Global regulators celebrate 10 years of strategic leadership and cooperation

News Category: Regulatory news

Date: 09/11/2023

HPRA one of eight regulatory authorities that came together in 2013 to form the International Coalition of Medicines Regulatory Authorities (ICMRA)

This year marks the 10th anniversary of ICMRA which was established in December 2013 to address a need for a global governance mechanism and stronger cooperation. Today, ICMRA consists of 38 members, with the World Health Organization as an observer. ICMRA is currently chaired by the European Medicines Agency (EMA) with co-chairs from ANVISA Brazil and PMDA Japan.

The anniversary will be celebrated during ICMRA's annual Summit and Plenary in Melbourne on 13-16 November, hosted by the Therapeutic Goods Administration (TGA) of Australia. ICMRA members will exchange views and discuss topics such as the use of artificial intelligence and machine learning in medicine regulation, evolution of clinical trials and advanced medical products based on genes, cells or tissue engineering.

In the past decade, ICMRA has made significant progress in a range of areas which are at the heart of the work of many regulators worldwide. Significant milestones include activities supporting the fight against antimicrobial resistance and the management of medicines shortages, but also topics such as clinical trials, pharmacovigilance, regulatory convergence and reliance, innovation, real-world evidence and alignment in the global COVID-19 response.

"It is important to act both locally and globally to address shared regulatory issues and challenges. Through ICMRA, we work as a global community to safeguard public health by providing strategic leadership, advancing regulatory science, sharing information and responding to crises", said Emer Cooke, EMA's Executive Director and chair of ICMRA.

ICMRA's major achievement is the leadership provided by its members working together during the COVID-19 pandemic. The Coalition worked to expedite and streamline development and approval of COVID-19 vaccines and treatments and helped to increase the efficiency and effectiveness of regulatory processes and decision making. ICMRA called for large, well-designed clinical trials to ensure regulators have solid evidence for decision making and organised workshops on manufacturing, safety and efficacy of COVID-19 vaccines.

"During the pandemic, we managed to coordinate our response. When we discuss global health, we aim for global solutions. If it is not a solution for all, it is not a solution at all", said Antorio Torres, Executive Director of ANVISA and co-chair of ICMRA.

In June 2023, ICMRA received the Global Award for Outstanding Contribution to Health at the Drug Information Associations (DIA) Global Annual Meeting.

In the coming years, ICMRA will continue to address current and emerging human medicine regulatory and safety challenges, strengthen collaboration and communication and enhance the quality, safety and efficacy of medicines for the benefit of patients worldwide.


  1. More information on the anniversary, including a video and an infographic on key milestones, are available on the ICMRA website
  2. Website of the ICMRA Summit 2023.

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