FDA, Uluslararası Uyum Konferansı’nın Q11 Kılavuzunu kabul etti (İng)
The US Food and Drug Administration (FDA) has announced its adoption of the International Conference on Harmonization’s Q11 guideline on the development and manufacture of biological and chemical drugs.
The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.
FDA received numerous comments on the draft guidance and those comments were considered as the guidance was finalized. After consideration of the comments and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory Agencies in April 2012. The final document provides guidance on approaches to developing and understanding the manufacturing process of the drug substance and provides guidance on what information should be provided in certain sections of the CTD
FDA said three main changes should be noted in the updated Q11 guideline:
- revisions to the introduction and process development sections to more strongly emphasize that purification processes play a significant role in drug substance manufacture
- revisions to the discussion of design space for chemical entities and biotechnological/biological drug substances
- revisions to the discussion of control strategy
At present, FDA, the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labor and Welfare (MHLW) are the three primary regulatory bodies involved in ICH, though others such as Canada use the standards on a voluntary and piecemeal basis.
EMA adopted the Q11 guideline shortly after its release (25 May 2012), and said final mplementation would come sometime in November 2012