International Coalition of Medicines Regulatory Authorities (ICMRA)
The European Medicines Agency (EMA) is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA is a voluntary, executive-level entity of worldwide medicines regulatory authorities set up to provide strategic coordination, advocacy and leadership.
ICMRA acts as a forum to support international cooperation among medicines regulatory authorities. The coalition aims to:
- identify ways to better use existing initiatives and resources;
- develop strategies to address current and emerging challenges in global human medicine regulation, such as the growing complexity of globalised supply chains;
- provide direction for common activities and areas of work.
To achieve these aims, ICMRA supports enhanced communication, information sharing and a greater leveraging of resources.
Membership of ICMRA is voluntary and is open to all medicines regulatory authorities. It includes EMA, the European Commission and a number of European national competent authorities and global medicines regulatory authorities.
For a full list of participating authorities, see ICMRA: Participating regulatory authorities.
ICMRA members meet at least once a year in person.
As of 1 October 2019, EMA’s Executive Director Guido Rasi is the chair of ICMRA.
EMA has led the ICMRA project of mapping ongoing international collaborative regulatory initiatives to help the coalition to make informed decisions on the need for involvement or strategic coordination.
The project also aims at raising awareness of ongoing international activities in the area of human medicines regulation and provides for the first time a comprehensive overview of international projects in which medicines regulators are involved.
EMA published a report in October 2016, describing activities between February 2014 to December 2015. This report includes a summary of the different mapping exercises performed, the steps taken to analyse them and how the outcomes informed ICMRA's strategic priorities.
- Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives
EMA also published a set of sector-specific mapping documents in December 2016. These set out the international initiatives in different areas of medicines regulation:
- ICMRA - Mapping of IT initiatives as a support to global medicines regulation
- ICMRA - Mapping of crisis management initiatives
- ICMRA - Mapping of generic initiatives
- ICMRA - Mapping of GMP inspection initiatives
- ICMRA - Mapping of multinational project initiatives
- ICMRA - Mapping of pharmacovigilance initiatives
- ICMRA - Mapping of supply chain anticounterfeiting initiatives
- ICMRA - Mapping of the bilateral arrangements between the ICMRA members
The sector-specific mapping documents are 'living documents' and may be amended to reflect new initiatives or changes to existing ones.
Stakeholders can send suggestions on the published mappings to firstname.lastname@example.org. EMA will take these into consideration for future revision.
Medicine regulatory authorities worldwide are cooperating under the umbrella of ICMRA with the aim of expediting and streamlining the development and approval of COVID-19 vaccines and treatments worldwide. ICMRA members also work towards increasing the efficiency and effectiveness of regulatory processes and decision-making.
Pledges and recommendations
In April 2020, ICMRA members pledged to strengthen global collaborative efforts to align the facilitation of rapid development, approval and global roll-out of safe and effective medicines and vaccines to prevent and treat COVID-19:
- ICMRA statement on COVID-19: International regulators pledge collective support to combat COVID-19 (20/04/2020)
ICMRA members recommend that:
- governments and the international research community prioritise large, well-designed, controlled clinical trials. Such trials are most likely to generate the conclusive evidence that developers and regulators need to enable the rapid development and approval of potential COVID-19 treatments;
- a global approach be developed to achieve equitable access around the world to treatments and vaccines against COVID-19;
- the pharmaceutical industry work cooperatively in addressing medicine supply issues, shortages and decreased manufacturing capacities.
In June 2020, ICMRA members outlined the key characteristics of clinical trials that are most likely to generate conclusive evidence to enable the accelerated approval of medicines for COVID-19:
- ICMRA statement on clinical trials (01/07/2020)
ICMRA members also specified concrete actions that COVID-19 clinical-trial investigators should take when collecting, analysing and reporting data.
ICMRA encourages investigators to make the results of their trials publicly available.
Strategic meetings and regulatory workshops
ICMRA members discuss international alignment on COVID-19 policies in strategic meetings held every two weeks.
ICMRA is also holding international regulatory workshops on important topics to allow for in-depth discussions between medicine regulatory authorities and delegates from many countries worldwide, as well as with experts from the World Health Organization and the European Commission.
Click on the meeting types below to find out more, including summary reports and related news.
ICMRA issued statements on vaccine confidence for the general public and on vaccine safety and effectiveness for healthcare professionals:
- ICMRA statements on vaccine confidence and vaccine safety and effectiveness (18/06/2020) (available in 7 languages)
The statements explain the robust scientific and independent processes that medicines regulators worldwide follow. These ensure that only vaccines that conform to the highest standards of safety and effectiveness can reach and remain on the market.
The statements emphasise the fact that it is everyone's responsibility to get vaccinated to protect themselves, as well as their families, friends and communities. It also helps to protect vulnerable people who cannot get vaccinated.
ICMRA members produced these statements to highlight the benefits and safety of vaccines, and their importance in preventing and controlling infectious diseases.
For more information on vaccines and vaccination in the EU, see the European Vaccination Information Portal.
To mark World Antibiotic Awareness Week in 2019, EMA highlighted ICMRA's statement committing its support to the fight against antimicrobial resistance:
The statement emphasises the:
- need for cross-sectoral, global cooperation to fight the spread of antimicrobial resistance;
- role of medicines regulators in efficiently bringing to the market safe, effective and high-quality products that can help combat antimicrobial resistance, as well as ensuring that no undue regulatory barriers prevent access to critical antimicrobials;
- responsibilities of various stakeholders to increase investment in research and development, incentivise innovation, improve prescribing principles for antibiotics and ensure adequate media coverage to maintain public awareness.