IPEC e-newsletter - Excipients Insight April/May 2018 - 15-05-18


Inside this issue



Welcome, readers to our spring edition!

Reflecting on what has happened during the past two months, again I am drawn to the subject of regulations, and not just those that impact directly or indirectly on pharmaceutical excipients. Surprisingly, I’m talking about those areas where we wish there might be some regulatory processes in place to better protect the intellectual property of particularly, novel excipients. Through our Quality & Regulatory Affairs Committee (QRAC), IPEC Europe is again looking at whether the time is right to encourage setting up a European master file system for excipients. This edition reports on the groundwork that a task force is doing to evaluate if the political environment has changed, whether legislation of this type could encourage greater use of novel excipients and - in turn - drive the introduction of innovative products in Europe for the benefit of patients. Regulations can be good news and we look forward to reporting of our progress on this initiative. As ever, your thoughts and comments on how we approach this would be welcomed by the task team.

Continuing on this theme, the highlights of the first Board meeting of 2018 touch upon the need for us to strengthen our ‘radar’ to ensure we capture all new and revised guidance touching excipients. Our members will be aware that recent developments on Titanium Dioxide E171 by the food safety agency EFSA could have major consequences for drug products too, similar to the situation we reported for Iron Oxide E172 in September 2017. While I don’t want to go into the details of those issues here, I want to highlight the growing need that we don’t only need to monitor regulations related to the healthcare sector but also related fields such as foods, chemicals and cosmetics. We need to be vigilant so we, representing suppliers and users in excipient supply chain, can raise any issues with medicines legislators as early as possible.

And finally, I’d like to acknowledge contributors to the two successful events we’ve been involved with this month. Our webinar on stability testing for excipients was very well received and IPEC Europe had a big presence at the second Making Pharmaceuticals venture in 2018 at Coventry in the UK, hosting part of the speaker programme and through our exhibition stand. Reaching out to the wider world via virtual and tradition media, helps to share our vision for excipients and what we do. So, Christian Becker, Liz Meehan, Iain Moore and Tanja Natterer, thank you so much for your involvement and representing IPEC Europe so well.

Until the next time, enjoy this edition.

Frithjof Holtz

IPEC Europe chair




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