Logo of the International Coalition of Medicines Regulatory Authorities

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.

ICMRA marks its 10th anniversary at the ICMRA summit on 13-16 November 2023 in Melbourne, Australia.

Membership

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: 

EMA role

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 ongoinginternational collaborative regulatory initiatives to help the coalition to make informed decisions on the need for involvement or strategic coordination.

This project aimed to:

  • help the coalition make informed decisions on the need for involvement or strategic coordination;
  • raise awareness of ongoing international activities in the area of human medicines regulation;
  • provide the first comprehensive overview of international projects that medicines regulators are involved in.

The findings are available in this report, published in October 2016:

These sector-specific mapping documents set 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.

Cooperation to support the development of COVID-19 medicines

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.

Pledges and recommendations

ReportReport from the ICMRA/WHO workshop on: Global perspectives on COVID-19 vaccines strain update
DatePublished: 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:

  • provides an overview of key regulatory considerations related to updated COVID-19 vaccine composition;
  • highlights data requirements for authorised vaccines to support the approval of strain changes;
  • details plans by international regulators and World Health Organization (WHO) to put in place a structured process to support and optimise COVID-19 vaccine antigen recommendations.

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.

 StatementStatement 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:

  • clinical data, including effectiveness studies;
  • spread and monitoring of COVID-19 virus variants;
  • commonly reported adverse drug reactions for each vaccine type;
  • the use of vaccine boosters and vaccine safety in children and pregnant women.

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 announcementInternational regulators’ reflections on remote approaches to GCP and GMP regulatory oversight during COVID-19 pandemic
Reflection paperReflections on the regulatory experience of remote approaches to
GCP and GMP regulatory oversight during the COVID-19 Pandemic
Date13/12/2021
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 announcementInternational regulators stress continued need for COVID-19 therapeutics
Statement Statement on need for continued focus on COVID-19 therapeutics
Date10/12/2021
Summary

This statement signals the ongoing need for safe, effective and accessible COVID-19 treatments to complement vaccination.

This is especially important: 

  • for treatment options for people unable to get vaccinated or with lower immune response to vaccines
  • to address break-through infections
  • to tackle the emergence of SARS-CoV-2 variants with some level of vaccine resistance
  • to address waning immunity

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 announcementICMRA 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
Date03/12/2021
Summary

The report features concrete examples of regulatory flexibilities and extraordinary measures put in place in different areas of medicines regulation, including:
•    clinical trial oversight; 
•    registration and marketing authorisation; 
•    good manufacturing practice (GMP), good clinical practice (GCP) and good distribution practice (GDP)
•    post-authorisation activities and pharmacovigilance;
•    facilitating access and managing medicine shortages;
•    medical devices, including personal protective equipment (PPE) and sanitisers.
It encourages regulators to share experience on the effectiveness of regulatory flexibilities applied during the pandemic.

News announcementA 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
Date12/10/2021
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:
•    have good knowledge of products and processes;
•    comply with good manufacturing practice (GMP);
•    establish effective pharmaceutical quality systems.
These will enable regulatory authorities to facilitate changes to medicines after authorisation flexibly. In turn, this will allow companies to expand their manufacturing capacity for the treatments and vaccines that are needed across the world during pandemics such as COVID-19. 

Statement

Statement on the importance of continuing COVID-19 vaccine trials following regulatory approval

Date27/11/2020
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.

StatementJoint ICMRA / World Health Organization (WHO) joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines
Date06/11/2020
Summary

ICMRA and WHO have committed to work together, in order to ensure that:

  • patients have access to safe and effective medicines against COVID-19 as early as possible;
  • rigorous scientific standards for the evaluation and safety monitoring of treatments and vaccines are maintained at all times.

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.

StatementICMRA statement on clinical trials
Date01/07/2020
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.

StatementICMRA statement on COVID-19: International regulators pledge collective support to combat COVID-19
Date20/04/2020
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:

  • 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.

StatementICMRA statement on the safety of COVID-19 vaccines
Date05/07/2023
Summary

This statement focuses on the safety of COVID vaccines and common types of misinformation.

It emphasises:

  • benefits of COVID-19 vaccination, such as significantly reducing the risk of severe disease, hospitalisation and death;
  • evidence of long-term COVID-19 vaccine safety based on over two years of safety data, including in children and special populations;
  • emerging evidence on the effectiveness of COVID-19 vaccines against symptoms of long COVID.

Strategic meetings and regulatory workshops

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:

  • pragmatic approaches to the COVID-19 response;
  • regulatory flexibility in the context of the medical emergency;
  • extraordinary measures applied to address common challenges during the pandemic;
  • regulatory considerations related to COVID-19 clinical trial management;
  • prevention and mitigation of supply issues.

EMA and the United States Food and Drug Administration (FDA) chair alternate meetings.

International regulators and experts from WHO and the European Commission discussed regulatory challenges including:

  • the COVID-19 pandemic and the global response to the Omicron variant
  • antimicrobial resistance
  • medicines for use in pregnancy
  • supply chain integrity

EMA and the Brazilian National Health Surveillance Agency (ANVISA) co-chaired the meeting.

DATEMORE 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:

  • the latest evidence on the Omicron variant, including on the effectiveness of approved COVID-19 vaccines against the Omicron variant and real-world data on the effectiveness of boosters;
  • clinical-study design for vaccines adapted to the Omicron variant and the optimal composition of future COVID-19 vaccines.

