China Drug Product Registration

Accelerated Approvals for Drugs Registration

The regulation states that the NMPA started the new drug review procedure and separated the approval process into the four categories listed below:

• Breakthrough approval
• Priority review
• Conditional approval
• Special approval

The applicant needs to know for which category of drugs do these review processes apply at which stage of drug development may apply.

Imported Drug Registration Process in China

1. The applicant submits the import drug registration form, the clinical study report, and other necessary documents.
2. The CFDA/SFDA review team evaluates the information and notifies the applicant if any more information is needed;
3. The SFDA CDE examination process takes around 120 days, and it takes an additional 160 days if further documentation is needed;
4. The CDE reviews the medication and reports to the SFDA/CFDA in around 40–50 days;
5. The SFDA/CFDA clearance process takes about 20–30 days. Also, the manufacturer/importer or applicant receives the import registration certificate.

Application for Clinical Trial

1. Application for clinical trial is submitted.
2. Depending on the application, CDE carries out the test report and overall documentation review which takes about 40-60 days depending on the product.
3. The evaluation report is sent to the CFDA with a recommendation regarding whether the product should proceed with a bioequivalence study or a clinical trial.
4. If it opts for clinical study, it can be divided into 4 phases.
5. The applicant may select the clinical trial hospitals from the provided list if their application for a clinical trial or bioequivalence study is approved. All research must be conducted in accordance with GCP (Goods Clinical Practice).
6. Following the clinical research’s successful conclusion, the manufacturer or applicant receives the approval document, which, together with the consent form and study reports, constitutes the documentation needed to submit an application for drug registration.
7. The information will be assessed and reviewed by the SFDA Evaluation Center. If it passes, the file is sent for final clearance and a five-year pharmaceutical registration certificate is provided.

Fees

1. Drug Master File:

• Drug Manufactured in China: 25650 USD
• Drug manufactured outside China: 51354.42 USD

2. New Drug Application:
3. Clinical Trial

• Drug Manufactured in China: 26822.76 USD
• Drug manufactured outside China: 52527.91 USD

1. Marketing authorization:

• Drug Manufactured in China: 60351.22 USD
• Drug manufactured outside China: 82968.96 USD

3. Generic Drug Registration:

• Drug Manufactured in China: 44425.20 USD
• Drug manufactured outside China: 70130.35 USD

Post Market Surveillance

• A robust pharmacovigilance system has been put in place by the NMPA to gather, analyze, and evaluate data on adverse drug reactions. This approach makes it possible to identify any new drug-related dangers or possible safety alerts. A vital part of the pharmacovigilance system, the National Adverse Drug Reaction Monitoring Information Network is responsible for tracking and assessing the safety of pharmaceuticals sold in the Chinese market.
• Risk Assessment and Evaluation: The NMPA carries out risk assessments and evaluations by utilizing safety data and documented adverse medication responses. Making judgments about the safety profiles of medications and assessing the frequency and severity of adverse drug reactions are aided by this method.