BRUSSELS, Belgium - When the steering committee of the Europe-inspired International Conference on Harmonisation (ICH) on regulation of pharmaceuticals meets again next month, it will consider whether to introduce a topic into its compendium of guidelines: harmonization in gene therapy.
ICH sources told BioWorld International the risk of divergent biotechnology regulations developing in the world's major markets for medicines have pushed this item up the ICH agenda. Maintaining and extending international cooperation on biotechnology was identified as a key goal at a recent senior meeting of officials and industry from Europe, Japan and the U.S. at the European Medicines Evaluation Agency.
ICH, a cooperative effort between drug regulators and drug companies around the world, has developed a wide range of standardized guidelines for drug development and testing over the 10 years of its existence - including many in the field of biotechnology-derived products. But there is at present no consensus position on the development of gene therapy products. If the steering committee - consisting of top officials from regulatory agencies and pharmaceutical industry associations - agrees to move the topic ahead next month, it could appear on the agenda of the Nov. 9-11 Fifth ICH Meeting (ICH5) in San Diego.
Meanwhile, ICH says it expects to release this summer a consultation version of the "Common Technical Document" it has been working on for two years, which will be showcased at ICH5. This document is intended to provide a standard format for all marketing authorization applications for medicines, so that one application file will serve worldwide. It also is being designed for generation and transmission in electronic form.