How are Chinese standards for pharmaceutical excipients harmonized with ICH Q3C?

On August 1, 2022, in order to cooperate with the related review of pharmaceutical excipients and preparations, and to strengthen the coordination between the "Chinese Pharmacopoeia" and the relevant guiding principles of ICH, the official website of the State Pharmacopoeia released "About soliciting the "Chinese Pharmacopoeia" pharmaceutical excipient standards and ICH Q3C "Letter of Coordinating Opinions on the Plan", the deadline for the publicity period is September 25, 2022, and a single stone caused a thousand wav.

Implementation of the ICH Q3C Guidelines in China

(1) 2017 is called the first year of ICH in Chi.

(2) The National Medical Products Administration (NMPA) of China was elected as a member of the ICH Management Committee at the 2018 First General Meeting of ICH held in Kobe, Japan on June 7, 201

(3) The State Food and Drug Administration issued an announcement (.

(4) On December 21, 2021, in order to promote the technical standards of drug registration to be in line with international standards, after research, the State Drug Administration decided to apply the "Q3C (R8): Impurities: Residual Solvents" International Conference on Harmonization of Human Drug Registration Technology ( ICH) guidelin.

Why did the Chinese Pharmacopoeia introduce ICH Q3C?

Pharmaceutical excipients refer to the excipients and additives used in the production of drugs and the formulation of prescriptions, which have been reasonably evaluated in terms of safety, and the substances contained in pharmaceutical preparations, and the quality of pharmaceutical excipients has an impact on the safety of dru.

Three, "Chinese Pharmacopoeia" pharmaceutical excipient standards and ICH Q3C coordination four parts

China began to pay attention to the control requirements of residual solvents in dru.

(1) The draft of the Chinese Pharmacopoeia standard for pharmaceutical excipients and the ICH Q3C coordination plan was publicly solicited for commen.

(2) According to the feedback, form the revised draft of the four general rules and general rule 0251 of the Chinese Pharmacopoeia based on the coordination of ICH Q3C, and form the coordination plan of the text of the Chinese Pharmacopoeia for medicinal excipient varieties and ICH Q3C, and make it publ.

(3) After the relevant work procedures for the formulation and revision of the Pharmacopoeia standards, the revised contents of the four general regulations and general chapter 0251 of the Chinese Pharmacopoeia based on the coordination of ICH Q3C are included in the Chinese Pharmacopoe.

(4) Determine the coordination plan between the text of the Chinese Pharmacopoeia of pharmaceutical excipients and ICH Q3C, and determine how the Chinese Pharmacopoeia contains the residual solvent inspection items according to the principles in the plan when adding or revising the text of the variety; 》For the residual solvent inspection items that have been included in the text of the medicinal excipient varieties, according to the feedback, timely organize and carry out research:

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       About the author: Di Shui Sinan, male, senior biomedical engineer, based on the quality management of the biomedical industry, focusing on the biomedical indust.