China Drug Registration and DMFs for APIs, Excipients & Packaging Materials

The National Medical Products Administration (NMPA) under the Ministry of Health (MOH) is in charge of all new drug registration approvals.

All drugs outside China must be registered via the imported drug application. Foreign-made APIs, excipients, and packaging materials need to register as DMFs.

In China, drugs are classified as 3 types:

1. Chemical Drugs – 6 classes
2. Biological Drugs – 15 classes
3. Traditional Chinese Medicine/Natural Drugs – 15 classes

The different types of drug applications in China are:

1. New drug application
2. Generic drug application
3. Imported drug application (includes foreign new drugs)
4. Supplemental application
5. License renewal

Application and Approval Procedures and Timeline for Imported Drugs

1. Submit application
2. Dossier content and format checking/notification of quality testing and specifications verification by the NMPA (35 days)
   • If needed, proceed with samples testing and standards verification by the NICPBP (65 days / 95 days for special drugs and vaccine products)
3. Technical evaluation for clinical trials by the CDE (90 days regular/80 days fast track review)
   • If needed, submit complementary data (4 months)
   • If needed, submit supplementary data for CDE evaluation (40 days)
4. Administrative approval by the NMPA (30-40 days)
   • If the NMPA does not approve, must begin the application process again
5. Approval for Clinical Trials
6. Notification of clinical trial protocol and list of investigators to the NMPA
7. Commencement of Clinical Trials
8. Submission of clinical trial results and other amended or supplementary data
9. Acceptance by the NMPA
10. Technical evaluation by the CDE (150 days regular/120 days fast-track review)
    • If needed, then submit complementary data (4 months)
    • If needed then submit supplementary data for CDE evaluation (40 days)
11. Administrative approval by the NMPA (30-40 days)
    • If the NMPA does not approve, must begin the application process again
12. Approval of imported drug application

Even if a product is approved elsewhere, the NMPA will most likely still require the foreign manufacturer to conduct at least some clinical testing in China before the drug is approved in China.

After a pharmaceutical product has received registration approval, it typically takes a further 18 months to obtain market access. This consists of three main steps: drug price approval, provincial bidding, hospital listing.

The first step towards market access is drug price approval. The retail price of a drug must be officially approved before the drug can be offered in any tendering or bidding process. This needs to be carried out in each province individually, and generally takes four to five months.

The second step is provincial bidding, where each province calls for drug manufacturers to participate in the bidding process drug tenders. A tendering committee will choose among the bids and determine which drug companies can distribute their products in that province. Usually, two to five suppliers of each drug are selected. This usually takes three to five months.

The last step is hospital listing. After a pharmaceutical product has won a provincial bidding process, it must be listed by each individual hospital. Once or twice a year, every large hospital creates a committee to approve new drugs to be included in the hospital’s formulary. Only pharmaceuticals listed on the formulary can be purchased by the hospital and prescribed to patients by physicians.

How a pharmaceutical company approaches the pricing, bidding, and listing process is key to successfully obtaining market access in China.