World harmonization of drug approvals

There is a growing trend in the global pharmaceutical industry towards internationalization. Increasingly, mergers and other strategic alliances are a feature of world pharmaceutical activity. Many companies are developing drugs that they aim to register in several world regions. Differences in regulatory practices and requirements in these different regions considerably complicate this process.

Development of harmonized requirements for world drug registrations would be of considerable benefit to pharmaceutical companies and to patients, for whom many drugs would be available much more quickly.

The International Conference on Harmonization (ICH) process (of technical requirements for registration of pharmaceuticals for human use) brings together experts from both the regulatory authorities and pharmaceutical industries based in the EU, USA and Japan. The aim is to achieve greater harmonization of technical/guidelines relating to product registration in these world regions, and considerable progress has been made in this regard over the last decade. The 'members' comprising the ICH are experts from the European Commission, the European Federation of Pharmaceutical Industries Association, the Ministry of Health and Welfare, Japan, the Japanese Pharmaceutical Manufacturers Association, the FDA and the Pharmaceutical Research and Manufacturers of America. The ICH process is supported by an ICH secretariat, based in Geneva, Switzerland.

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