IPEC e-newsletter - Excipients Insight July/August 2018 - 31-08-18


Inside this issue


What's new in the field of excipients in China? An EDQM workshop has the answers.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is organising a workshop on 18 September – entitled What’s new in the field of excipients in China? – in collaboration with the Pharmacopoeia of the People’s Republic of China (ChP).

“The quality of pharmaceutical excipients is a hot topic for regulators worldwide,” EDQM director Dr Susanne Keitel told Excipients Insight. “There have been a number of significant and fundamental changes to the way excipients are regulated in China, and the purpose of this joint workshop is to provide some insights into [these] evolving regulatory requirements.”

The ChP has significantly increased the number of monographs covering excipients and it is important for stakeholders intending to do business in China to understand how these monographs are elaborated and what the future plans of the ChP are in this field, she continued.

This workshop will provide users and representatives from the industry with a unique opportunity to interact with key, high-ranking ChP officials, including Wei Zhang, Secretary General, of the ChP Commission, and to learn more from these leading experts on the technical and regulatory requirements applicable in China. The workshop programme also allows plenty of opportunities for discussions, questions and networking.

The event will cover topics such as:

  • The implementation of various examination and approval systems;
  • How standards for pharmaceutical excipients in the ChP are established;
  • Risk management, technical requirements and the applicability of excipients;
  • The requirements to be met for the declaration of technical materials; and
  • The quality control of excipients produced by different sources such as animals and plants.

“Harmonisation of pharmacopoeial monographs as such is of great importance for the globally acting industry,” said Keitel. “This is why we are particularly happy to collaborate with the ChP, for example in organising such workshops or collaborating with them at the level of the International Meetings of World Pharmacopoeias.”

“Providing safe, effective and good quality medicines and active pharmaceutical ingredients is a major concern all over the world. Hence, collaboration across international borders has become even more essential if we are to keep abreast of advances in science and share expertise and resources.“

The workshop is aimed at national regulatory bodies and professionals working in pharmaceutical companies in quality control, development, manufacturing, and regulatory affairs in the field of pharmaceutical excipients. It is also expected to attract many Chinese and international excipient and finished-drug manufacturers.

This is not the first time that the EDQM has organised events to facilitate exchanges of information with stakeholders and to promote co-operation with authorities worldwide. For example, it co-organised a workshop with the Indian Pharmacopoeia Commission (IPC) in Mumbai earlier this year which provided the opportunity to have an open exchange with Indian stakeholders.

“We have agreed with the IPC to hold a similar workshop in Europe to provide European stakeholders with a platform to interact directly with them,” said Keitel.

If you cannot make it to Strasbourg, you can register for the live broadcast to view this workshop remotely.  In addition, you will be able to submit your questions online throughout the day.




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