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
 

Report on WHO Monitoring Group on Gene Therapy

Dr Hongki Min, WHO

In 2002 the WHO Expert Committee on Biological Standardization (ECBS) recommended that the WHO secretariat monitor progress and consider developing guidelines for gene therapy products, along the lines of the existing guidelines for assuring the quality of DNA vaccines.

In response, a WHO Monitoring Group on Gene Therapy was formed with the objectives: to monitor developments in gene therapy and assess the need for international reference materials; to consider nomenclature of gene therapy products and to provide advice to the WHO Committee on International Nonproprietary Names; to consider development of appropriate guidelines.

The Group proposed that it be renamed as the WHO Clinical Gene Transfer Medicinal Products Monitoring Group, and that it should deal with all such products currently being developed for use in or on humans either for therapeutic purposes or for prophylaxis. In order to understand better the needs of countries outside Europe and the USA, it was recommended that WHO convene a meeting on the state of development of gene therapy products and regulatory oversight, with participants from all regions.

Future action will include monitoring the development of gene therapy products and developing guidelines for assuring their quality, safety and efficacy in harmony with existing guidelines and requirements. Standards, reference materials and assays for relevant products should be developed, and educational sessions organized for scientists and regulators in clinical gene transfer.

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