Mission & Organisation

Mission

The procedure for Certification of suitability, which is referred to in EU legislation, is a complement and a bridge between European Pharmacopoeia monographs and the need to prepare a file for licensing, and therefore is also a bridge between industries and health authorities. The role of the procedure is to assess and to conclude suitability of monographs to control chemical purity, microbiological quality and TSE risk (if relevant) for any substances, covered by a European Pharmacopoeia monograph and to be used in medicinal products.
The advantages of the procedure are full confidentiality of the submitted data, a centralised evaluation at EDQM that is then recognised by all Member States of the European Pharmacopoeia convention (36 countries) as well as by other countries, and the easing of the management of applications for Marketing Authorisation for medicinal products in these countries.
To complete this quality evaluation, EDQM has initiated in 1999 an inspection programme for manufacturing sites covered by a certificate (CEP), which is now running according to the EU Commission mandate given to EDQM for application of Directive 2001/83/EC and 2001/82/EC, as amended.
This programme optimises the available inspection resources through close collaboration with European authorities, as well as non-European inspection authorities.

The Organisation

The Steering Committee

The 3Cs (consultation, co-ordination, co-operation) that characterise the Certification procedure are implemented by the Steering Committee consisting of representatives of authorities. The Steering Committee takes decisions on general policy, reviews and comments on issues raised by Technical Advisory Boards, adopts guidelines and the inspections programme, and co-ordinates issues between the parties represented.  It is also responsible for the appointment of the assessors and the Technical Advisory Boards (TABs) and their Chairmen.
It meets twice a year, thus ensuring that decisions involving licensing, the European Pharmacopoeia and certification are taken in a coherent manner. For more information, see the Terms of Reference.

The Technical Advisory Boards (TABs)

Technical Advisory Boards have been set up for each field of the procedure (chemical substances, TSE risks substances and herbals). They consist of assessors involved in the procedure.
These Boards deal with any technical or scientific questions raised by the assessors, discuss technical guidance documents, submit scientific or technical issues to the Steering Committee and seek their advice whenever necessary. It meets one to three times a year or upon convocation when necessary. For more information see the Terms of Reference.

The Assessors

They are independent assessors belonging to or advising the authorities or administrations responsible for the evaluation of medicines, or belonging to the Official Medicines Control Laboratories (OMCLs), or scientific administrators belonging to the Certification Secretariat. They have appropriate competences for the evaluation of dossiers in one of the field covered by the certification procedure. Their role is to assess CEP applications and to draft up an assessment report.  All assessments take place on the EDQM's premises.

The Technical Secretariat

The Certification Division is a team of scientific administrators, secretaries and technicians responsible of the management of the confidential dossiers.