The National Medical Products Administration (NMPA) and the National Health Commission have announced the release of the first supplement to the Pharmacopoeia of the People’s Republic of China (2020 Edition), which will come into effect on March 12, 2024. This update marks a significant expansion and refinement of the country’s pharmaceutical standards and regulations.
New Drug Varieties and Revisions
The supplement introduces a total of 47 new drug varieties to the Pharmacopoeia. These are distributed across different sections: 8 in the first part, 28 in the second part, and 11 in the fourth part. This addition will enhance the range of pharmaceutical options available and strengthen the quality control measures for these new entries.
Updates to Biological Products and General Principles
The third part of the supplement revises the General Principles of Biological Products and the General Introduction to Biological Products. Updates include quality control of raw materials and excipients used in the production of biological products, as well as management and quality control of bacterial and viral strains used in the production and testing of these products. The General Introduction to Recombinant DNA Protein Products for Human Use has also been updated.
New Guidelines and Testing Methods
Both the third and fourth parts of the supplement have added new general principles and guiding principles. These include in vitro pyrogen testing using the reporter gene method, guidelines for impurity control technology in human vaccines, and guidelines for bioassay based on genetically modified cell lines. These additions will provide clearer directives for the development and testing of biological products, ensuring safety and efficacy.
Revisions to Existing Varieties
In addition to the new additions, the supplement has also revised some varieties that were previously listed in the pharmacopoeia. These revisions aim to align with the latest scientific advancements and improve the overall standardization of pharmaceutical products in China.
Conclusion
The release of the first supplement to the 2020 Edition of the Pharmacopoeia of the People’s Republic of China reflects the country’s commitment to advancing pharmaceutical standards and ensuring the safety and efficacy of drugs available to its population. With the addition of new drug varieties and the revision of existing ones, China continues to modernize its approach to pharmaceutical regulation.-Fineline Info & Tech
