The coalition aims to:
To achieve these aims, ICMRA supports enhanced communication, information sharing and a greater leveraging of resources.
ICMRA marks its 10th anniversary at the ICMRA summit on 13-16 November 2023 in Melbourne, Australia.
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 the latest list of authorities participating in ICMRA, see:
The EMA Executive Director has been the chair of ICMRA since 1 October 2019.
Ms Emer Cooke, who took over leadership of ICMRA in November 2020, was elected in 2022 to serve a three-year term as chair until 30 September 2025.
EMA led ICMRA's project to map ongoing international collaborative regulatory initiatives to help the coalition to make informed decisions on the need for involvement or strategic coordination.
This project aimed to:
The findings are available in this report, published in October 2016:
Select the expandable panel below (via the downward arrow) to access sector-specific mapping documents setting out the international initiatives in various areas of medicines regulation:
These documents were published in December 2016, but may be amended to reflect new initiatives or changes to existing ones.
Stakeholders can send suggestions on the published mappings to emainternational@ema.europa.eu. EMA will take these into consideration for future revision.
Medicine regulatory authorities worldwide are working together under the umbrella of ICMRA with the aim of expediting and streamlining the development and approval of COVID-19 medicines, both vaccines and treatments. ICMRA members are also working towards increasing the efficiency and effectiveness of regulatory processes and decision-making.
| Report | Report from the ICMRA/WHO workshop on: Global perspectives on COVID-19 vaccines strain update |
| Date | Published: 17 April 2024 |
| Summary | International regulators agreed on timing and data requirements for the COVID-19 vaccine strain updates. They have published a report that:
This report, published in April 2024, follows a workshop on COVID-19 vaccine strain updates that was organised by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the WHO. |
| Statement | Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness |
| Date | Updated: 17/05/2022 First published: 19/01/2021 |
| Summary | This statement intends to help healthcare professionals increase trust and confidence in COVID-19 vaccines among patients and answer their questions. It covers the development, the regulatory review and the safety-monitoring of COVID-19 vaccines, emphasising the extensive scientific evaluations that determine their safety, efficacy and quality. The statement provides information on:
ICMRA developed the latest version of this statement jointly with the World Health Organization (WHO). This update, published in May 2022, followed a series of discussions between ICMRA members and the WHO on the importance of public confidence in COVID-19 vaccines. |
| News announcement | International regulators’ reflections on remote approaches to GCP and GMP regulatory oversight during COVID-19 pandemic |
| Reflection paper | Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 Pandemic |
| Date | 13/12/2021 |
| Summary | This reflection paper reviews regulators’ experiences of overseeing good clinical practice (GCP) and good manufacturing practice (GMP) during the COVID-19 pandemic. The regulatory authorities reported that they had been using video conferencing and other digital technologies to carry out remote GCP and GMP inspections, evaluations and assessments. Although its review found that several key inspection techniques could not be replicated using remote-working tools, ICMRA did find them to be useful in complementing on-site inspections during the pandemic. |
| News announcement | International regulators stress continued need for COVID-19 therapeutics |
| Statement | Statement on need for continued focus on COVID-19 therapeutics |
| Date | 10/12/2021 |
| Summary | This statement signals the ongoing need for safe, effective and accessible COVID-19 treatments to complement vaccination. This is especially important:
ICMRA calls on researchers, industry, healthcare professionals, health research funding agencies, research institutions, and others to focus development efforts on therapeutics addressing the full spectrum of the COVID-19 disease in all populations - including those who are underrepresented or underserved, and those living in low- and middle-income countries. |
| News announcement | ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic |
| Report | Report on the review of regulatory flexibilities/ agilities implemented by national regulatory authorities during the COVID-19 pandemic |
| Date | 03/12/2021 |
| Summary | The report features concrete examples of regulatory flexibilities and extraordinary measures put in place in different areas of medicines regulation, including: |
| News announcement | A global approach to regulatory flexibility to increase manufacturing capacity during COVID-19 |
| Statement | Statement on pre-requisites for regulatory flexibility in pharmaceutical manufacturing change management |
| Date | 12/10/2021 |
| Summary | This statement encourages pharmaceutical companies and manufacturers to demonstrate their ongoing commitment to quality. It urges them to do this by making sure they: |
| Statement | Statement on the importance of continuing COVID-19 vaccine trials following regulatory approval |
| Date | 27/11/2020 |
| Summary | ICMRA members encouraged stakeholders responsible for clinical trials of COVID-19 vaccines to continue running these trials for as long as is feasible. This will allow the trials to go on collecting critical data in support of further regulatory actions and vaccine deployment, and allow investigators to gather data about vaccine safety and efficacy after they have completed the analyses required for regulatory purposes. Continued follow-up of trial participants may also provide important information on the vaccines’ longer-term safety and efficacy. This could include their efficacy against severe disease or in different subgroups, and whether or not protection wanes over time. |
| Statement | Joint ICMRA / World Health Organization (WHO) joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines |
| Date | 06/11/2020 |
| Summary | ICMRA and WHO have committed to work together, in order to ensure that:
ICMRA and WHO also pledged to take concrete actions to ensure equitable access to safe, effective and quality-assured medicines for the treatment or prevention of COVID-19 around the world. |
| Statement | ICMRA statement on clinical trials |
| Date | 01/07/2020 |
| Summary | 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. They also specified concrete actions that COVID-19 clinical-trial investigators should take when collecting, analysing and reporting data. ICMRA is encouraging investigators to make the results of their trials publicly available. |
| Statement | ICMRA statement on COVID-19: International regulators pledge collective support to combat COVID-19 |
| Date | 20/04/2020 |
| Summary | 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. They recommended that:
|
| Statement | ICMRA statement on the safety of COVID-19 vaccines |
| Date | 05/07/2023 |
| Summary | This statement focuses on the safety of COVID vaccines and common types of misinformation. It emphasises:
|
ICMRA members discuss international alignmenton COVID-19 policies in strategic meetings.
