In response to the ardent demand of enterprises for pharmaceutical political interpretation, the annual CPhI International Pharmaceutical Political Q&A was successfully held in the form of online conference on December 15-17. More than 3000 people attended the meeting online, which was synchronized by Zoom and live broadcast.

This session of the International Pharmaceutical Policy Question and Answer Session is divided into regulation update topic, original and auxiliary package topic and biological drugs topic. The meeting invited institutional experts from WHO, Europe, the United States, the African Union and the Philippines to interpret relevant regulatory policies and updates of drug standards, as well as analysis of future trends.

Special topics on raw materials, auxiliary materials and packaging

In the topic of raw materials, auxiliary materials and Packaging materials of CPhI International Pharmaceutical Policy Question and Answer Meeting held on the afternoon of December 16th, The chamber invited five experts, Dr. Ulrich Rose from The European Medicines Quality Agency, Dr. Ling Xiao from the United States Pharmacopoeia Commission (USP), Dr. Wang Suming, chairman of IPEC International Excipient Association (China), Dr. Song Yu, expert of regulation group of Merck Chemical Technology (Shanghai) Co., LTD., and Gao Shan, chairman of IPEC China Quality Committee.

The United States

1. In its five-year plan for 2020-2025, the United States Pharmacopoeia made 15 new resolutions, including improving the efficiency of standard formulation and revision, developing high-quality public standards, developing biomedical standards, focusing on emerging areas such as continuous manufacturing, and providing comprehensive training, etc.

2. The United States Pharmacopoeia has established an expert panel on impurities in Pharmaceutical products that will revise the overall impurity control requirements of the United States Pharmacopoeia based on ICH Q3C and Q3D and based on extensive consultation with industry;

3. As for the control strategy of impurities, nitrosamine impurities in organic impurities and elemental impurities in inorganic impurities are more concerned by the United States Pharmacopoeia. General rules 232 and 233 are revised for elemental impurities. Nitrosamine impurities in addition to the release of 1469 important general principles, also issued six impurities standard substances;

4. Impurity testing methods are an important part of pharmacopoeia standards, and the universality, specificity and efficiency of testing are very important considerations for new and updated methods;

5. The United States Pharmacopoeia revised general Rules 87, 88 and 1031 in terms of package materials, mainly to reduce redundant tests, improve test types and keep the potential risks consistent, and replace in vivo tests with in vitro tests.


1. In recent years, through the adjustment of a series of regulatory documents, including the newly revised Drug Administration Law and Drug Registration Management Measures, the upper law of pharmaceutical excipients in China has been gradually improved, and the definition and management of excipients have been gradually clarified;

2. When carrying out research on technical changes of pharmaceutical excipients, the contents and reasons of the changes, the possible impact on drug quality, and the expected changes in the performance and function of pharmaceutical excipients should be considered;

3. The change of registration and filing of pharmaceutical auxiliary materials will trigger the change of pharmaceutical preparations, which can be divided into minor change, medium change and major change, etc. Relevant prescription study, sample test, quality comparison study and stability study should be carried out for pharmaceutical preparations.

4. The coping strategies for pharmaceutical excipients change should pay attention to high-risk strategies, differences in data requirements, maximum historical usage, classification of "other" data, etc. Once an auxiliary material is changed, the supplier of the auxiliary material should inform the holder of the preparation as soon as possible and update the information on the registration platform. The holder of the preparation should evaluate or study the impact of the change in time and submit supplementary application, record or report to the regulatory authority.

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