BioWorld International Correspondent
BRUSSELS, Belgium - Tougher European drug safety monitoring rules are coming, and likely will include post-authorization safety studies.
European Commission Vice President Günter Verheugen, the senior European Union official responsible for medicines, promised to "improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected and effectively dealt with on the basis of more robust data."
There will be, for the first time, a clear legal requirement to conduct post-authorization safety studies. The plans include wider and faster access to drug safety data, standards of good vigilance practices, harmonization of national reporting and evaluation procedures, a bigger coordinating role for the London-based medicines agency and European studies in medicine safety and pharmacovigilance methodologies.
An extensive analysis of pharmacovigilance practices in Europe over the last year has convinced officials that the current EU legal framework is excessively complex, with diverse reporting requirements for the industry across the 27 member states. They say roles and responsibilities need clarifying.
Verheugen claimed that "rationalization of the EU medicines safety system will free up resources, which can then be directed to better protecting the health of EU citizens." During the rest of this year, officials will conduct an assessment of how the envisioned changes will impact the industry and regulators, prior to coming up with a legal proposal in 2008.
The European biotech industry association, EuropaBio, already made clear its views on how European pharmacovigilance rules should be modified. It wants to see an end to the current lack of procedural and legal clarity in Europe, with divergent national reporting procedures, interpretations and evaluations. In a submission to the EU, it said the new rules should take into consideration particular concerns of the biotech industry, such as the innovativeness of its products and complexity of their production. It favors a single European-level database of adverse event reports to reduce unnecessary duplication.
"The Biotech industry is interested in contributing to establish and maintain an international living database and/or library containing pooled safety datasets specific for biotech products or of specific relevance to such products," the industry organization said. "Such datasets can be very useful to regulators and individual companies to support investigation of potential specific safety signals with individual products or groups of products. Since the biotech industry is characterized by a significant proportion of small and medium-sized companies, direct access to such pooled datasets may be of particular interest."