Medicinal Products

End-to-end support from experienced Regulatory experts.

Medicinal Products Regulatory Support in China - Overview

As the world’s best pharmaceutical manufacturing powerhouse, China offers many business opportunities for pharma manufacturers. Not only have the Chinese pharmaceuticals seen a rise in FDA approvals for generic medication, but the market also seems ambitious, with a focus on innovation and homegrown research and development. To enter the Chinese pharmaceutical market, one must navigate the Drug Registration and Approval process in China, which includes obtaining approval from the National Medical Products Administration (NMPA). Understanding the Regulatory Requirements for Registration of Drugs in China is critical. With proven Regulatory affairs consulting, Freyr assists manufacturers in streamlining the Drug Registration in China process, from market strategy and Regulatory strategy for drug development in China, to dossier submissions and dossier compilation to the NMPA for registration, to reduce the drug’s time to market. Freyr also supports key requirements such as DMF submission of API, excipients, and packaging materials, ensuring complete and compliant documentation for review.

Medicinal Product Drug Classification in China

The NMPA regulations classify drugs into the following categories.

  • Chemical Drugs (small molecules).
    • Total nine (09) classes (including the sub-classes) .
    • Two (02) classes related to the NCE (marketed outside China, not marketed globally).
  • Biological Products for preventive purposes (Thirteen (13) classes including sub-classes); Therapeutic biological products (nine (09) classes including sub-classes); IVDs regulated by biological products (two (02) classes)
  • Traditional Chinese Medicine (Ten (10) classes).

Medicinal Product Drug Registration & Approval Process In China

The pathway for the medicines/drug registration in China depends on the categorization of the drug product as per the China NMPA regulation. Understanding the Regulatory requirements for registration of drugs in China and classification determines the Regulatory approval process, including both new drug and China generic drug approval process.

A foreign manufacturer/applicant must appoint a MAH & Legal Representative responsible for the pharmaceutical Regulatory affairs in China to carry out the registration process with the National Medical Products Administration (NMPA), ensuring adherence to China Pharmaceutical Regulations. The applicant must submit the Marketing Authorization Holder (MAH) application to the National Medical Products Administration (NMPA).

For imported drugs, the Drug Registration and Approval process in China 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 Center for Drug Evaluation (CDE) carries out a comprehensive review technical evaluation of the dossier content after a technical review of the application dossier, Drug name verification, Quality test for drug registration, NMPA on-site inspection to assess GMP compliance and manufacturing standards, and audit results. Once the review is complete and concluded approvable, the NMPA shall authorize a Drug Approval License.

For eligible products that meet urgent therapeutic needs, Freyr also supports submissions under priority demands of medicinal products of China market, and navigates pathways that enable accelerated review procedures to expedite approvals, post-approval compliance support, including pharmacovigilance requirements of medicinal products, safety reporting, and lifecycle maintenance to ensure continuous market compliance in China.

In addition, Freyr assists in evaluating the acceptability of overseas clinical data as part of the dossier strategy, ensuring alignment with NMPA expectations and minimizing delays.

Important Validities

The Drug Approval License is valid for five (05) years, and according to the NMPA regulations/China Pharmaceutical 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/China Drug Registration till Approval from the National Medical Products Administration (NMPA).
  • Local Representative Support and Pharmaceutical Regulatory Affairs in China.
  • Support with Pre-application Meetings with NMPA and Health authority consultation meetings / 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.
  • Guidance on RTQ (Response to HA queries) to ensure timely and compliant responses.
  • Application support for IND/CTA application, including preclinical and clinical documentation readiness.
  • Support for NDA/ANDA/BLA application, including formatting, submission, and agency interactions.
  • Comprehensive support for both the China Generic drug approval process and new drug approval process in China
  • Regulatory Intelligence Support.
  • Medicinal Products Clinical Trial - Regulatory Support in China.
  • Post Market Approval Services - Periodic Safety Reports, Benefit-Risk Reports (PBRERs, PSURs), post-approval change management, annual report submission etc.
  • Regulatory Software Solutions.