CDER Conversations
Interviews with CDER experts on priorities, projects, and initiatives
FDA works through ICH to support global drug development: creating harmonized technical standards through guidelines
International regulatory harmonization is increasingly important given the complex, global and diverse nature of pharmaceutical industry operations. Different regulatory authorities often have different scientific and regulatory requirements that drug developers need to meet for product approval. This can lead to duplication of effort, increased costs and time for the developer to bring the product to market, and slower patient access. To address this challenge, FDA engages with other regulatory and industry stakeholders worldwide to harmonize regulatory requirements across regions.
A major part of FDA’s regulatory harmonization effort is undertaken through our work as a Founding Regulatory Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
In this CDER Conversation, Theresa Mullin, PhD, Associate Center Director for CDER’s Strategic Initiatives, talks about CDER’s important work in ICH, providing leadership of key committees and expert working groups, developing harmonized guidelines and related training, and providing expert feedback on guideline development.
Learn more about Theresa Mullin