Principles and Practice of Pharmaceutical Medicine

advisory committee serving the EMEA should be
served by expert panels, covering chemistry and
pharmacy, pharmacology, and toxicology, and
multiple clinical panels of experts, covering for
example cardiovascular, respiratory, diabetic and
endocrine disorders, oncology and so on, on the
pattern used by the US Food and Drug Adminis-
tration (FDA). This would be a way forward, with
synthesis of an overall view done by a standing
expert committee. It would have to be recognized
that not all EU member states would be involved
in every committee or expert panel. Although
attempts should be made to involve all member
states at some level in the procedure, it must be
accepted that, in the public interest, expertise
should predominate over national representation.
The role of selection of the experts to serve on
this standing committee and expert panels should
be the role of the EMEA Management Board, and
nominations should be made by the Ministers of
Health of the member states of the EU, on a
similar basis to the way the membership of the
British Committee on Safety of Medicines is
drawn together.

Possible changes to the decentralized
or mutual recognition system

The current mutual recognition system is cum-
bersome and could be improved. A true mutual
recognition system for marketing applications
that did not involve a NCE could be devised,
drawingonthesystemoperatinginthemedical
devices area, where authorization by one regu-
latory agency leads to an EU-wide approval,
provided that marketing in all EU member states
is identical with the approval granted in the
reference member state. A single chemical entity
MA number would be used to cover the author-
ization in all member states of the EU. Applicant
companies would be wise to select a credible
national drug regulatory authority to process
such a mutual recognition. In fact, it might be
better if the scheme were to designate competent
national authorities to operate such a procedure,
andlaiddownstrictcriteriafordelegatingsuch

authority to competent national regulatory

bodies (not all national authorities would neces-

sarily qualify).

Single assessment/single marketing approval

Both systems, modified as outlined, would lead to a

single EU-wide marketing approval, following a

single assessment.

33.6 Conclusion

The European system for granting MA for medic-

inal products will continue to evolve and change;

however, like the advice given to the man seeking

directions (I would not start from here if I were

you), we do not have an option. Finally, it has to be

understood that the EU is not a country – it is a

collection of member states, and there continues to

be much fertile ground for continuing debate and

dissent.

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