In March 2025, the Chinese National Medical Products Administration (NMPA) published a draft of the "Addendum for Sterile Drugs". Similar to Annex 1, the new GMP guideline rules the manufacture, control and quality management of sterile drugs. The draft is currently in the consultation phase.
A first glance at the document shows that, as in many other areas, China closely follows the GMP requirements applicable in the European Community. For example, with regard to the implementation of a CCS Contamination Control Strategy. In some areas - such as the basic design of cleanrooms and protection concepts - the requirements in China even go beyond those in the West.
gempex's GMP experts have been active in China since 2005 and have closely followed the development of regulatory requirements there ever since. They know the details, especially regarding inspections by the Chinese authorities and their special focus. Over the years, gempex's Chinese colleagues have successfully prepared numerous well-known Western companies at inspections by the Chinese authorities, among other services.
gempex also supports investment projects in China planned by Western companies with competent consultancy and active local presence. This has enabled gempex China to open its third location. With offices in Guangzhou, Suzhou and now also in Chengdu, the most important industrial zones in the pharmaceutical, chemical and biotechnology industries are covered by gempexChina with local know-how and comprehensive expertise in GMP, GDP and communication with authorities.
If you have any questions about the new regulatory requirements in China or the special features of Chinese GMP inspections, please contact gempex via contact@gempex.com.
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gempex China - Compliant, Efficient and Executable GMP Solutions for Global Life Science Companies
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