On April 3, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released guidance clarifying its fundamental outlook on determining “competing products” during drug regulatory reviews. The guidance is intended to promote the integrity and fairness of the drug review process given the possibility of conflicts of interest for both applicant companies and their drug competitors. Drug developers are now required to include a “list of competing drugs” in their drug regulatory applications. Competing products are those expected to compete with the new drug when marketed or those that could be affected by the approval (for example, taking a percentage of sales of an existing product’s market share).
The PMDA’s guidance, which was released by the Center for Product Evaluation, indicates that competition will be assessed based on comprehensive considerations that may include indications, pharmacological actions, chemical structure, intended use, and sales data. Products with overlapping indications, despite any difference in their mechanisms of action, could be classified as competing products, too. The PMDA provided criteria and prioritization methods to facilitate consistency and transparency in the assessment. This guidance was conceived in response to Industry requests and continues the Agency’s commitment to ensuring a level playing field in Japan’s drug regulatory decision-making.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.