This issue covers the following topics:
- Focus on co-processed excipients
- ADM joins IPEC Europe
- Last chance! 7th annual conference on pharmaceutical excipients
- IPEC Europe calendar
- What's new in the field of excipients in China? An EDQM workshop has the answers.
- EMA cuts operations as Brexit staff losses exceed expectations
- CMDh rules on hydroxyethyl starch solution safety
- EFSA says it does not need to reopen opinion on TiO2 safety
- Work starts on ICH Q13 Continuous Manufacturing
- EU, Japan expand MRA on inspections
- Recommended reading
- Download IPEC guides
- Events calendar
It is unusual to be writing an editorial in August itself which is, as for many of you, our ‘holiday’ period. So, always striving to do something different, publishing this week does allow me to stay that despite our assumption that little gets done in the summer months, in fact it seems quite the opposite, for 2018 at least. Admittedly, much of the activity stems from China, with two draft regulations on Nomenclature of Pharmaceutical Excipients and an Annex to Announcement 146 on Filings for Pharmaceutical Excipients out for consultation for which responses from industry and others are due imminently. These were sent out to our membership and while I know it’s not the best time of year to be reaching out for comments, ‘it is what it is’ and we must do our best! So thanks to those of you who were able to network these documents within your organisations so we can provide representative feedback to the China Pharmacopoeia Commission and the Center for Drug Evaluation.
And to mention China again, in July IPEC Europe attended the event organised by IPEC China, ExcipientFest Asia where our Vice Chair, Dr Frank Milek, ably presented on the topic of managing the many challenges of excipient supply chains. At the core of the key messages he delivered is how our GDP guide can help in surmounting barriers and its very rewarding to see one of IPEC’s work products, to which many of you contributed, get the attention of a broader audience. It is interesting to learn who attended this event. The regulations in China relating to excipients issued more recently explicitly spelled out that the drug manufacture is responsible for the quality of excipients among other things. No surprise then that this event attracted great interest from the domestic pharmaceutical industry, be they local or international companies. It served as a reminder to me of our unique mix of members and how important it is that we hear perspectives from each component so we can confidently claim we speak with that ‘’one voice’’.