his past year, DIA continued to support the global evolution of regulatory science to increase efficiency through regulatory convergence, and the development of data and submission standards:

• DIA was named Authorized Training Partner of the ICH (International Council for Harmonization), offering ICH-approved courses in alignment with the latest ICH guidelines.

• DIA was named Authorized Training Partner of the ICH (International Council for Harmonization), offering ICH-approved courses in alignment with the latest ICH guidelines.
• Following recommendations from the DIA Council of Regulators (COR), we addressed current regulatory challenges, including ICH training needs and the use of Artificial Intelligence (AI) and Real World Data (RWD) in regulatory decision making.
• As a prelude to China’s official ICH membership announced in June 2017, we successfully collaborated with the China Food and Drug Administration (CFDA) to arrange a joint ICH workshop in conjunction with the 9th DIA China Annual Meeting.
• Several DIA meetings, including the 2017 Joint International Conference on Clinical Trials in Korea, the 14th DIA Japan Annual Meeting, and the DIA 2017 Global Annual Meeting, highlighted the growing role of AI in healthcare and the regulatory approval process.
• We successfully collaborated with India’s Central Drugs Standard Control Organization (CDSCO), FDA, and EMA to host a 2-day USFDA-EMA-CDSCO-DIA Multicenter GCP Workshop in India.
• In Japan, we co-hosted for the first time the 12th Summit of Heads of Medicines Regulatory Agencies and the International Coalition of Medicines Regulatory Authorities (ICMRA).

• Following recommendations from the DIA Council of Regulators (COR), we addressed current regulatory challenges, including ICH training needs and the use of Artificial Intelligence (AI) and Real World Data (RWD) in regulatory decision making.
• As a prelude to China’s official ICH membership announced in June 2017, we successfully collaborated with the China Food and Drug Administration (CFDA) to arrange a joint ICH workshop in conjunction with the 9th DIA China Annual Meeting.
• Several DIA meetings, including the 2017 Joint International Conference on Clinical Trials in Korea, the 14th DIA Japan Annual Meeting, and the DIA 2017 Global Annual Meeting, highlighted the growing role of AI in healthcare and the regulatory approval process.
• We successfully collaborated with India’s Central Drugs Standard Control Organization (CDSCO), FDA, and EMA to host a 2-day USFDA-EMA-CDSCO-DIA Multicenter GCP Workshop in India.
• In Japan, we co-hosted for the first time the 12th Summit of Heads of Medicines Regulatory Agencies and the International Coalition of Medicines Regulatory Authorities (ICMRA).

Why we care: To accelerate the delivery of safe and more efficient therapies to patients around the world, it is essential to advance the tools, standards, and approaches involved in the development, manufacturing, evaluation, and regulation of these therapies. We aims to advance the evolution of regulatory decision-making by helping identify key questions and priorities that exist in today’s global regulatory system.

Established in 2016, DIA’s COR includes regulatory representatives from Canada, Europe, Japan, Korea, Singapore, the US, and the World Health Organization, to help guide our regulatory science strategy and craft tractable solutions to the most important regulatory challenges in healthcare today. In 2017, the COR met on three occasions, providing actionable input on DIA’s solutions agenda for 2017 and beyond. As a result, DIA acted quickly to address both ICH training needs and the continuing regulatory challenges associated with AI, and to engage research institutions and companies in this effort.

The COR also helped lay the foundation for prioritizing regulatory issues with generic drug development and access in response to the latest generic drug user fee reauthorization (GDUFA). To that end, we have recently entered a collaboration with the FDA, which will provide a solid basis for fruitful discussions on quicker access to safe drugs in the coming year. Going into 2018, we will continue to work with the COR on these and other important issues, including the use of RWD in the regulatory process and the approval of abuse-deterrent formulations to stem the opioid crisis.

Our organization strives to build cooperative relationships with national regulatory bodies across the globe. For example:

• Following in Singapore’s footsteps, Korea’s Ministry of Food and Drug Safety (MFDS) has recently opened its doors to us by sending a delegate to DIA COR.
• Representatives from 13 global regulatory bodies attended our 2017 Global Annual Meeting, while 29 countries and their regulatory bodies were represented at the 12th Summit of Heads of Medicines Regulatory Agencies and the International Coalition of Medicines Regulatory Authorities (ICMRA) in Japan.
• The 12th DIA Middle East Regulatory Conference (MERC) brought together regulatory authorities from the Middle East region.

Participants discuss data science in regulatory decision-making, 2017 DIA China Quantitative Science Forum, Beijing

With our wide selection of publications, podcasts, meetings, and training programs, our members are able to navigate the latest developments in the regulatory review process and find answers to questions on drug pricing regulations, biosimilar approvals, safety evaluations of non-opioid alternatives, ICH training requirements, mutual regulatory agreements across regions, and much more.