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
Close this folderRegulating biotechnology products
View the documentComparability of biotechnology products and cell substrates
View the documentAssessing biocomparability: a Canadian perspective
View the documentRegulatory aspects of nucleic acid vaccines
View the documentReport on WHO Monitoring Group on Gene Therapy
View the documentRegulating biotechnology products: Cuban experience
View the documentRegulation of products derived from recombinant DNA technology in China
View the documentRegulation of biotechnology products in the Republic of Korea
View the documentRegulation of biotechnology products in Indonesia
View the documentRecommendations
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
 

Regulating biotechnology products

Moderators: Dr Lucky S. Slamet, Indonesia, Mr Mark A. Elengold, USA

Biotechnology, including DNA technology, has opened up new and promising opportunities for the diagnosis, prevention and treatment of diseases through, for example, the provision of safe and effective drugs and vaccines, as well as sensitive diagnostic tools. However, the use of these biological substances raises concerns about safety and quality, resulting mainly from the novel processes used in manufacture and the complex structural and biological characteristics of the products themselves. It is therefore important to ensure that control measures are in place to ensure the quality of the manufacturing process and of its products and to safeguard recipients against possible adverse events.

This session looked at balancing the risks and benefits of biotechnology products through regulation based on international or global standards and norms, while not limiting development or use. Regulation that is comprehensive but simple to implement is particularly important for developing countries, where the technological base is limited and expertise may be less specific. Issues related to the comparability of biotechnology products, including those related to scale-up, were highlighted as needing particular attention.

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