POLICY & REGULATION
moves of this nature to come through. The situation with national procedures
In our day-to-day work, we are regularly (mutual recognition procedures and
confronted with regulators’ different decentralised procedures) is becoming
opinions on, among other things, the critical. In principle, one member state
appropriate design, choice of endpoints, could carry out the primary assessment
duration, size of safety database, and that was previously done by 27 countries
post-approval conditions for development individually. But instead, even with work-
programmes. The EMEA/US FDA joint sharing and other initiatives, we have a
scientific advice procedure must be flawed situation, including a slot system
revitalised to ultimately become a regular with waiting times for submission of
procedure for major new products, marketing authorisation applications of up
including advanced therapies, with the to two years in the most popular member
objective of reaching a joint agreement. states. EU regulatory systems based on
Similarly, harmonisation activities should the principle of mutual recognition have
be initiated to arrive at joint positions on been successful in many other fields, but in
what constitutes a clinically-relevant effect, pharmaceuticals the track record is
beginning with major areas of therapeutic not good.
research. The EMEA has recently launched a
project aimed at improving the assessment
of benefit/risk profiles of new medicines. A
EU regulatory systems based
structured list of benefit and risk criteria is
to be identified and used in a pilot testing on the principle of mutual
phase. In this context it will be necessary
recognition have been successful
to clearly define what constitutes a clinically
relevant effect in the specific condition
in many other fi elds, but in
investigated in order to make the proper
pharmaceuticals the track
judgement of acceptable risk. Leading
record is not good
European clinical experts need to be
invited to participate in such deliberations.
This work is also very important in
light of criticism that medicines are being Successive regulatory reform (which
authorised, but not recommended, for has about a 10-year cycle) has at each
use in the healthcare system. In order stage since the 1960s moved away from
to make the difference between clinical harmonisation as a desired outcome
benefit/risk and societal benefit/risk (cost) to harmonisation as a legal imperative.
understandable to laymen, politicians For example, note the move from the
and media, it is absolutely critical for the (unrealised) expectation of mutual
responsible authorities to convincingly recognition in the MR procedures from
outline the criteria used for arriving at the 1970s and 1980s to a compulsory
decisions that on the surface may look centralised procedure for NCEs in many
antagonistic, but which are still correct important therapeutic areas today. The
considering the different remits. move towards increasing centralisation
In terms of the regulatory environment is inexorable and necessary. Many of our
in general, we do not believe that the clients tell us that what was unthinkable
system we have today is sustainable. Yet before – a European drugs agency handling
we fully agree with the widely held view all regulatory assessments – would be a
that the EMEA has been a success story. welcome relief.
The agency’s procedures are by and large Another challenge is making newly
transparent, predictable, and well managed, authorised medicines available to patients.
and they provide opportunities for At a recent conference, a representative
appropriate dialogue with industry including from one of the new accession member
the provision of scientific advice. states made an excellent point: why
Today about 50% of centralised MAAs should their regulatory agency volunteer
have previously received scientific advice, to be the rapporteur or co-rapporteur
helping sponsors avoid some of the most in the centralised procedure leading to a
common problems, such as choice of marketing authorisation valid throughout
dose, choice of endpoint and choice of the whole of the EU, when almost none of
comparator. But we are also concerned that the new chemical entities authorised by the
the political need for all member states to centralised procedure had been marketed
be “at the table”, combined with the almost in their country? This problem will likely
ad hoc creation of committees, may easily take longer to solve than rationalising
create a situation in which administrative the EU procedures.
bureaucracy takes more resources than
what is really important – informed
scientific regulatory debate leading to Pete Chan is editor of the Scrip 100.
sound opinions.
www.scripnews.com/supplements Scrip 100
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