Five-year re-evaluation of marketing authorisation:
not a simple formality
The need to
re-evaluate new drugs was underlined by the EU Parliament and endorsed
by EU health ministers. Several countries question the need for
a second re-evaluation after 10 years, favouring a single re-evaluation
after 5 years on the market. One country proposed routine re-evaluation
at 5 years and a further re-evaluation 5 years after any change
made to the licensing terms for pharmacovigilance reasons; this
seems to be a reasonable compromise.
However, the
conditions of this re-evaluation are still too vague. If it is not
simply to be a matter of administrative formality, rapporteurs must
have sufficient time to analyse the scientific data. They must also
take into account all new data that accumulate during the first
five years on the market, and not only those offered by the marketing
authorisation holder. The Agency must conduct a thorough data search
of the international literature and the databases of other national
medicines agencies and health technology assessment bodies. All
clinical trials conducted after initial granting of marketing authorisation
("phase IV" trials) must be taken into account (whether
or not they were initiated by the licence holder), and especially
trials comparing the new drug with a reference treatment.
Article 13-1a
must be modified accordingly; once again, these points are in no
way simple "details". Recital 29 must also be more explicit
on this matter.
©La revue Prescrire for the Medicines
in Europe Forum 1 March 2003
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