ICMRA is also holding international regulatory workshops on important COVID-19-related topics to allow for in-depth discussions between medicine regulatory authorities and delegates from 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 members discuss international alignment on COVID-19 policies in strategic meetings being held every two weeks. These focus on:
EMA and the United States Food and Drug Administration (FDA) chair alternate meetings.
| DATE | CHAIR | MORE INFORMATION |
|---|---|---|
| 06/08/2020 | FDA | - |
| 23/07/2020 | EMA | - |
| 09/07/2020 | FDA | - |
| 26/05/2020 | EMA | - |
| 12/06/2020 | FDA | Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4 (15/06/2020) |
| 27/05/2020 | EMA | Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3 (28/05/2020) |
| 14/05/2020 | FDA | Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2 (28/05/2020) |
| 30/04/2020 | EMA | Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 (05/05/2020) |
| 16/04/2020 | FDA | ICMRA aims for international alignment on policy approaches and regulatory flexibility during COVID-19 pandemic (21/04/2020) |
International regulators and experts from WHO and the European Commission discussed regulatory challenges including:
EMA and the Brazilian National Health Surveillance Agency (ANVISA) co-chaired the meeting.
| DATE | MORE INFORMATION |
|---|---|
| 01-02/12/2021 |
The goal of this meeting was to align regulatory requirements to support the potential development of an adapted vaccine.
At this workshop, ICMRA discussed:
EMA co-chaired the meeting together with the US Food and Drug Administration (FDA).
During these workshops, international regulators discussed issues relating to emerging COVID-19 virus variants. These included:
| DATE | MORE INFORMATION |
|---|---|
| 30/06/2022 | |
| 12/01/2022 |
|
| 24/06/2021 | |
| 10/02/2021 |
Regulators and industry stakeholders discussed regulatory approaches to enable:
| DATE | MORE INFORMATION |
|---|---|
| 07-08/07/2021 |
During the workshop, international regulators discussed issues around COVID-19 vaccines and therapies in pregnant and breastfeeding women, such as:
EMA, U.S. Food and Drug Administration and Medicines and Healthcare products Regulatory Agency co-chaired the workshop.
| DATE | MORE INFORMATION |
|---|---|
| 09/02/2021 |
These workshops allow international regulators to discuss priority areas for cooperation on COVID-19-related observational research, including:
EMA and Health Canada co-chair the workshops.
| DATE | MORE INFORMATION |
|---|---|
| 20/05/2022 | |
| 10/05/2021 | |
| 25/01/2021 | |
| 13/10/2020 | |
| 22/07/2020 | |
| 19/05/2020 | |
| 06/04/2020 |
These workshops allow international regulators to discuss key issues around the development of COVID-19 vaccines, such as:
EMA and the United States Food and Drug Administration (FDA) co-chair the workshops.
| DATE | MORE INFORMATION |
|---|---|
| 22/05/2020 | |
| 18/03/2020 |
These workshops allow international regulators to discuss key issues around the development of COVID-19 treatments, such as:
EMA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) co-chair the workshops.
| DATE | MORE INFORMATION |
|---|---|
| 20/07/2020 | |
| 02/04/2020 |
During this workshop, ICMRA discussed the key developments on adapted vaccines and options to change their composition in the future. Topics included:
EMA co-chaired the meeting together with the US Food and Drug administration (FDA).
| DATE | MORE INFORMATION |
|---|---|
| 08/05/2023 |
Information on global cooperation on COVID-19 under the umbrella of ICMRA is also available on ICMRA's website
For more information on how EMA is handling the COVID-19 pandemic, see Coronavirus disease (COVID-19)
Global regulators cooperate under the umbrella of ICMRA in a range of areas related to the regulation of human medicines.
These areas include antimicrobial resistance, real-world evidence, transparency and data integrity.
They are common to many of the participating regulatory authorities’ missions.
