Regulatory Information Management 2014

Increasingly regulatory agencies have been launching transparency initiatives to render their marketing application approval decision making process accessible to industry. In particular, FDA, the European Medicines Agency (EMA), the Japan Pharmaceuticals Medical Devices Agency (PMDA), and Health Canada (HC) reviews and assessments of marketing authorization submissions are publicly available. These reviews provide a wealth of information to all regulatory strategists e.g., on agencies’ challenges during their decision-making process, the prevailing regulatory “culture” or how the agencies integrate expert assessments in their decision-making process. A regulatory strategist may use these reviews as supporting evidence for global regulatory strategic planning, starting at inception of a global development project. A case study will be presented to demonstrate how the information contained in reviews of an approved ophthalmic products prepared by PMDA, US FDA and EMA can be used to build strategic knowledge on the regulatory interpretation of the data presented by the applicant. The case study will show examples of how the strategists can use these reviews to shape negotiation and contingency planning throughout development and beyond approval.