Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Requirements for Electronic Expedited Reporting in the European and in the German Legislation with Examples to their Implementation in a Pharmaceutical Company ***

Edith Ueberschaer (Abschlußjahr: 2009)

Language: English

The administration of active substances has not only beneficed effects, but can cause also harm to the treated patients. The figures published by international fore like the WHO or the European Commission show, that the negative effects of medicines are a burden for the Health Insurance Systems of the countries and can even cost human lives. Only a detailed knowledge about the pharmacological properties of these substances, assessed from the very early stages of development can help to minimise risks. Anyway, the continuous monitoring of the risk-benefit balance during the entire lifecycle of a medicinal product is one of the major tasks of a pharmaceutical company. The high-priority goal of the pharmaceutical industry and of the Regulatory Authorities is to provide safe medicines to the patients. Therefore, appropriate legislative measures were taken on different levels.

Beginning with the first Directive released in the European Community in the 60th of the last century, the provisions and rules addressing pharmacovigilance issues became more and more detailed up to now. The challenge for the Member States was to implement these requirements in their legislation. But due to different implementation efforts differences between Member States became evident within the EU and, moreover, heterogeneous rules were established in various regions of the world. In parallel, harmonisation efforts on international level resulted in standards required by an increasing number of Authorities all over the world. The consequence for the pharmaceutical companies was the necessity to have a well functioning Pharmacovigilance System including components, the technical and the procedural one.
Due to the lack of harmonised reporting rules in the EU the safety information reported to the Authorities were often redundant, a correct safety assessment was difficult. The necessity to have consistent safety information to all marketed products has lead to the requirement of the European Commission to create a European Pharmacovigilance Database.
Complex data collection and data assessment activities can be performed within, in order to quickly react if public health is jeopardised.

A rapid data exchange between pharmaceutical companies and the European and national Regulatory Authorities was ensured by using the electronic data exchange tool. This became mandatory in the EEA in 2005. In order to be compliant with this requirement, the databases of pharmaceutical companies should have a compatible interface to the European Pharmacovigilance Database. They must also fulfil the requirements of all Regulatory Authorities of the countries were their products are on the market (inside and outside the EEA). Therefore a SOP system must be available stating internal processes which cover the regulatory requirements of all concerned Authorities.

The reporting of adverse events/adverse drug reaction is not only an obligation of the pharmaceutical industry, but also an important task of healthcare professionals and of the involved patients. Irrespective of the reporting source, or of the development phase of the concerned drug, very strict reporting rules and standards must be adhered to by the pharmaceutical companies.

The data collection is anyway only the first step of the pharmacovigilance activities. The scope of a centralised data collection is the continuous assessment of these data by statistical and epidemiological methods, in order to early detect risks for the public health.
The increasing role of pharmacovigilance is also revealed by the changes of the European legislation with focus on the safety issues. These changes must be implemented in the national legislation of the Member States and will require enhancements of the Companys Pharmacovigilance System as well. Due to the local specificities in the different countries, a lack of harmonisation can result. The challenge for the pharmaceutical companies is, to flexibly react to the changing legislation in order to be compliant with the effective regulatory requirements in all countries of interest.

Pages: 57,
Annexes: 18, pages 50