More information is available under 'Strategic initiatives' and 'News' on ICMRA's website.
| Statement | Global regulators commit to playing their part in tackling antimicrobial resistance as a priority |
| Date | 21/11/2024 |
| Summary | ICMRA members reiterate that preserving the effectiveness of antimicrobials is a top priority. They stress that regulators have an important role to play in addressing the global public health challenge of antimicrobial resistance. They also agree on the need for a multifaceted approach to tackling antimicrobial resistance that includes:
|
| News announcement | Best practices to fight antimicrobial resistance |
| ICMRA report | Antimicrobial Resistance Best Practices (Also available in French) |
| Date | 21/11/2022 |
| Summary | In support of World Antimicrobial Awareness Week 2022, ICMRA published a report that highlights successful regulatory and non-regulatory interventions. These are used in different countries to address the growing public health threat of antimicrobial resistance (AMR). The ICMRA report includes a number of case studies on best practices to address AMR and antimicrobial use. They include:
ICMRA recognises AMR as a complex, multifaceted problem that requires better coordination across all sectors, including public health, animal health and the environment. |
| Statement | International collaboration to enable real-world evidence (RWE) for regulatory decision-making |
| News announcement | Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making |
| Date | 22/07/2022 |
| Summary | In this statement, ICMRA members pledge to foster global efforts and further enable the integration of real-world evidence into regulatory decision-making. They identify the following four focus areas for regulatory cooperation:
This statement is the outcome of the workshop described below. |
| Date of workshop | 29-30/06/2022 |
| Workshop summary | This workshop allowed regulators to share their accomplishments and challenges in generating real-world evidence (RWE) to support the assessment of medicines. It also aimed to identify opportunities for regulatory collaboration. Topics included:
EMA co-chaired the workshop together with the United States' Food and Drug Administration and Health Canada. |
| News announcement | Artificial intelligence in medicine regulation |
| ICMRA report | ICMRA Informal Innovation Network - Horizon Scanning Assessment Report - Artificial Intelligence |
| Date | 16/08/2021 |
| Summary | This ICMRA report contains recommendations to help regulators address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation. It identifies key issues linked to the regulation of future therapies using AI, based on a horizon-scanning exercise carried out by ICMRA's Informal Network for Innovation working group and led by EMA. |
| News announcement | Interoperability of track and trace systems: key to public health protection |
| ICMRA paper | Recommendations on common technical denominators for traceability systems for medicines to allow for interoperability |
| Date of publication | 06/08/2021 |
| Summary | ICMRA has finalised a paper with recommendations to facilitate the use of track and trace systems at the global level. It identifies common technical denominators that allow different systems to exchange information on medicines and their supply chains to protect public health. International regulators emphasise that the interoperability of track and trace systems helps protect public health by improving information sharing in case of quality defects, reducing shortages, contributing to the fight against falsified medicines and supporting pharmacovigilance activities. ICMRA developed the recommendations in consultation with the World Health Organisation (WHO), representatives from international medicines regulatory authorities and experts from the private sector. It was available for public consultation from November 2020 to February 2021. |
| Statement | |
| Date | 11/06/2021 |
| Summary | ICMRA members outlined the objectives and benefits of building a collective capability between regulators for pharmaceutical quality knowledge management. These include enhanced information-sharing and regulatory reliance between regulators, and harmonised data expectations for sponsors. This is expected to speed up patient access to medicines, by shortening approval timelines. The statement also describes the multi-stakeholder approach ICMRA members recommend for building this capability, with regulators, legislators, and industry innovators working together collaboratively and transparently. |
| Statement | |
| Date | 07/05/2021 |
| Summary | ICMRA and WHO urged pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions, to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In their statement, they stressed that systematic transparency can:
|
| Statement | Statement on the value of regulatory reliance |
| Date | 27/11/2020 |
| Summary | ICMRA members expressed their support for regulatory reliance. Regulatory reliance is when a national authority takes the assessments of another authority, a trusted institution or an authoritative information source into account and gives them significant weight, when reaching its own decisions. ICMRA emphasised how regulatory reliance can help streamline responses and facilitate efforts during public health emergencies, such as the COVID-19 pandemic, which has shown the importance of regulatory cooperation and information sharing. ICMRA invited national authorities to use regulatory reliance to support the efficient allocation of resources and to improve access to medicines |
| Statement | ICMRA statement for patients and healthcare professionals on vaccine confidence and vaccine safety and effectiveness (available in 7 languages) |
| Date | 18/06/2020 |
| Summary | 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.
| Statement | ICMRA statement from global medicines regulators on combatting antimicrobial resistance (Also available in French, Spanish and Portuguese) |
| Date | 31/07/2019 |
| Summary | The statement emphasises the:
|
The purpose of this workshop was to look at the status of mpox vaccines and antivirals.
International regulators also discussed current approval processes, coordinated future research efforts and looked at additional evidence required to facilitate rapid regulatory decisions.
EMA co-chaired the workshop together with the National Agency for Food and Drug Administration and Control (NAFDAC).
This workshop discussed progress in the development of a global Pharmaceutical Quality Knowledge Management System, and efforts by regulators to help reduce the need for multiple submissions from companies, avoid duplicative assessments by regulators and facilitate inspection reliance to build stronger global resilience. Topics included the following:
| DATE | MORE INFORMATION |
|---|---|
| 20/07/2023 |
