Excipients Inside June 2018 – IPEC Europe

Dear readers,

It’s hard to believe that we’re issuing our June publication already and we find ourselves heading for the summer break. And of course, we’re now preparing for those mid-year reviews to measure progress to ensure we can meet our goals by the end of the year. Not only that but September is not far away when the Board will convene with an eye to 2019. We’ll be revisiting our Agenda 2020 to confirm our strategic direction and that we’re working on the right things to get there. More on this in future issues.

 

Meanwhile, our committees are getting on with things including the IPEC Europe Pharmacopoeial Review & Harmonisation Committee (PR & HC). This group has met twice this year and is developing a structure which will enable us to provide a better forum for important pharmacopoeial issues. We now have a core team in place but we would still like more volunteers who can actively participate in executing its objectives, not least in designing a new approach to excipient harmonisation, more of which later. So once again, let me make a call for any volunteers from our members to get in touch with the secretariat. Thank you for listening!

 

On the subject of harmonisation, in July, the IPEC Federation will convene for a face-to-face meeting in Beijing, around the ExcipientFest Asia programme of events. An important part of that will be a discussion on how the IPEC Federation intends to move forward its harmonisation agenda which in turn will help to direct IPEC Europe’s position. We’re also hoping that at the same time, we can have discussions with some key stakeholders on international developments within PDG and other pharmacopoeias, where global harmonisation appears to have faltered. We see more and more collaborations between pharmacopoeias bilaterally, note the recent intentions to cooperate between EDQM and India and China Pharmacopoeias. We, as part of the IPEC Federation, need to understand how we can dovetail into those efforts as industry collaboration is pivotal to making a success of harmonisation efforts. For sure in our July/August issue we’ll be reporting back on how these meetings went. And on the horizon there are meeting tentatively planned with PDG and EDQM so we need to get our thoughts together before then.

 

The summer months are often referred to as the ‘crazy season’ when little seems to get done but there are still some burning issues out there which we need to follow. As members will know, the discussion in France related to the use of Titanium Dioxide in food continues. And of course, China has published its requirements for Registration Documentation for Pharmaceutical Excipients and Excipient Nomenclature. While IPEC Europe’s QRAC and PR&HC teams will be working diligently through these requirements, despite the temptations of sun and sand, of course, any member is welcome to submit its comments to the Secretariat for compositing with other remarks and those of other PECs.

 

As news items are often in short supply in July and August, we’ll be distributing a combined issue for those months but for any items of major significance, we will issue an alert to our members.

 

So for now, bonnes vacances to you all!

Frithjof Holtz

IPEC Europe chair

 

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• PIC/s formally adopts EC’s excipient GMP risk-assessment guidelines
• PDG holds first videoconference meeting
• EMA starts new consultation on ICH Q3D
• New EDQM guideline “How to read a CEP”
• Download IPEC guides
• Recommended reading
• Events calendar