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 authorizing 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 significant duplication 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 associated 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 Governing 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.

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