IPEC e-newsletter - Excipients Insight October 2018 - 31-10-18


Inside this issue


Chinese Pharmacopoeia presents new framework for excipients

The Chinese Pharmacopoeia (ChP) gave a comprehensive rundown of its roadmap for ensuring the quality of excipients in China at a workshop hosted by the European Directorate for the Quality of Medicines (EDQM) last month.

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, Dr 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.).

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




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