BRUSSELS, Belgium ¿ Biotechnology-derived medicines will be subject to additional controls on clinical trials in the European Union if the latest version of proposed new rules passes into law.
The European Commission published a revised proposal for a directive to regulate clinical trials after 18 months of discussion on the earlier draft it produced in September 1997. And one of the key changes in the new text is that details of all new clinical trials in Europe will have to be passed to the London-based European Agency for the Evaluation of Medicinal Products (EMEA), to ensure it has a full register of any trials for biotechnology-related products.
The commission said the reason for this change is to ensure compatibility with existing EU legislation. It said its 1997 proposal risked being less than fully compatible with the principles and objectives of the EU¿s current centralized marketing authorization procedures for medicinal products, under which the EMEA is responsible for evaluating all medicinal products derived from biotechnological processes.
¿It is essential for the agency to know of the existence and content of the clinical trials on such products, as it will have to analyze the relevant clinical data when evaluating the products with a view to granting them a community marketing authorization,¿ the commission said. It therefore is recommending it be mandatory to send the EMEA a copy of the notification of commencement of a clinical trial, so the agency can assess the content in preparation for subsequent evaluation of the product if it should be subject to the centralized authorization procedure.
Elsewhere, the earlier draft directive has been modified principally to speed the start of clinical trials in Europe, by making universal the notification system that already is common in many EU countries, instead of the prior authorization system that still prevails in others ¿ notably Italy.
But biotechnology products are subject to an additional constraint here, too. In the case of clinical trials on medicinal products derived from biotechnology, the new draft says, the notification of the clinical trial must be accompanied by a written authorization granted by the regulatory authorities of the member state (or states) concerned.
This new version of the draft directive now will go back to the European Parliament for a second reading, and to establish whether agreement can be reached in the EU Council of Ministers.