Le Conseil International des Excipients Pharmaceutiques - Europe
Budget
€10 — €0
EP Access
0
accredited persons
Staff
1
0.25 FTE
EU Grants
None
Mission & Goals
1. To be the primary voice of European producers, suppliers and users of pharmaceutical excipients. 2. To develop, implement and promote voluntary, harmonised guidance for the pharmaceutical industry which is designed to ensure that excipients used in finished drug products meet the appropriate standards for quality, safety and functionality. 3. To assist, educate, and cooperate with other industry organizations and scientific bodies working to advance public health on matters relating to the manufacture, use and functionality of excipients. 4. To provide real-time information on excipient legislation via, for example, the IPEC Europe website (https://www.ipec-europe.org) and the newsletter ‘Excipients Insight’.
EU Legislative Interests
The Revision of the EU general pharmaceuticals legislation: https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en Directive 2011/62/EU of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products European Commission Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (OJ 2015/C 95/02)
Communication Activities
IPEC Federation Position Statement on EU Guidelines on Risk Assessment for Excipients https://www.ipec-europe.org/guidelines.html IPEC Europe Task Force acts to help industry meet EU risk assessment guidelines for excipients https://www.ipec-europe.org/guidelines.html
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
IPEC Europe is member of IPEC Federation (ipec.org) and of EXCiPACT (excipact.org)
Organisation Members
The complete list of IPEC Europe members can be found on the website: https://www.ipec-europe.org/our-members.html
Commissioner Meetings
No recorded meetings with EU commissioners.