Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Close this folderOpening ceremony
View the documentMr Xiaoyu Zheng, Director-General, State Drug Administration, China
View the documentDr Yasuhiro Suzuki, Executive Director, Health Technology and Pharmaceuticals, World Health Organization, Geneva, Switzerland
View the documentDr Eng-Kiong Yeoh, Secretary for Health and Welfare, Hong Kong Special Administrative Region, China
View the documentProfessor Alfred Hildebrandt, Chair of the Ninth ICDRA, Germany
View the documentDr Margaret Chan, Chair of the Tenth ICDRA Director of Health, Hong Kong Special Administrative Region, China
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Professor Alfred Hildebrandt, Chair of the Ninth ICDRA, Germany

As Chairman of the Ninth ICDRA, held in Berlin in April 1999, allow me to extend my thanks to the organizers of this Conference and to the authorities of the People’s Republic of China and the Hong Kong Special Administrative Region, as well as to WHO for inviting me to speak on behalf of my colleagues in Germany.

The Tenth ICDRA, like the Ninth, takes place in a very distinguished city. Hong Kong and Berlin have each undergone historic changes during the past decade. Hong Kong has attained the status of Special Administrative Region, while Berlin has become an undivided city. Following Germany’s reunification, and recognition of Berlin as the capital, the Federal Institute for Drugs and Medical Devices was transferred from Berlin to Bonn, the former provisional capital of Germany, where a new institute has been built.

It sometimes appears that changes are the rule rather than the exception. Such changes underscore the challenges of organizing the ICDRA in one’s own country and demand reflection on the impact that this had on us in Germany. With respect to the benefits, I would choose: reward, enlightenment and challenge. Reward has come from the attendance in Berlin of participants from over 120 countries at an internationally-relevant and purposeful event. This reward continues today and, as an expression of Germany’s continued engagement in the ICDRA process, our representatives are privileged to contribute to the Tenth ICDRA here in Hong Kong as moderators and speakers. Enlightenment has come from the recognition that public health policy must be more than just an extension of national or European policy, that WHO has an explicit constitutional responsibility to promote international harmonization within the health sector, and that the ICDRAs provide a means to do so. The challenge is the engagement to guarantee quality medicines to populations, especially children and patients with rare diseases, in a world with increasingly interlinked economies, and to consistently search for added value within the best quality parameters.

What do we then bring from the Ninth to the Tenth Conference? Looking at the agenda of this meeting, many topics are closely linked to those discussed in Berlin. If we compare the programmes of the Ninth and Tenth ICDRA, some changes are easily recognizable. For instance, herbal medicines, counterfeit drugs, access to drugs and vaccines, and regulatory challenges have become more prominent. These choices reflect a local or regional emphasis on broadly important problems, justifying WHO’s well considered philosophy to hold the ICDRA in a different continent each time, in order to reflect and support such multiple perspectives.

I am certain that all these topics will be well taken care of by the hosts and organizers of this meeting, by WHO, and by all participants, so that when we leave we will have once again been rewarded, enlightened and challenged.

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