Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach

Conclusions: It is important to explain the scientific rationale for the control strategy, design space, and real-time release in the QOS and how "regulatory flexibility" is expressed in the AF. The QOS checklist enables applicants to prepare an appropriately detailed QOS that should satisfy the PMDA’s critical review points. The following are recommended for further discussion topics to enable efficient and consistent review by the PMDA for QbD products: (1) Clear guidance on how to express "regulatory flexibility" in the AF and (2) a "QOS checklist for QbD products" that is agreed upon by both regulatory agencies and pharmaceutical companies.
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Tags: Global Perspectives Source Type: research