IPEC e-newsletter - Excipients Insight January 2010 - 28-01-10

 

Inside this issue

     

Word of the Chair

Firstly I'd like to wish all our members and partners a happy and prosperous New Year!  I am looking forward to meeting many of you at our seminar and AGM in Cannes later this month.

As I look ahead to 2010, it seems that the number one topic in the year ahead will be increased regulatory scrutiny of those who supply and use excipients, and this will be covered in depth in our seminar programme this year.

The headline news at the moment is the proposed EU Directive on falsified medicinal products which, as you can read in our lead article this month, has been extended in scope to include excipients in the rapporteur's proposed version. This is an important piece of legislation and necessary to protect Europe's citizens from unsafe medicines, and IPEC Europe welcomes it. However, we believe it is essential that these changes impacting excipients are covered by the Directive in an appropriate way, and IPEC Europe board has taken the challenge to strengthen its advocacy plan in 2010.

IPEC Europe has now drawn up a position paper that suggests some amendments to highlight the different requirements between excipients and active pharmaceutical ingredients in GMP and GDP, recognising that many excipients are used in a broad-range of non-pharma applications.

Our certification project, which calls for third-party audits of excipients, is a proactive solution proposed by the industry,  and may alleviate the increased burden of inspections that would follow if the proposals are implemented as they stand.

IPEC Europe is of the opinion that the absence of excipient drug master file (EMF) system for Europe is a key barrier for information sharing and innovation. The importance of an EMF system is discussed at length in a new approach paper developed by the Quality and Regulatory Affairs Committee.

Among the other key developments for IPEC Europe in 2010 will be a continuation of a drive to increase our focus on the science of excipients, something that is already underway in our Quality by Design (QbD) project.

Global harmonisation for guidelines and compendia remains a key objective  for IPEC Europe. The stage is now set for all the regional IPECs to speak with a single voice via the new IPEC Federation, which will hold its first General Assembly in Cannes, ahead of our seminar, to finalise and sign off the by-laws.

IPEC Europe has seen a phenomenal growth in membership in the last couple of years - in the region of 20% - and this has increased our resources and strength. We recognise that as the organisation grows, so do the requirements and expectations of those we represent. We need your continuous contribution to build a successful world for excipients.  Please don't hesitate to get involved in our committees and projects and bring your own expertise to the table.

As you can see this first edition of Excipients Insight for 2010 comes to you in a new HTML format designed to make our newsletter easier to navigate and read.  Many thanks to our secretariat and our Vice-Chair who devoted valuable time to redesign our website for efficiency. The Board and I hope you find the new format useful and welcome your feedback, comments and suggestions for improvement.

Finally, I would like to say a warm thank you to all company members that provide valuable time from their employees to contribute to the IPEC Europe mission.

On behalf of IPEC Europe board,


Patricia Rafidison


Chair to IPEC Europe

 

 

 

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