December 12, 2018
10-12 September 2018
Heads of Agencies gathered in Washington D.C., USA for the annual meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA) summit. The meeting was hosted by the FDA, with over 80 participants representing 23 Medicines Regulatory Authorities from around the world and representatives from the World Health Organisation.
The Heads of Agencies explored a range of ways to ensure that patients and science are at the forefront of medicines regulation. Discussions took place on global implications of separate clinical trials for children with Medicines Regulatory Authorities (MRA) looking to streamline requirements and how to extrapolate data across populations. There was a moderated discussion around the current state of play and how MRA can work together to ensure strong science and quality in the review of applications and product approvals. A panel discussed the direction the science of drug approvals is taking and explored ways that MRA can better incorporate the patient’s voice into drug development and evaluation. There was moderated discussion tackling how MRA can utilize real world evidence as a complement to traditional randomized controlled trials data, to strengthen the approval process of new drugs and new indications for existing drugs. A panel discussed the paradigm shift and the need for a clear regulatory pathway to facilitate the development of new therapies and regenerative medical products that can be brought to market enabling innovation while ensuring safety, efficacy and quality.
Heads of Agencies also provided direction to progress ICMRA strategic projects, including the innovation project and regulatory preparedness, pharmacovigilance and public communication, and international crisis management collaboration. Reports on the findings and results of some of the work already achieved by the ICMRA working groups have been published on the ICMRA website. Additionally, a call has been published inviting industry experts to work within the ICMRA supply chain integrity working group on system interoperability.
Reports and recommendations on regulatory approaches to innovation, with respect to regulators’ horizon scanning, identification of expertise, and novel approaches to licensing are being developed and further information will be published on the ICMRA website in 2019.