Masterarbeit

Pharmacovigilance Critical Assessment of Current Regulatory Issues with Special Regard to Urgent Safety Restrictions ***

Dr. Roland Kröger (2003)

Pharmacovigilance, or the surveillance of the safety of a medicinal product during its life on the market, has been extensively improved by a number of new regulations in the last decade. One building block in the framework of these regulations are USRs, which are defined in Article 2 of the Commission Regulation EC/ 2309/ 93 as an interim change to product information by the MAH by restricting the indication(s), by altering the dosage of the medicinal product, by adding a contra-indication, and/ or by warning due to new information having a bearing on the safe use of the product.

After an overview of the current regulation regarding Pharmacovigilance in the European Union, the present thesis describes the impact of the new variation regulations on USRs, which will go into effect on 1 October 2003. This is done by analysing some examples of recent USRs and by discussing the impact of the new regulations on them. These new regulations are expected to be an important improvement to the strengthening of the pharmacovigilance processes and a favourable effort to ensure the safety of medicinal products. The major goal of improving the public health will thereby be served.

In addition, the paper reflects this effort in the light of the main challenges of the next ten years for industry, regulatory Authorities, and the public which include the enlargement of the European Union and the increasing expectations of consumers. With this in mind the pharmacovigilance systems have to be continually improved. This should be done by further harmonisation of current regulations and by an intensive information process of patients with their medical advisors. Presently these needs are not sufficiently fulfilled. However, there are some interesting initiatives concerning the introduction of Good Pharmacovigilance Practices, and efforts to realize these proposals are a way to ensure public health on a higher level. Therefore, the current improvement of the USRs with its main focus on expediting and strengthening of the procedures is only one step along this way.

Pages: 29