The mission of the group will be to ensure that there is sufficient
coordination between the committees, so that the standards they set for the
development of medicines are consistent across the whole product life-cycle,
for increased robustness and predictability of benefit-risk assessment.
The Agency’s Executive Director, Guido Rasi, said: “The current system of
scientific committees, their working parties and other advisory groups has
become increasingly complex. We now have six scientific committees, plus two
scientific advice working parties, one for human, one for veterinary medicines.
Soon, in July 2012, we will see the establishment of a seventh committee, the
Pharmacovigilance Risk Assessment Committee (PRAC). The complexity of the
system has increased to a point where we have to ask ourselves if it is still
fit for purpose. We have set up this new group so that we can analyse together
the working methodology of the system so far, identify weaknesses or gaps in
the system and discuss ways to address these.”
The group, which is chaired by the Agency’s Executive Director, is composed
of the chairs of the Agency’s scientific committees, the scientific advice working
parties and relevant senior management staff from the Agency’s secretariat.
Following a first preparatory meeting in January 2012, the group has now been
formalised. It will meet four times a year. Its mandate is to come up with a
vision that integrates the expertise of all of the Agency’s committees into one
common framework. The group will not deal with any issues related to specific
medicines.
In addition to the challenges of coordinating a growing number of
scientific committees with different roles, the group will also look at other
factors that are putting the system under pressure. These include: increasing
difficulties in sourcing appropriate experts due to the continuous
strengthening of the rules on allowable conflicts of interests of the Agency’s
experts; the continuous increase in the number and level of activities for all
committees; and finally, challenges from new scientific developments, for
instance advanced therapies or personalised medicines, which require an
integrated scientific and regulatory approach, from the drug development phase,
starting with scientific advice, right through to post-authorisation follow-up.
Notes
- The Agency has at present six scientific committees: the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the Committee for Orphan Medicines (COMP), the Committee on Herbal Medicines (HMPC), the Paediatric Committee (PDCO) and the Committee for Advanced Therapies (CAT). The Pharmacovigilance Risk Assessment Committee (PRAC), the seventh committee, will be established in July.
- The increasing complexity of coordinating a growing number of scientific committees and their associated working parties was already highlighted in a 2010 report on the evaluation of the European Medicines Agency, conducted by Ernst & Young.