New EU Legislation On Clinical Trials

The European Commission has recently adopted a new Directive of importance to companies conducting clinical trials in the EU. The Directive clarifies the definition of "good clinical practice" as used in the EU Clinical Trials Directive. It also specifies the requirements for manufacturing or importing products to be used in such trials, for documents relating to a clinical trial, and for inspectors and inspection procedures. Member States must comply with the Directive by 29 January 2006 at the latest.

In this new Directive the Commission adopts principles of good clinical practice with regard to the design, conduct and reporting of clinical trials on humans. Key provisions state that:

• Available non-clinical and clinical data must be adequate to support a proposed clinical trial;
• Persons conducting clinical trials must be qualified by education, training and experience;
• Clinical trials must be scientifically sound and guided by ethical principles in all their aspects;
• Trial information must be recorded, handled, and stored in such a way as to protect the confidentiality of records of trial subjects; and
• Sponsors of clinical trials are responsible for the conduct of the trials and for data collection from such trials even if they delegate trials-related functions to others.

The Directive lays down the requirements that a company applying to manufacture or import a medicinal product to be used in clinical trials must comply with. They include:

• Specifying the types of products (e.g. biotechnological products, herbal products, and products containing chemical active ingredients), their pharmaceutical form, the relevant manufacturing or import operations, and manufacturing process; and
• Having permanently and continuously at its disposal the services of at least one qualified person as referred to in the Clinical Trials Directive.

The holder of an authorization to manufacture or import products to be used in clinical trials must also, among other things:

• Have at its disposal staff that comply with legal requirements in the Member State concerned;
• Inform authorities of any changes to the information in the application for such an authorization;
• Allow agents of Member States access to its premises;
• Enable the qualified person to carry out his or her duties, for example by providing necessary facilities; and
• Comply with the principles and guidelines for good manufacturing practice as laid down by EU law.

The Directive states that the investigator and the sponsor of a clinical trial must keep essential documents relating to the trial (the "trial master file") for a period of five years. The documents must show whether the investigator and sponsor have complied with good clinical practice and other applicable requirements, including analytical, pharmacotoxicological and clinical standards and protocols. The sponsor must also appoint individuals within its organization who are responsible for, and the only people permitted to access, the archives.

Finally, the Directive imposes a number of detailed requirements on Member States with respect to inspectors and inspection procedures. For example, inspectors must guarantee confidentiality, must receive appropriate training and know the relevant EU and national legislation. Improvement and harmonization of inspection guidance shall be achieved by the Member States, the Commission and the European Medicines Agency (EMEA).