The Generic Drug Cluster is a consortium of top regulatory agencies from around the world that get together to discuss common issues related to the drug approval process in an effort to better understand how each agency approaches various topics. Hopefully, these discussions will result in developing regulatory strategies that reflect the best and most current practices for addressing the issues and will aid in harmonizing regulatory approaches among these agencies. The process appears to be working!
The FDA just released The Generic Drug Cluster Third Anniversary Reflection (here) where it discusses goals and accomplishments over the previous years.
The Reflection outlines contributions and achievements in the following areas:
- Bioequivalence Recommendations,
- In-Vitro and In-Vivo Testing Standards, and
- Evaluation Standards for Complex Parenteral Drugs
Challenges identified during discussions include:
- Increasing Complexity of Submissions,
- Global Supply Chain Disruptions, and
- Multidisciplinary Coordination
Some of the solutions described include:
- Enhanced Technical Understanding Among Regulatory Authorities, and
- Ad Hoc Workshops and Expanded Discussions
Measurable Outcomes and Impact were reported as:
- Informed Decision-Making,
- Improved Regulatory Processes, and
- Global Harmonization and Preparedness
The document further provides examples of each of these points and describes the collective benefits of sharing and discussing the various issues in an open format, which will ultimately lead to improved public health through development and adoption of best practices. For additional information and context, please see the full text of the “Reflection” at the link provided above.
