Principles and Practice of Pharmaceutical Medicine

development. This led to the collaborative project
involving Europe, Japan and the USA known as the
‘International Conference on Harmonisation of
Technical Requirements for Registration of Phar-
maceuticals for Human Use’ (ICH). The ICH aims
to provide harmonized guidelines acceptable to
regulatory authorities in all three places.
The ICH process involves participation by both
national regulatory authorities and the pharmaceu-
tical and biotechnology industries. These parties
form Steering Committees which address selected
technical issues. ‘Working parties’ are often used to
prioritize the issues that Steering Committees must
address. Many ICH guidelines have now issued on
matters of drug quality, safety and efficacy. Some of
these have led to everyday working tools, for exam-
ple, the Medical Dictionary for Drug Regulatory
Activities (MedDRA), or the common technical
document (CTD, mandatory July 2003), which is a
guideline for the structure, format and content of
dossiers that are submitted to the regulatory autho-
rities for product license approval.
Within this framework, we provide below an
overview of the current regulatory procedures in
Europe. We address the practical aspects of regulat-
ing drug development, the MA processes and other
activities such as advertising regulations in the EU.

34.5 The European Medicines

Evaluation Agency

The EMEA is an advisory body reporting directly
to the European Commission. It is located at
London. Its structure and responsibilities are
defined by Regulation 726/2004, and these are pri-
marily ‘coordinating the existing resources put at its
disposal by the MS for the evaluation, supervision
and pharmacovigilance of medicinal products’.
The underlying objectives, driving the work of
the EMEA, are to

protect and promote public health by mobilizing
the best scientific resources in the EU;

promote healthcare through effective regulation
of medicines and better information for users
and health professionals;

facilitate quicker access and free circulations of

medicines within the EU;

collaborate in harmonizing scientific require-

ments to optimize pharmaceutical research

worldwide;

develop efficient, effective and responsive oper-

ating procedures.

In pursuit of these aims, and in response to Regula-

tion 726/2004, the main practical tasks of the

EMEA are to

provide MS and the Community institutions

with the best possible scientific advice on ques-

tions concerning quality, safety and efficacy of

medicinal products for human and veterinary use

(note that this does not include medical devices);

establish multinational scientific expertise through

mobilization of existing national resources;

organize rapid, transparent and efficient proce-

dures for the authorization, surveillance and,

when necessary, withdrawal of medicinal pro-

ducts in the EU;

provide scientific advice to the sponsors of phar-

maceutical research;

draw up scientific opinions concerning evalua-

tion of medicinal products or of the starting

materials used in their manufacture at the Com-

mission’s request;

reinforce the supervision of existing medicinal

products by coordinating national pharmacov-

igilance and inspection activities;

improve cooperation between the EU govern-

ment, MS, international organizations and third

countries;

provide assistance on information of medicinal

products to physicians and the public;

create and maintain a European database of

medicinal products accessible to the general

public;

446 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION