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The State Food and Drug Administration (SFDA) is a Chinese drug Regulatory Authority established to restructure and replace the State Drug Administration (SDA). SFDA governs all the drug registrations and approvals. It has five units to coordinate all the activities. Every unit has a specific role in aiding the registration of drugs in China.

The five units are:

  • The National Institute for the Control of Pharmaceutical and Biological Products (NICPBP)
  • Centre for Drug Evaluation (CDE)
  • Certification Committee for Drugs (CCD)
  • Clinical Data Repository (CDR) and
  • Chinese Pharmacopoeia Commission (CPC)

The NICPBP mainly conducts sample examinations on drugs. It then verifies the drug product standards.

NICPBP is responsible for preparing and establishing Chinese national standards and is authoritative in conducting post-marketing quality surveillance of drugs. It also prepares, calibrates, preserves, and distributes physical standards in China.

NICPBP, along with the US Pharmacopeial Convention (USP) has signed a Memorandum of Understanding (MoU). This was done to improve the quality of medicines in China as well as in the countries that import the Chinese pharmaceutical drugs.

This type of collaboration among different bodies will give rise to a more regulated flow of drugs in the market and then to the consumer.  The collaboration majorly focuses on:

  • Collaborative testing of physical reference standards for drugs
  • Exchange of scientific staff and expertise
  • Development and validation of analytical procedures and technology
  • Collaboration on projects such as methods and techniques for detecting counterfeit and substandard drugs
  • Quality control of biotechnology products

NICPBP is just another body within the SFDA that helps to maintain stringent pharmaceutical regulations in China to serve quality medicines to everyone.

China’s pharmaceutical market is highly regulated and dynamic. It is controlled by different organizations within the SFDA. With a team of highly qualified professionals, Freyr can help you with end-to-end Regulatory services in China. Consult Freyr today!