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China Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

MoH: Chinese Ministry of Health

MoH Website: http://en.nhc.gov.cn/

Regulatory Agency: National Medical Product Administration

Regulatory Agency Website: http://english.nmpa.gov.cn/

License Validity: 5 Years  

Renewal of License: 6 Months before expiration.

Local Authorised Representative: Yes

Timeline for Approval: 1-2 years

Drug Classification:

Chemical medicine

  • Innovative drugs
  • Improved new drugs
  • Generics

Biological products

  • biological products
  • Improved new biological products
  • Marketed biological products (including biosimilars)

Traditional Chinese medicine.

Overview

  • The National Medical Products Administration (NMPA) is the Chinese governmental agency is responsible for regulating the development, production, and sale of pharmaceuticals, medical devices, and cosmetics.
  • The main regulatory agency managing drug registrations, creating specifications for drug registrations, and setting up the processes for evaluation and approval of drug registrations is the National Medical Products Administration (NMPA).
  • Applications for drug clinical trials, drug marketing permission, supplemental applications, and drug re-registration for medications made abroad must be reviewed by the NMPA’s Drug Evaluation Center (CDE).
  • There are two registrations pathways for foreign manufacturers:
  1. Improved new/Innovative drug
  2. Imported drugs
  • There are two clinical strategies:
  1. Parallel development
  2. Sequential development
  • All the foreign drug that is intended for use outside of China must register as a DMF via the Imported Drug Application.
  • For New drug applications (NDA) NMPA has initiated 4 programs for accelerating the review and approval of drug which includes-
  1. Conditional approval (CA)
  2. Breakthrough therapy designation (BTD)
  3. Priority review (PR)
  4. Special approval (SA)
  • The NMPA and its partner organizations offer communication, technical assistance, resource allocation, and a reduction in the applicant’s review time if the NDA falls into any of these categories.
  • Importers or foreign manufacturers without legal representation must apply through agent services for the registration of generic products. Once the application has been filed with the CFDA, CDE reviews the product.
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Documents Required for drug registration in China

  1. The dossier shall be directory as per the “Provisions of Drug registration” for application items.
  2. Document with the information: Name of application item or drug/product, item number, applicant name, address and contact number.
  3. Import License (Import drug registration application form)
  4. Approval Certificate
  5. Import quota certificate (wherever applicable)
  6. Inspection or Clinical testing certificate (where applicable)]
  7. Quality and safety license

Review process for drug marketing authorization

  1. Submission of drug marketing authorization application by Applicant.
  2. Drug registration inspection. (acceptance will be given if they meet the requirements)
  3. Comprehensive review of accepted drug marketing authorization applications by Drug Evaluation Center (CDE), pharmacy, medical, and other technical personnel.
  4. After completion of the comprehensive examination, a drug registration certificate is issued. The application is denied if the thorough evaluation is not accepted at the end.

Drug approval process in China

  1. submission of a New Drug Application (NDA) to the NMPA by applicant.
  2. The NMPA reviews the NDA, following which it conducts an on-site inspection of the applicant’s manufacturing facilities.
  3. The NMPA may also request additional clinical data or other relevant information from the applicant.
  4. If the NMPA is satisfied with the NDA, it will approve the drug for sale in China.

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
  1. New Drug Application:
  2. 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
  1. 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.