ICH – International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
The ICH harmonized tripartite guideline: "Good Clinical Practice: Consolidated Guideline" has been developed by an ICH Expert Working Group and has been subject to consultation, in accordance with the ICH process, by regulatory parties which include Canada. The ICH Steering Committee has endorsed the final draft and recommended its adoption by regulatory bodies of the European Union, Japan, and the USA.
The Therapeutic Products Directorate of Health Canada has adopted this international guideline in order to define the roles and responsibilities of the Investigator and Sponsor, preparation of the Investigator’s Brochure and Clinical Trial Protocols according to international standards, and to define the Investigator’s and Sponsor’s responsibilities regarding the development, filing and maintenance of ‘Essential Documents’ are unequivocally understood and followed.
ICH GUIDANCE MAKES RECOMMENDATIONS FOR COMPARABILITY STUDIES
The FDA has released an international draft guidance to help makers of biological and biotechnological drugs design studies to assess the comparability of products before and after changes are made to the manufacturing process. Such studies determine whether a manufacturing change adversely affects the quality, safety and efficacy of the product.
The draft guidance, issued by the International Conference on Harmonisation (ICH), provides general principles for the design and conduct of studies used to compare quality attributes - molecular or product characteristics that can be used as quality indicators - of prechange and postchange products.
The guidance, "ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Change in their Manufacturing Process," published in the Federal Register. Comments on the guidance are due May 19.
