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May 22, 2024
Approximately 5 minutes
China's National Medical Products Administration (NMPA): Regulatory Body and Recent Reforms
China's National Medical Products Administration (NMPA)
The National Medical Products Administration (NMPA) is the national regulatory body in China responsible for the oversight of drugs, cosmetics, and all medical devices, including In-Vitro Diagnostics (IVDs). Formerly known as the China Food and Drug Administration (CFDA), the organization was renamed in 2018. The NMPA is based in Beijing and is the key competent authority for issuing the mandatory Medical Device Registration Certificate (MDRC) for foreign products.
Strategic Goals and International Standing
The NMPA is actively working to establish itself as an internationally recognized regulatory body.
- International Alignment: The agency is continually updating its standards and regulations to align with global best practices and expectations.
- Reference Country Status: Currently, NMPA approval is generally not recognized by most countries as a Reference Country for expedited review pathways. However, this is expected to change as the NMPA's standards evolve, which would significantly benefit local Chinese manufacturers and early market entrants in Asia.
Significant Regulatory Reforms
In recent years, the NMPA has implemented several updates aimed at increasing efficiency and transparency in the registration process:
- Clinical Trial Clarity: Increased transparency regarding clinical requirements through the publication of Clinical Trial Exemption Lists and the provision of guidelines for Clinical Evaluation Reports (CERs).
- Classification Guidance: Providing more official feedback routes and classification guidance before manufacturers formally submit their applications.
- Process Improvements: Notable improvements in overall registration review times and the simplification of the process for transferring product licenses from one Legal Agent to another.
- Electronic Submissions: Implementation of the Electronic Regulated Product Submission (eRPS) system for new and renewal applications.
Regulatory Documentation
The NMPA regularly issues compulsory standards, draft guidance documents, and new regulations on its official website, which are essential reading for manufacturers seeking market access in China.
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