Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Internet presentation of national regulatory authorities in Europe and Japan

Dr. Beate Ackermann (Abschlußjahr: 2001)

The Internet is an immense network of computer networks not directed by anyone, which enables the free communication between personal computers all over the world. Access is unlimited. Just as other organisations and individuals, regulatory authorities have to decide whether and how to use the immense possibilities of information exchange for their purposes.

In the European Union a medicinal product may be placed on the market of a Member State after a marketing authorisation has been issued by the competent authorities of that Member State or an authorisation has been granted by the European Agency for the Evaluation of Medicinal Products. In Japan, the role of a medicines agency is entrusted to several bodies and structures, which jointly exercise the administration over pharmaceutical affairs. Finally, the approval is granted by the Ministry of Health, Labour and Welfare.

The theme of this master thesis is the Internet presentation of national regulatory authorities in Europe and Japan. For Europe it has been decided to analyse the web sites of the British Medicines Control Agency, the Swedish Medical Products Agency, the French Agency for the Sanitary Safety of Health Products and the Swiss Intercantonal Office for the Control of Medicines. For Japan only those parts of the web sites offered by the Ministry of Health, Labour and Welfare and its associated institutions are evaluated, which deal with regulatory affairs.

The web site of the British Medicines Control Agency is well-structured and outlines the organisation and the objectives of the authority. Its work, the licensing of medicines, the monitoring of the safety and quality of medicines, in particular the task of pharmacovigilance, and the ensuring of the quality of medicines are described. Information about databases, MCA publications and fees is given, application forms, several guidelines and a detailed list of contacts are provided. The Swedish Medical Products Agency presents its codes of statutes on the most important regulatory issues, about 120 SPCs and a detailed list of fees, but gives no general overview over the authority or its work. The web site of the Swiss authority is marked by the direct availability of legislative texts, guidelines, forms and official publications in PDF- or Word-format and databases giving facts on registered medicines. Most of the information presented by the French agency deals not with regulatory affairs topics but centres around health care issues related to reimbursement, drug addiction or other medical themes. The limited information presented by the Japanese web sites is difficult to find for users not familiar with the Japanese regulatory affairs system. Its greatest part is an outdated overview over the approval and licensing system included in the Annual Reports on Health and Welfare 1998-1999.

The web site of the British Medicines Control Agency has a clear concept and structure. The authority offers its services and provides useful information for the potential client. The Swiss agency has a comparable approach. The analysis of the other web sites shows that the authorities have not yet decided how to use the Internet.

In future, the presentation of useful information and the transparency of the authorities will surely increase. The development will depend on several factors including the responsibilities of the agencies, their capacities, their understanding of their tasks and the respective legal background.

Pages: 31