International harmonisation – the need for transparency

Issue title: Secrecy in Drug Regulation

Article type: Research Article

Authors: Hodgkin, Catherine

Affiliations: HAI (Europe), Jacob van Lennepkade 334T, 1053 NJ Amsterdam, The Netherlands

Abstract: International harmonisation of drug regulatory procedures could contribute both to efficiency and to drug safety. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is currently the most important initiative in international harmonisation and will have a major impact on the marketing and regulation of drugs. ICH is organised by the industry associations and the regulatory authorities from the major pharmaceutical manufacturing regions: Europe, the US and Japan. The ICH process focuses on developing technical consensus which should result in guidelines for drug product approval. This paper discusses some areas of concern in relation to ICH paying particular attention to issues of transparency and accountability. Too much priority is given to speeding up the regulatory process and insufficient attention to other potential benefits of harmonisation.

DOI: 10.3233/JRS-1996-9310

Journal: International Journal of Risk and Safety in Medicine, vol. 9, no. 3, pp. 195-199, 1996