Pharmaceutical, API, and Excipients Product Registration in China

Pharmaceutical and API Product Registration in China

While there are many domestic Chinese pharmaceutical companies, foreign companies remain the dominant players in the Chinese drug market. Currently, the majority of domestic pharmaceutical companies in China are too small to compete with foreign companies. Therefore, almost all Chinese domestic pharmaceutical manufacturers are focused on producing generic drugs. Compared with foreign companies, local companies have made little investment in research and development.

Pacific Bridge Medical can help your medical company with all aspects of pharmaceutical, API, or excipients product registration. Our services include assisting with regulatory strategy, application submission, China local agent representation, clinical trials, GMP compliance, and more. We can obtain approval for any medical product your company needs to register in China.

Click on the questions below to find out more information on the provisions and guidelines that regulate drug development and approval in China.

Which regulatory bodies in the Chinese government are responsible for pharmaceutical, API, and excipients product registration in China?

The Chinese Food & Drug Administration (CFDA) under the Ministry of Health (MOH) is in charge of all new drug registration approvals.

Do pharmaceutical, API, and excipients products in China require registration?

All drugs, APIs, and excipients manufactured outside China must be registered via the imported drug application. Foreign-made APIs need to undergo a process similar to drug registration.

What are the different regulatory classifications for pharmaceuticals?

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

What does the registration pathway look like for pharmaceutical products?

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 CFDA (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 CFDA (30-40 days)
    • If the CFDA does not approve, must begin application process again
  5. Approval for Clinical Trials
  6. Notification of clinical trial protocol and list of investigators to the CFDA
  7. Commencement of Clinical Trials
  8. Submission of clinical trial results and other amended or supplementary data
  9. Acceptance by the CFDA
  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 CFDA (30-40 days)
    • If the CFDA does not approve, must begin application process again
  12. Approval of imported drug application

Are local clinical trials required for registration?

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

Contact us today for a free consultation with a China regulatory affairs specialist to discuss your specific needs.

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