Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

How harmonised are Drug Regulations and Regulatory Decisions in EU and US? Expectation and Reality ***

Sabine Franke (Abschlußjahr: 2011)

Language: English

In the US, the first approaches of modern, state-controlled marketing approval of medicinal products date back to the late 1930's. In Europe, it took another 20 to 40 years before national governments took over greater responsibilities to protect the health of their citizens. The rapid increase in drug laws, regulations and guidelines lead to more divergence between the main pharmaceutical markets, and the need to rationalise and harmonise regulations became increasingly important. In the 1990's the International Conference of Harmonisation (ICH) started at an international level to standardise the scientific aspects in the field of clinical research, the development of medicinal products and their registration in the three regions; US, EU and Japan. Based on this standardisation and the implementation of harmonised ICH guidelines, a reduction in the divergences between the involved regions with regard to their national regulatory requirements was achieved in the last 20 years.

Despite the harmonisation of guidelines over the last two decades and despite the increasing cooperation between the FDA and the EMA in the last years, there are still divergences concerning regulatory decisions. This was demonstrated in the master thesis when comparing the outcome of the licensing of new drug applications and regulatory decisions on existing marketed medicinal products in Europe and US within the last three years.

A large number of discussion forums and publications deal with the differences and commonalities of drug approval and licensing procedures in Europe and the US. The two regulatory authorities - the FDA in the US and its European equivalent, the EMA - are subject to permanent comparison by the public. In this connection, the following questions are usually in the focus:
Which one of the two authorities handle drug approval procedures more quickly?, and: Which one of the two authorities is more or less conservative in decision-making?

However, these questions are not only of importance for the work of the FDA and the EMA. They also are of great importance for globally acting pharmaceutical companies with regard to the development of new pharmaceutical products and for their planning of strategies to obtain regulatory approval in both regions.

Moreover, divergent regulatory decisions may pose questions to health care professionals and patient populations on the reasons why a medicinal product or indication is approved in one region and denied in the other region.

Divergences regarding the non-uniform approaches in the drug evaluation phase have been identified. In addition, differences in how the agencies chose to manage drugs risks and the tools available for doing so, as well as different interpretations of FDA and CHMP guidelines (that are not ICH guidelines) have been outlined in the master thesis. Beside these differences no unambiguous predictors have been identified, which may cause such heterogeneity in the regulatory outcomes in the EU and US.
Therefore, it can be assumed that mainly cultural and economic aspects as well as divergent prescribing and medical practices affect the decision process in both regions.

Pages: 54,
Annexes: 5, pages: 52