EMA co-chaired the meeting together with the US Food and Drug Administration (FDA).

DATEMORE INFORMATION
12/01/2022

During these workshops, international regulators discussed issues relating to emerging COVID-19 virus variants. These included:

  • Impact of virus variants on the efficacy of COVID-19 vaccines and therapeutics
  • Options for regulators in responding to the spread of virus variants
  • Key principles on adapting COVID-19 vaccines, designed to provide improved protection against virus variants.
DATEMORE INFORMATION
30/06/2022
12/01/2022
24/06/2021
10/02/2021

Regulators and industry stakeholders discussed regulatory approaches to enable:

  • rapid increases in manufacturing capacity for COVID-19 treatments and vaccines;
  • a more efficient and effective response to the COVID-19 global public health emergency.
DATEMORE 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:

  • knowledge gaps and how to overcome them;
  • differences in regulatory requirements, with the aim of working towards convergence;
  • opportunities for further international collaboration.

EMA, U.S. Food and Drug Administration and Medicines and Healthcare products Regulatory Agency co-chaired the workshop.

These workshops allow international regulators to discuss priority areas for cooperation on COVID-19-related observational research, including:

  • research on the impact of COVID-19 and resulting medication use on pregnant women and their unborn babies;
  • use of international clinical cohorts of COVID-19 patients and criteria for the selection of research topics;
  • development of infrastructure for monitoring the safety and effectiveness of COVID-19 vaccines.

EMA and Health Canada co-chair the workshops.

DATEMORE 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:

  • non-clinical and clinical data required to progress to subsequent clinical-trial stages;
  • eligibility criteria for inclusion of diverse populations, primary endpoints and other methodological considerations related to the design of phase 3 clinical trials;
  • the need to address the theoretical risk that vaccines against COVID-19 might enhance the disease prior to starting first-in-human clinical trials;
  • the balance between rapid development of vaccines and the need to generate enough robust data to enable decision-making.

EMA and the United States Food and Drug Administration (FDA) co-chair the workshops.

These workshops allow international regulators to discuss key issues around the development of COVID-19 treatments, such as:

  • progress made in the development of COVID-19 treatments;
  • availability of potential COVID-19 treatments
  • ongoing and planned clinical trials;
  • acceptable clinical-trial endpoints to facilitate rapid and consistent clinical trials for COVID-19 treatments;
  • need for large clinical trials to generate conclusive evidence on which treatments work;
  • compassionate use and off-label use of medicines in the context of COVID-19 .

EMA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) co-chair the workshops.

During this workshop, ICMRA discussed the key developments on adapted vaccines and options to change their composition in the future. Topics included: 

  • Use of data to support updates to adapted vaccines;
  • Preferable vaccine composition based on COVID-19 lessons learned and emerging evidence; 
  • Considerations for simplifying the product information.

EMA co-chaired the meeting together with the US Food and Drug administration (FDA). 

 

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)

Cooperation on other topics

Global regulators cooperate under the umbrella of ICMRA in a range of areas related to the regulation of human medicines that are common to many of the participating regulatory authorities’ missions. More information on these cooperation initiatives is available under 'Strategic initiatives' and 'News' on ICMRA's website.

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:

  • Development of a global Pharmaceutical Quality Knowledge Management System
  • Collaborative assessments of post-approval changes
  • Hybrid inspections
DATEMORE INFORMATION
20/07/2023

 

News announcementBest practices to fight antimicrobial resistance
ICMRA report

Antimicrobial Resistance Best Practices

(Also available in French)

Date21/11/2022
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:

  • regulatory flexibilities for novel therapies; 
  • lessons learned from the COVID-19 pandemic;
  • treatment recommendations;
  • monitoring methods.

ICMRA recognises AMR as a complex, multifaceted problem that requires better coordination across all sectors, including public health, animal health and the environment.

StatementInternational collaboration to enable real-world evidence (RWE) for regulatory decision-making
News announcementGlobal regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
Date22/07/2022
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:

  • Harmonisation of terminologies for real-world data and real-world evidence
  • Regulatory convergence on real-world data and real-world evidence guidance and best practice
  • Readiness to address public health challenges and emerging health threats
  • Transparency

This statement is the outcome of the workshop described below.

Date of workshop29-30/06/2022
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: 

  • overview of RWE terminology;
  • real-world data (RWD) and RWE use cases and their value;
  • analysis of international initiatives;
  • data sources and metadata used to generate RWE;
  • opportunities brought by the worldwide use of federated data networks, and its challenges.

EMA co-chaired the workshop together with the United States' Food and Drug Administration and Health Canada.

News announcementArtificial intelligence in medicine regulation
ICMRA reportICMRA Informal Innovation Network - Horizon Scanning Assessment Report - Artificial Intelligence
Date16/08/2021
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 announcementInteroperability of track and trace systems: key to public health protection
ICMRA paperRecommendations on common technical denominators for traceability systems for medicines to allow for interoperability
Date of publication06/08/2021
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 
Date11/06/2021
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 

Joint Statement on transparency and data integrity

Date07/05/2021
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:

  • increase trust in regulatory decision-making;
  • reassure the public about data integrity;
  • stimulate research and development.

StatementStatement on the value of regulatory reliance
Date27/11/2020
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)

Date18/06/2020
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)

Date31/07/2019
Summary

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.

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