FDA, International Regulators Look at Common Challenges, ‘Innovation’

Posted on November 28, 2017 by FDA Voice

By: Lou Valdez, M.S., Dara Corrigan, J.D., and Peter Stein, M.D.

Lou Valdez, FDA’s Associate Commissioner for International Programs

Regulatory experts from around the world, including FDA, gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified medical products.

With “Innovation” as the theme, the Heads of Medicines Summit and the International Medicines Regulatory Authorities (ICMRA) annual meeting in Kyoto, Japan, Oct. 23-27, 2017, provided unique opportunities for us to share and learn about regulatory issues of mutual concern.

The gatherings bring together leadership from selected national medicines regulatory authorities (MRAs), who represent regulatory agencies of varying maturity. This year, regulators from 28 countries attended, along with representatives from FDA, the European Commission, the European Medicines Agency (EMA), and the World Health Organization (WHO).

Peter Stein, M.D., is the Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation and Research

In the AMR arena, the EMA, the Japanese Pharmaceuticals and Medical Device Agency and FDA have taken further steps to align their approaches to the evaluation of antibiotics. In combatting falsified/substandard medical products, MRAs will work with the WHO for its November 29, 2017 release and dissemination of a Global Report on the public health and socio-economic impacts of falsified/substandard medicines.

Peter Stein, M.D., Deputy Director of FDA’s Center for Drug Evaluation and Research, delivered a presentation on the use of real world evidence (RWE) in pre- and post-market activities for new products. Health care communities currently are using RWE to support coverage decisions and to develop better tools for use in clinical practice. And medical product developers are using RWE to support clinical trial designs. Now, MRAs, including FDA, are considering increasing the use of RWE to support decisions on medical products.

Dara Corrigan, J.D., FDA’s Acting Deputy Commissioner for Global Regulatory Operations and Policy

The final day of the five-day event included a symposium that brought together more than 500 regulatory, academic and industry experts from Japan. Dara Corrigan, FDA’s Acting Deputy Commissioner for Global Regulatory Operations and Policy, discussed the need for international cooperation among pharmaceutical regulatory authorities as part of a panel that included members from the EMA, Japan, Canada, and Ireland. The panelists highlighted increased sharing of inspectional results, collaborating on pharmacovigilance needs, and advancing regulatory science.

Summits like this one in October are critical for those involved in the regulation of medical products. The challenges for medicines regulatory authorities are complex, wide-ranging, and global in nature. Regardless of the size of a regulatory authority, many are grappling with issues of shared concerns.

In 2018, these two summits will merge and will be known as the ICMRA Summit. FDA will host the inaugural 2018 ICMRA Summit.

Established in 2012, ICMRA is a high-level, strategic coordinating, advocacy and leadership group of MRAs that provides direction for actions common to many MRAs’ missions and goals. Over time, ICMRA will enable a global framework to support enhanced communication, information-sharing, coordinated crisis responses, and increase awareness of and appreciation for the importance of strong regulatory systems and functions.

Lou Valdez, M.S., is FDA’s Associate Commissioner for International Programs

Dara Corrigan, J.D., is FDA’s Acting Deputy Commissioner for Global Regulatory Operations and Policy

Peter Stein, M.D., is the Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation and Research