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The advisory process for anticancer drug regulation: a global perspective.
A T Farrell1, I Papadouli, A Hori
1United States Food and Drug Administration, Center for Drug Evaluation and Research Office of New Drugs, Office of Oncology Drug Products, Division of Drug Oncology Products, Silver Spring, MD 20993, USA. farrella@cder.fda.gov
Summary
Regulatory bodies worldwide utilize external experts for oncology drug development and approval. The specific roles and transparency of these advisors vary by region, reflecting diverse needs in global drug regulation.
Area of Science:
- Oncology
- Drug Development
- Regulatory Science
Background:
- Oncology drug development and regulation require specialized expertise.
- Regulatory agencies globally face challenges in drug approval processes.
Purpose of the Study:
- To summarize the role of external advisors in oncology drug development and regulation from a global perspective.
- To compare the utilization of external expertise across different regulatory jurisdictions.
Main Methods:
- A meeting was held with representatives from major regulatory bodies including the US FDA, EMA, PMDA, TGA, and Health Canada.
- Presentations and discussions focused on the role of external advisors in oncology drug development and regulation within each jurisdiction.
Main Results:
- All discussed regulatory bodies utilize both individual experts and formal advisory groups for external input.
- Individual experts are used variably, from advising during development to reviewing submitted clinical trial packages.
- Advisory boards, common in all jurisdictions, address specific applications and broad policy issues, with non-binding recommendations.
Conclusions:
- Global oncology drug development and registration processes involve regulatory authorities engaging external experts.
- The types of experts, their roles, and the transparency of advisory processes are tailored to regional needs.