Requesting scientific advice from the CHMP can
be sought irrespective of whether the product
licence application will be made using the ‘centra-
lized’ or ‘mutual recognition’ procedures (see
below). For products that are not required to pass
through the centralized procedure (CP), careful,
case-by-case consideration is needed when decid-
ing which authority to approach with a request for
scientific advice.
Scientific advice can be requested on Chemistry,
Manufacturing and Control (CMC), preclinical
testing or clinical development of a medicinal pro-
duct. Regulatory authorities generally require that
the issues raised should not be already covered by
existing guidelines, unless the sponsor wishes to
deviate from published guidance and present a
justification for doing so.
Scientific advice is not, and should not be
regarded as a pre-submission review. The advice
given by the RAs is not binding on either the RA or
the sponsor.
The timing of a scientific advice request should
be carefully planned. The CHMP and national
authorities recommend that scientific advice
requests are best when made early in the develop-
ment of a drug; follow-up questions on the advice
provided and renewal of questions throughout the
development process are possible and encouraged.
Application procedures: scientific advice from
EMEA (EMEA/H/4260/01/Rev. 2)
The role and responsibilities of the Scientific Advice
Working Group (SAWG), within the CHMP are
published. The highly structured, formal procedure
does not necessarily include a face-to-face meeting
between the company and the SAWG, and there is a
substantial fee (unless the IMP is a designated under
theorphanproductregulations,seebelow),although
this varies according to the nature and extent of the
questions on which the advice is sought. In generat-
ing its scientific advice response, the SAWG first
presents a draft response to the CHMP. The final
advice is provided to the sponsor in writing. The
procedure provides for follow-up requests after the
original written scientific advice response has been
issued.
The SAWG is a multidisciplinary group and
comprises a Chair and 17 other members (includ-
ing 2 COMP members). The Chairperson of the
SAWG is nominated by the CHMP for a term of
three years, and is eligible for renomination. The
Chair may or may not be a member of the CHMP.
The Vice-Chairperson is elected by and from
amongst the SAWG members for a term of three
years, again renewable. The CHMP appoints 15
members for a term of three years upon proposal of
CHMP delegates. The SAWG can also co-opt
members from outside the EMEA, from among a
prequalified panel of external experts. The overall
aim is to maintain a comprehensive expertise,
because scientific advice and protocol assistance
(PA) may involve pharmaceutical development,
toxicology, methodology and statistics, pharmaco-
kinetics, other therapeutic fields as appropriate.
The EMEA publishes the panel of external experts,
and this currently includes about 3500 names. The
SAWG meetings are held on each Monday prior to
a CHMP meeting, and these are advertised on the
EMEAweb site. A detailed description of the exact
procedure, and the fees to be paid, can be found in
the Scientific Advice Guidance Document on the
EMEA web site. Applicants should inform the
EMEA Secretariat of the intention to submit a
scientific advice request about two weeks before
the actual submission and pay the required fee at
that time. The final, written scientific advice
response issues by day 90 of the procedure, when
it is formally adopted by the CHMP. The EMEA is
also encouraging informal discussion without fee,
prior to making the official scientific advice
request.
Scientific advice from national regulatory
authorities
Scientific advice from individual national authori-
ties is also available. Applicants contact the
national authority prior to sending the formal
request for scientific advice, and the rest of the
procedure, in most MS, is similar to that in the
EMEA procedure. With less administrative effort
and more frequent presence of key members at the
national authorities, scientific advice at the
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