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
Open this folder and view contentsOpening ceremony
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
Close this folderAccess to drugs and vaccines I
View the documentGeneric medicines: old problems and new challenges from a European perspective
View the documentAccess to quality pharmaceuticals: the Indian experience
View the documentQuality of starting materials for drugs and vaccines
View the documentFixed-combination medicines: an Australian perspective
View the documentDrugs for neglected diseases: challenges for regulators
View the documentRecommendations
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
 

Recommendations

1. WHO should continue its efforts in strengthening international guidelines for registration of generic drugs.

2. In collaboration with Member States, WHO should continue to focus on activities related to good trade and distribution practices of starting materials to assure the use of high quality materials.

3. WHO should work with other technical partners, within the concept of a global alliance, to improve the quality of products moving in international commerce.

4. WHO should establish a pre-qualification quality assurance system for essential medicines.

5. WHO should continue its prequalification project for procurement of medicines for priority diseases.

6. In collaboration with Member States, WHO should develop additional international guidance on important elements of combination medicines focusing on rational use to maximize the benefit in specific disease treatment.

7. Governments and drug regulatory authorities should encourage the development of therapies for neglected diseases through incentives, co-operative efforts and public/private initiatives.

8. Progress should be reported back to the ICDRA.

 

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