Biomedical Engineering Reference
In-Depth Information
The EU is currently composed of 27 member states and a total population of 480 million (com-
pared with 250 million in the USA and 125 million in Japan, the other two world pharmaceutical
markets). The total European pharmaceutical market value stands at €70 billion, representing al-
most 33 per cent of world sales (the US and Japanese fi gures are 31 per cent and 21 per cent respec-
tively). Annual expenditure on European pharmaceutical R&D stands at about €17 billion.
Prominent within the EU organizational structure is the European Commission. The major func-
tion of the European Commission is to propose new EU legislation and to ensure enforcement of
existing legislation. European drug law, therefore, comes under the auspices of the Commission.
Two forms of legal instrument can be issued from the centralized European authorities: a 'regu-
lation' and a 'directive'. A regulation is a strong legal instruction that, once passed, must be imple-
mented immediately, and without modifi cation, by national governments. A directive is a looser
legal term, and provides an individual member state with 18 months to translate the fl avour of that
law into national law. Pharmaceutical law within the EU has been shaped by both directives and
regulations, as discussed later.
4.14.5 National regulatory authorities
There are national regulatory authorities in all European countries. These authorities are appointed
by the government of the country in question and are usually located in the national Ministry of
Health. They serve to apply national and European law with regard to the drug development
process. In many countries, different arms of the regulatory authorities are responsible for author-
izing and assessing clinical trials, assessing the resultant drug dossier and deciding on that basis
whether or not to grant a (national) marketing authorization/product licence. They are also often
responsible for issuing manufacturing licences to companies.
In the past, a company wishing to gain a marketing licence within Europe usually applied for
separate marketing authorizations on a country-by-country basis. This entailed signifi cant dupli-
cation of effort as:
•
the drug dossiers needed to be translated into various European languages;
•
national laws often differed and, hence, different expectations/dossier requirements were as-
sociated with different countries;
•
the time-scale taken for dossier assessment varied from country to country.
Attempts to harmonize European pharmaceutical laws were accelerated in the 1980s. From 1985
onwards, a substantial number of European pharmaceutical directives have been adopted. This
entire legislation has been published in the form of a nine-volume series entitled 'The Rules Gov-
erning Medicinal Products in the European Union' (Table 4.11). These volumes form the basis of
EU-wide regulation of virtually every aspect of pharmaceutical activity.
4.14.6 The European Medicines Agency and the new EU drug approval systems
In 1993, a signifi cant advance in simplifying the procedures relating to drug marketing authoriza-
tion applications in the EU was made. At that time, the legal basis of a new drug approval system
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