Directive on clinical trials of medicinal products for human use enters into force
The most recent European Parliament and Council Directive laying down the laws, regulations and administrative provisions of the Member States relating to good clinical practice in the conduct of clinical trials on medicinal products for human use has now entered into force with its publication in the Official Journal of the European Communities. Clinical trials have been a requirement of EU law for medicinal products intended for human use since 1965. Since then, the accepted basis for conducting such trials has been founded in the protection of human rights and the dignity of the human being. This means that, amongst other things, EU law should protect people who are unable to give consent to participation in a clinical trial. The latest Directive, which the European Parliament and Council adopted on 4 April 2001, lays down provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products. It relates, in particular, to good clinical practice. However, it does not apply to non-interventional trials. The Directive applies without prejudice to the national provisions on the protection of clinical trials subjects if they are more comprehensive than the provisions laid down by the Community legislation. These requires Member States to adopt, if they have not already done so, detailed rules to protect individuals unable to give their consent. The official text of the directive describes in detail the rules governing when a clinical trial may be undertaken. And it explains the legal procedure which must be followed for: - clinical trials on incapacitated adults not able to give informed consent; - ethics committees which must prepare opinions before a clinical trial commences; - adoption of single opinions for multi-centred clinical trials limited to the territory of a single Member State; - detailed guidance on the application format and documentation to be submitted in application for an ethics committee opinion; - commencement of a clinical trial; - conduct if a clinical trial; - exchange of information; - suspension of the trial or infringements; - manufacture and import of investigational medicinal products; - labelling; - verification of compliance of investigational medicinal products with good clinical and manufacturing practice; - notification of adverse events; - notification of serious adverse reactions; - guidance concerning reports; - adaptation to scientific and technical progress; - and committee procedures. Member States are required to adopt and publish legislation complying with this Directive before 1 May 2003 with a view to their application no later than 1 May 2004.