Today, more than 90 per cent of the world's pharmaceutical research capability lies within the three member regions of the International Conference on Harmonization (ICH) initiative - Europe, the United States, and Japan. As this tripartite harmonization process grows and takes shape, it is bound to have an influence on drug regulation in many parts of the world. Thus far, the ICH has been highly successful and we would like to see it continue to develop. However, this can only come about if the ICH is shown to be acceptable and of benefit to all countries. We have been fortunate to have WHO, EFTA and Canada as observers at our working groups, and each has provided us with a valuable viewpoint.

Humankind has come to rely on the continued development of innovative drugs to control those diseases which it considers a threat and it cannot be denied that many effective therapies are now available. However, people are still suffering from serious ailments such as cancer, AIDS and the auto-immune diseases for which we still do not have an effective remedy despite our advanced technology. Thus, it is essential to foster research and development of new drugs for the twenty-first century and to come to terms with resurging or new life-threatening diseases. I believe that the developed countries - such as those within the ICH - should shoulder the primary responsibility for undertaking this research and development

The ICH has a number of harmonization objectives, but its main achievement is the tripartite agreement on mutually acceptable requirements, definitions and guidelines. This focus on harmonization of requirements will reduce waste of precious resources by drug regulatory authorities during the approval and inspection process and eliminate repetitious studies needed, until now, to demonstrate safety requirements which differed from country to country. Harmonization will also have the effect of facilitating regulatory communication. Another important ICH goal is to improve the availability of safe and efficacious drugs of good quality to patients, and to ensure that future needs are met. The principal purpose of the ICH is therefore to contribute to the health of the world's populations through the harmonization of requirements.

ICH 3 was held in Yokohama in 1995, and was hosted jointly by the Japanese Pharmaceutical Manufacturers Association and the Ministry of Health & Welfare of Japan. The conference extended a welcome to a large number of participants from many countries, and served not only to publicize ICH achievements but also to ensure the transparency of its procedures. The six members reiterated their commitment to the harmonization process, and the need to advance harmonization beyond the three areas was stressed. It was evident that the role of extending harmonization globally was most fitting for WHO. The Director-General of WHO, speaking at the conference, pointed out that more than 170 WHO Member States remained outside the ICH initiative and he confirmed that WHO is prepared to assist in extending the benefits of the ICH process, where appropriate, to the full complement of WHO Member States.

As regards progress in producing the ICH guidelines, five have now reached the step 4 implementation stage and six have reached the step 2 formal consultation stage. The most visible products of the ICH process are, of course, the 19 harmonized guidelines which have now appeared in published form. It is most valuable to us to know how they are used, and the contribution they are making to harmonization. We therefore conducted a survey among 125 drug companies in the three regions. The results were rewarding and showed that the guidelines were being used at different levels in all companies. Guidelines on drug quality, particularly the guideline on stability testing, are popular and are resulting in harmonized working procedures.

The standards which are being set will not only reduce the need for repetitive studies but will also improve their quality. In this respect, the ICH good clinical practice guideline sets out the ethical and scientific standards required for the mutual acceptance of clinical data. Sponsors of clinical trials must abide by the guideline in order to provide data which is acceptable to other regions. Observance of the terms of the guideline will ensure the quality of the trials and benefit the protection of human rights. Furthermore, improved communication between regulators will bring about result sharing and this will improve the quality and efficiency of the review process and ultimately lead to joint reviews and mutual recognition of approval. We strongly believe that through enhanced research and development and improved regulatory review, drugs developed in the future will meet high standards to the benefit of all concerned.

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