EU Drug Regulation And The Needs Of Industry

In the last few years the opportunities presented to pharmaceutical companies to get to grips with the developing European Union regulatory environment have not largely been taken up, says a new study from Financial Times Management Reports, Pharmaceutical Regulation In Europe. Author Paul Evers says that in June 1993, the UK Medicines Control Agency estimated that over 90% of new product registration applications involving new active substances and over 95% of abridged applications were still using national rather than EU procedures.

This is largely due to the problems of working with the EU procedures which preceded the "future systems," particularly the multistate procedure and, to a lesser extent, the concertation procedure. In theory, the new centralized and decentralized procedures offer major improvements, says the study, with clearly defined routes towards definite endpoints which generally avoid the open-endedness complained of in the earlier procedures. The new processes produce legally-binding decisions and, with the centralized procedure, the path towards that decision permits little deviation or procrastination.

The study goes on to consider how the new procedures will meet the needs of research-based drug firms. These companies need a market environment into which they can introduce new and (especially) innovative products, receiving marketing authorization within a reasonable timeframe, preferably benefiting from simultaneously valid approvals in all EU countries, and with regulatory processes that are not excessively bureaucratic. Also, almost all these companies have portfolios of established products which they want to support in the regulatory sense without incurring an excessive bureaucratic burden in areas such as post-marketing surveillance.