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

 

Inside this issue

     

Editorial

Dear readers,

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’’.

Prior to ExcipientFest Asia, there was an IPEC Federation meeting of representatives to discuss progress on the 2018+ Strategic Plan. This will be reported in the September edition and I also wanted to mention a workshop held after Federation discussions which was attended by key stakeholders from the China Pharmacopoeia Commission, EDQM, USP and WHO. Each group presented their perspectives on pharmacopoeial harmonisation and feedback from Frank Milek indicates that the regulators’ approach to this perennial subject will allow some radical rethinking of our approach within IPEC and what we can do to influence progress in a different way. When the IPEC Europe Board meets in September, this will be high on the agenda and after that we’ll be sharing with you how the debates in China will drive our next steps. So anyone with an interest in this area, be ready to get engaged! Our surveys always tell us this is an important topic so with some new direction, it will hopefully motivate many to help us revitalise harmonisation!

I look forward to talking with you again next month but meanwhile, enjoy what remains of this outstanding summer.

 

Frithjof Holtz

IPEC Europe chair

 

 

 

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