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What is CDE?
China is the most populated country in the world and a lucrative market for pharmaceutical companies. With multiple aids from the Chinese government and public insurance, this pharmaceutical industry is growing massively.
Drug registration in China involves approval from the National Medical Products Administration (NMPA). The NMPA is the Regulatory authority in China that is responsible for drug registration. The NMPA works closely with the National Institute for Food and Drug Control (NIFDC) and the Centre for Drug Evaluation (CDE).
The CDE is majorly involved in evaluating drug clinical trial applications, drug marketing authorization applications, supplementary applications, and overseas drug production registration applications.
Prime Responsibilities of the CDE are as follows:
- Technical review of:
- Applications for drug clinical trials and drug marketing authorization
- Consistency evaluation of the quality and efficacy of generic drugs
- Drugs involved in emerging medical products such as regenerative medicine and tissue engineering
- Legislation: Participate in the drafting of laws, regulations, and normative documents related to the registration administration of drugs; organize the formulation and implementation of drug review norms and technical guidelines
- Research: On the theories, technologies, development trends, and legal issues related to drug review
- Drug review: Includes inspection and testing. Along with this, the CDE organizes consulting services & academic exchange and carries out international (regional) exchange and cooperation related to drug review
- Tasks assigned by the NMPA: Generally, tasks related to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are assigned by the NMPA
The CDE is involved in the review of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and drug re-registration applications also.
China’s pharmaceutical market is highly regulated and is controlled by complex regulations and IP laws. With a team of highly qualified professionals, Freyr can help you for quick, effective, and smooth drug registration procedure in China.