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.