Webinar - European Regulatory Framework

An IPEC Europe webinar

European Regulatory Framework


20 September 2022 - 15:30-16:15 CEST

This webinar aims to provide a short introduction into the regulatory requirements of excipients in Marketing Authorization Applications in Europe. References to excipients in the guidelines for the dossier for application for marketing authorization of a medicinal product and examples are discussed. A further attention is turned on the supplier approval process to fulfill the requirements according to a formalized risk assessment for ascertaining the appropriate GMP practice for excipients.

IPEC Europe develops and publishes guidelines to promote the best use of excipients in medicines as a means of improving patient safety.


Since 1992, IPEC Europe brings together producers, distributors and users of pharmaceutical excipients to exchange good practices and develop harmonised standards.


Member of EXCiPACT

EXCiPACT is a non-profit organisation that owns and manages oversight of the independent, high quality, third-party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

IPEC Federation

Member of IPEC Federation

Together with its sister associations (Americas, Japan, China, India), IPEC Europe is a member of IPEC Federation, who promotes quality in pharmaceutical excipients worldwide.