How Should a Globalized CTD Be Created? An Introduction to the Japanese 3-Layer Approach

This article is based on the consensus of a task force of the Data Science Expert Committee, Japan Pharmaceutical Manufacturers Association. Common Technical Documents (CTDs) need to be harmonized in all of the ICH regions to enhance the scientific value and efficiency of these documents. Region-specific CTDs often require modifications for submission in different countries—an urgent issue not only for Japan but also for the countries where participation in the ICH framework will expand. CTDs themselves should be globalized, which means they should use not only a common format but also common contents, by incorporation of a 3-layer approach. In layer 1 of this approach, efficacy and safety of a study drug are evaluated through the overall study results; layer 2 entails evaluation of whether there is inconsistency in efficacy and/or safety of the study drug for a specific subgroup with overall results; and in layer 3, the results of layers 1 and 2 are used to evaluate benefits and risks in each applying country. The 3-layer approach can be used to create a globally common model using data collected in all countries in the study. This global evaluation allows benefits and risks to be evaluated in all countries and should allow globalized CTDs to be developed. Alignment between research and development sites by pharmaceutical companies and success of regulatory conventions can reduce the total amount of review time. Ultimately, these changes would lead to faster approval o...
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Tags: Global Perspective Source Type: research