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 also the market seems ambitious with a focus on innovation and homegrown research and development. To enter the Chinese pharmaceutical market, one must navigate China's drug approval process, 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 China drug registration and approval process, from market strategy to dossier submissions and dossier compilation to the NMPA for the registration, to reduce the drug’s time to market.
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
The pathway for the medicines/drug registration in China depends upon the categorization of the drug product as per the China NMPA regulation. Understanding the Regulatory requirements for registration of drugs in China and the classification decides the Regulatory approval process in China, including for generic and new drug approvals.
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 (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, as part of the China drug approval process, 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, QC test and audit results. Once the review is complete and concluded approvable, the NMPA shall authorize a Drug Approval License.
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.
China Drug Registration and Approval - 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/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.
- 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.