This is now the ninth conference in a series of events which have proven of immense international value both to drug regulatory officials worldwide and to the World Health Organization. The ICDRA provides a unique forum where issues of common concern can be debated. I am delighted to see so many officials from such a variety of countries representing near and far regions of the world, and I am confident that your expectations of this Conference will be fulfilled.

Our hosts at the Ministry of Health and the Federal Institute of Drugs and Medical Devices of Germany, have been more than generous in providing such an attractive venue. I appreciate the enormous task that organizing such an event represents. I would particularly like to extend my gratitude to Professor Hildebrandt, Director of the Federal Institute for Drugs and Medical Devices, and all those involved in arranging the Conference, and transmit my thanks to the planning committee for proposing such an excellent and varied agenda which targets so well our immediate interests and concerns.

WHO attaches great importance to the links it has established with national and international bodies. Without intercommunication and teamwork, little can be achieved. WHO is particularly proud of the networks which it has created and built up over time between WHO and drug regulatory officials and experts in so many countries. These provide us with crucial feedback for our public health work and are an important component of the recommendations and guidelines which WHO disseminates to health care professionals and interested parties worldwide.

You are our link with the world “out there”. The world of reality. The world of safety issues and regulation; of access to medicines; of research breakthroughs. Of counterfeiting and internet selling; trade agreements and commercial interests; success stories and tragedies. Only with your valued support can WHO continue in its task of promoting the safety, quality, efficacy and rational use of medicines and vaccines as part of national health and drug policies. Let me address several areas of major importance to WHO.

Alarming news reaches us of the spread of drug resistance, including reports on the failures of antibiotics to elicit a therapeutic response. Resistance is leading to increased deaths and illness, with consequential health expenditure. Many initiatives are now under way in an effort to deal with the multiple facets of this problem, including recent regulatory action to limit the use of antibiotics as growth enhancers in animals. It is thus more urgent than ever to introduce policies that govern the rational use of antimicrobials and to protect those currently available. Your proposals and recommendations will be of optimal importance in guiding WHO in its choice of strategies and in orienting the surveillance and monitoring systems which it has helped to set in place.

During recent years, tragic events have been reported to WHO concerning the sale of counterfeit or adulterated medicines and the contamination of starting materials used in the production of pharmaceuticals. Many developing countries are wholly dependent on the importation of starting materials for use in the local production of essential and generic medicines. We hope that you will support us in our efforts to improve trading practices, including the extension of national drug regulatory responsibility and inspections to free ports. This action will avert any further incidents associated with the use of substandard medicinal products.

The assessment of multisource/generic pharmaceutical products prior to marketing forms an extensive part of regulatory work. WHO continues to promote the principle that generic products must conform to the same quality, safety, and efficacy standards as the innovator product. To assist drug regulatory authorities in this, WHO has developed guidelines on bioequivalence testing and guidance regarding in vivo studies. Preparations are under way to finalize a list of comparator products that we hope will become valid internationally for equivalence testing. This should decrease the need for repetitive human studies.

The value and uniqueness of the internet as a worldwide communications system is undisputed. However, as all of you who attended the Conference in 1996 may remember, problems involving cross-border sales of medical products using the internet were becoming a matter of serious concern at that time. As a result of your recommendations at that Conference, WHO and Member States were able to work together to find ways to improve the situation.

The World Health Organization has an explicit constitutional responsibility to promote normative initiatives directed towards international harmonization within the health sector and in particular with regard to pharmaceutical, biological and similar products. The agenda has been planned to provide information on the latest ICH developments while allowing discussion of the impact and applicability of this initiative in different parts of the world.

While deliberating on the technical and scientific areas of this core work, we must not lose sight of the challenges that lie ahead. In parallel with its normative work, WHO is committed to strengthening national drug policies and the concept of essential drugs, and promoting the value of prevention and immunization.

Together, we must strive for the full utilization of our scientific and technical advances to the betterment of all countries, developed and developing. We must define how technology can be delivered to the less fortunate, while ensuring that all populations are the recipients of quality health care and delivery. Our past successes have now become the building blocks of the new millenium, through which the promise of health for all will become a reality.