Medicinal Products Regulatory Support in China

Overview

National Medical Products Administration (NMPA) (formerly known as China Food and Drug Administration [CFDA]), is the main Regulatory authority responsible for pharmaceutical product registration in China. The Center for Drug Evaluation (CDE) of NMPA is responsible for evaluating drug clinical trial applications, drug marketing authorization applications, supplementary applications, and registration renewal applications of drugs manufactured overseas.

Medicinal Product Classification

The NMPA regulations classify drugs into the following categories.

  • Chemical Drugs (small molecules)
    • Total nine (09) classes
    • Two (02) classes related to the NCE (marketed outside China, not marketed globally)
  • Biological Products (Thirteen (13) classes)
  • Traditional Chinese Medicine (Ten (10) classes)

Medicinal Product Registration

The pathway for the registration of medicines in China depends upon the categorization of the drug product as per the NMPA regulation. The classification decides the Regulatory approval process in China.

A foreign manufacturer/applicant must have a legally appointed local agent responsible for the pharmaceutical Regulatory affairs in China to carry out the registration process with the National Medical Products Administration. The applicant must submit the Marketing Authorization Holding (MAH) application to the NMPA.

For imported drugs, the marketing approval includes the drug approval license. The applicant needs to submit the M1 administrative documents, drug Information, and the M2-5 CTD dossier. The M1 should include the cover letter, application form, labeling, clinical trial information (if needed), specification, production-process information, and approval-supporting documents (if needed), such as the DMF certification, GMP certification, COPP, LOA/POA, etc.

The CDE carries out a technical evaluation of the dossier content after a comprehensive review of the application dossier, verification, and audit results. Once the review is complete and the NMPA has approved the product, the CDE authorizes a Drug Approval License.

Important Validities

The Drug Approval License is valid for five (05) years, and according to the NMPA regulations, the MAH must apply for the renewal certificate six (06) months prior to the expiry of the validity period.

Freyr Expertise

  • Pharmaceutical Regulatory Services & Consulting Solutions in China
  • End-to-end Regulatory Support for the Medicinal Product Registration in China till Approval from NMPA
  • Local Representative support and Pharmaceutical Regulatory Affairs in China
  • Support with Pre-application Meeting with NMPA/Liaison with HA until Approval
  • Business Strategy and Regulatory Market Consultation
  • Registration Category, Application Type, and Classification
  • eCTD Publishing and Submissions
  • Support for Translation Services
  • Regulatory Intelligence
  • Medicinal Products Clinical Trial – Regulatory Support in China
  • Post Market Approval Services-Periodic Safety Reports, Benefit-Risk Reports (PBRERs, PSURs)
  • Regulatory Software Solutions

Location

No.99-OL-10-202105025, West section,
Hupan Road, Xinglong Street,
Tianfu New District, China (Sichuan)
Pilot Free Trade Zone, China

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