimbursement list. See our tender supply service.

For an urgent clinical need, a medical institution can import a small quantity of an unapproved medicine with approval from NMPA or an authorised provincial government, for use within designated institutions. Hospitals in the Boao Lecheng pilot zone apply to the Hainan government (vaccines excluded), and designated hospitals in the Greater Bay Area can use urgently needed medicines marketed in Hong Kong or Macao with Guangdong's approval. See named-patient and special import and government tender supply.

Sourcing from China

• APIs and master files. Chinese API makers may hold a CEP from EDQM or a US DMF with FDA, which FDA reviews with each application rather than approving on its own. Ask which file supports your market, and who holds it. Our DMF guide, CEP vs DMF vs ASMF and API sourcing service cover what to ask.
• GMP inspections and what replaces GMP certificates. China cancelled drug GMP certificates from 1 December 2019; plants must still follow GMP and are inspected. Ask for the drug manufacturing licence, recent inspection results and any EDQM, FDA or EU reports. NMPA applied to join PIC/S in 2023 but is not yet a member. See how to verify suppliers.
• Contract manufacturing. Chinese plants with a drug manufacturing licence make products for overseas holders, and export certificates can cover products not approved in China. Check which lines the licence names and agree a quality agreement before you start. See our CDMO guide and white-label manufacturing.
• Export documents. Provincial regulators issue the drug export sales certificate in the WHO certificate of pharmaceutical product format, valid three years, and written confirmations for APIs exported to the EU. Narcotic and psychotropic APIs need an NMPA export licence and an import authorisation in the destination country. See our CoPP guide and documentation pack.

Supplements

Supplements are sold in China as health foods (保健食品), regulated by SAMR. Products using ingredients outside SAMR's ingredient catalogue, and most first-time imports, need full SAMR registration through a representative office or agent in China, while first-time imports of vitamin and mineral supplements are filed with SAMR, with the overseas maker as filer. Claimed functions must be on SAMR's approved list and the label must say the product cannot replace medicines, so keep disease claims off the pack. We help brands get supplements made under their own label by GMP-certified contract manufacturers: see nutraceutical private label.

What buyers look for in China

Buyers who come to China most often look for APIs and intermediates, vitamins and amino acids such as vitamin C and creatine, and contract manufacturing for finished medicines and supplements.

Chinese suppliers and regulators use Simplified Chinese terms: 原料药 (API), 中间体 (intermediates), 药用辅料 (excipients), 药品注册证书 (drug registration certificate), 药品生产许可证 (drug manufacturing licence), 药品出口销售证明 (drug export sales certificate) and 保健食品 (health food). On the market side you will also hear 带量采购 (volume-based procurement) and 国家医保药品目录 (National Reimbursement Drug List).

How importers, distributors and manufacturers search for China

Importers and distributors usually search in English, with terms such as “API manufacturer China”, “CEP”, “US DMF”, “GMP API supplier” and “contract manufacturing China”, often paired with the generic name of the molecule.

Supplements we can help you make

Medicines and APIs buyers often source from China include antibiotics, heparin-type products, statins and everyday pain relievers. Some examples we list:

Documents to ask your supplier for

• A Certificate of a Pharmaceutical Product (CoPP) in WHO format.
• The plant's GMP evidence, such as a WHO-GMP, EU-GMP or PIC/S certificate, plus any inspection by your regulator.
• The registration dossier (CTD or ACTD), with bioequivalence data for generics where required.
• Stability data for hot climates.
• A Certificate of Analysis for every batch.

Not sure a supplier is genuine? Read how to verify a pharmaceutical supplier. For the neighbouring markets, see our Japan, South Korea, Australia and New Zealand import guide.

Frequently asked questions