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Just now, the National Pharmacopoeia Commission officially released the outline
of the preparation of the Chinese Pharmacopoeia (2025 edition).
The outline proposes 6 main tasks:
The outline proposes 6 main tasks:(i)
Appropriately increase the scope of pharmacopoeia varieties, adhere to the principles of common clinical use, precise efficacy, safe use, mature technology and controllable quality, and continue to expand the coverage of catalogue varieties in combination with the adjustment of the national basic drug list and the national basic medical insurance drug list, and promptly include innovative drugs
.
(ii)
Improve the overall level of drug standards, further improve the safety and effectiveness of drugs, strengthen the formulation of highly exclusive detection methods and standard limits, and strengthen the safety control indicators
of high-risk varieties.
(3) Improve the drug standard system, strengthen drug research and development, production,
Quality control
of the whole process of circulation, use, supervision and other links.
It provides technical support
for encouraging the review of innovative drugs, the consistency evaluation of the quality and efficacy of generic drugs, and the reform of the related review and approval system.
(iv)
Improve mechanisms for forming drug standards, further implement the main responsibility of enterprises, support and encourage marketing authorization holders, scientific research institutes, social organizations and other social forces to participate in standards work, and clarify work procedures and technical requirements
.
(5) Strengthen international exchanges and cooperation, carry out research on the comparison of domestic and foreign drug standards, actively participate in the formulation of international standards, and actively participate in the coordination and mutual recognition
of international standards.
(6) Accelerate the construction of drug standard informatization, promote the digitization and networking of the Chinese Pharmacopoeia, improve the service level of drug standards, and accelerate the construction of
drug standard information platform.
