EMEA Transparency
This article was originally published in SRA
Executive Summary
Agency reveals names of working group members
Agency reveals names of working group members
The European Medicines Agency (EMEA) has for the first time published the names of those who sit on the working groups that report to its four scientific committees. It has also begun recruiting for the new post of senior medical director.
These moves are part of the EMEA's continuing drive to increase transparency. It has set up new web pages for each of its four scientific committees, the CHMP (human medicines), the CVMP (veterinary medicines), the COMP (orphan medicines) and the HMPC (herbal medicines)1.
All the names, profiles and declarations of interests of the members of the four committees have been published on the site for some time. Now the names of the members of all the working parties that report to each committee, as well as a description of what each group does and its work programme, are available via the new web pages. Also given are names of the members of other committee bodies such as scientific advisory groups.
A glance at the CHMP page shows that the committee has 11 working parties on biologics, blood products, cell-based products, gene therapy, vaccines, pharmacogenetics, pharmacovigilance, efficacy, safety, quality (a joint group with the CVMP) and scientific advice. It also has two temporary working parties on paediatric medicines and similar biological medicines (biosimilars), a number of scientific advisory groups in various therapeutic areas, and three other groups covering relations with patient and consumer organisations, quality review of documents and product names.
The CVMP has six working parties, on efficacy, immunologicals, quality (with the CHMP), pharmacovigilance, safety and scientific advice. It also has a temporary working party on environmental risk assessment and a scientific advisory group on antimicrobials.
New post
Once in place, the EMEA's new senior medical officer will provide advice to the executive director, Thomas Lönngren, and establish and maintain relations with the outside world2. His or her responsibilities will include ensuring good co-ordination among the various scientific committees, resolving any conflicts between them and other EU bodies, and advising the executive director on scientific matters relating to the evaluation of medicines, clinical/preclinical issues and safety matters.
The senior medical officer will also report back on experience gained from EMEA procedures, organise research on the outcomes of the agency's regulation of medicines, and help to identify any bottlenecks in its work. He or she will also represent the agency in outside affairs, such as speaking at conferences and building up relationships with academia and other interested parties.
Access to documents
The agency has also published a new version of its rules on access to EMEA documents, which were first published in 20043. It said nothing had fundamentally changed in the rules, but that they had been slightly reworded, mainly to bring them fully into line with the new EU legislation.
References
1. www.emea.eu.int/whatsnewp.htm
2. www.emea.eu.int/htms/general/admin/recruit/recruitnew.htm
3. www.emea.eu.int/pdfs/general/manage/mbar/6795706en.pdf