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Chinese Pharmacopoeia illustrates new framework for excipients

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European Pharmacopoeia
General
News
18 September 2018
Strasbourg, France

The EDQM has provided a platform for European and international medicine manufacturers to discuss new regulatory approaches in China on pharmaceutical excipients selection and quality control. During a workshop on 18 September in Strasbourg, the Chinese Pharmacopoeia (ChP) delivered the most complete picture of their roadmap on the quality of excipients in China.

The ChP illustrated the application of the new regulatory framework for pharmaceutical excipients. Under the new system, both excipients and pharmaceutical packaging materials play an increasingly prominent role in the manufacture of preparations and finished products. During the welcome speech, Susanne Keitel, Director of the EDQM, reminded how “the quality of medicines depends not only on the API, but also the performance of the excipients” and explained that the initiative was part of “the EDQM’s commitment to facilitate exchanges on regulatory aspects among medicine producers and authorities, a key aspect for ensuring quality of medicines from a global perspective”.

The event was attended by more than 60 participants, while another 181 participants joined the video broadcast of the event from remote in more than 30 different countries.  Other covered topics included updates on current priorities of the ChP e.g. chemicals and traditional Chinese Medicines, the participation of China in international initiatives such as ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and how the ChP is going to implement ICH guidelines in the future, as well as the latest developments in the cooperation between the ChP and the European Pharmacopeia (Ph. Eur.).

Pharmaceutical excipients are important components of medicines, which can directly affect the quality and safety of the final product. In order to strengthen further the quality and the safety of final products, the 2020 edition of the ChP will introduce a risk management system for excipients covering the whole process from raw materials and APIs to final products, as well as general technical requirements, packaging and storage. With the new regulatory framework the ChP has sought to put great importance to excipients and their review and approval management in order to guarantee the overall quality of excipients.

The initiative is part of the EDQM’s commitment to bring together all stakeholders involved in the pharmaceutical sector and promote dialogue and information exchanges at global level. It follows on from the Memoranda of Understanding signed last year between the EDQM and the Chinese Pharmacopoeia to promote cooperation on the safety and quality of medicines in China and Europe.

The presentations and the broadcast of the event are now available on-line on the EDQM website.

More information on the Ph. Eur. work programme.

More information on the Ph. Eur. 9th edition.

More information on the Memorandum of Understanding (MOU) between the EDQM and the Chinese Pharmacopoeia Commission.

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