COVID-19

During the ongoing COVID-19 pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) is acting as a forum to support strategic coordination and international cooperation among global medicine regulatory authorities.

The aim of these activities is to expedite and streamline the development, authorisation and availability of COVID-19 treatments and vaccines worldwide. ICMRA members also work towards increasing the efficiency and effectiveness of regulatory processes and decision-making.

 

Collective support to combat COVID-19

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 to prevent and treat COVID-19.

ICMRA statement on COVID-19: International regulators pledge collective support to combat COVID-19 (28 April 2020)

In their joint statement ICMRA members recommend that:

  • governments and the international research community should 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 should be developed to achieve equitable access around the world to treatments and vaccines against COVID-19;
  • pharmaceutical industry should work cooperatively in addressing medicine supply issues, shortages and decreased manufacturing capacities.

 

In June 2020, ICMRA members committed to stepping up the global collaboration and prioritisation of COVID-19 clinical trials, with the aim of expediting COVID-19 medicine and vaccine development and approval based on robust scientific evidence.

ICMRA statement on clinical trials: International regulators provide guidance on prioritisation of COVID-19 clinical trials (24 June 2020)

In the joint statement on clinical trials, ICMRA members:

  • describe the key characteristics of clinical trials that are most likely to generate the conclusive evidence needed to enable the accelerated approval of potential treatments and vaccines against COVID-19;
  • set out concrete actions that stakeholders involved with COVID-19 clinical trials should take to collect, analyse and report the data required to determine which investigational or repurposed medicinal products would be safe and effective for the treatment or prevention of COVID-19;
  • emphasise their commitment to cooperate, expedite and share the evaluation of all COVID-19 trial results submitted to them;
  • pledge to provide clear and transparent benefit-risk analyses in order to support the approval of effective and safe medicines, biologics, and vaccines against COVID-19.

 

In November, ICMRA and the World Health Organization (WHO) committed to working together to ensure that patients have access to safe and effective medicines against COVID-19 as early as possible, while the existing rigorous scientific standards for the evaluation and safety monitoring of treatments and vaccines are maintained at all times.

WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines (6 November 2020)

In their joint statement, ICMRA members and WHO:

  • reiterate that therapeutics and vaccines against COVID-19 can only be rapidly approved if applications are supported by robust and sound scientific evidence that allows medicine regulators to conclude on a positive benefit-risk balance for these products;
  • pledge 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 in other languages

 

ICMRA urges all stakeholders, including vaccines researchers and investigators, academia, regulators and the pharmaceutical industry to continue COVID-19 vaccine trials beyond the time when the pre-defined cases of COVID-19 disease for final analysis in a trial have been reached. This can provide important additional and more precise information on longer-term safety and efficacy of a vaccine against COVID-19.

ICMRA statement on continuation of vaccine trials (27 November 2020)

Statement in other languages

 

Promoting confidence in COVID-19 vaccines

ICMRA members from around the world have jointly developed a statement to inform and help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines. It explains how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety will continue to be closely monitored after approval.

ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness (19 January 2021)

Statement in other languages

 

The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have jointly developed a statement to help healthcare professionals increase trust and confidence in COVID-19 vaccines and answer questions from patients about the development, regulatory review and safety monitoring of these vaccines.

Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021)
Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization
 [PDF]

Statement in other languages

 

The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have jointly developed a statement aimed to help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines and to reassure medical staff about the safety of COVID-19 vaccines that undergo a robust scientific evaluation to determine their quality, safety and efficacy. The statement outlines measures put in place nationally and globally to continuously monitor the safety of COVID-19 vaccines that are used in countries worldwide. It also contains up-to-date information on clinical trial data (including effectiveness studies), COVID-19 virus variants, commonly reported adverse events for each vaccine type as well as the latest advice on vaccine boosters and vaccine safety in children and pregnant women.

The development of the latest version of this statement, which was last updated in 2021, followed a series of discussions among ICMRA members and WHO on the importance of public confidence in COVID-19 vaccines.

Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022)
Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization
[PDF]

Statement in other languages

 

ICMRA and the World Health Organization (WHO) are urging 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 health care decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity and can stimulate research and development, which could have a positive impact on vaccine confidence.

Joint Statement on transparency and data integrity (7 May 2021) [PDF]

Statement in other languages

 

ICMRA and the World Health Organization (WHO) have reviewed some of the practices applied by regulatory authorities worldwide to respond to the challenges faced during the COVID-19 pandemic. Their report features concrete examples of regulatory flexibilities and extraordinary measures put in place in different areas of medicines regulation, including, among others, clinical trial oversight, marketing authorisation, inspections and pharmacovigilance.

Report on regulatory flexibilities implemented by national regulatory authorities during the pandemic (3 December 2021)

 

ICMRA and the World Health Organization (WHO) have reviewed provisions and procedures for emergency authorisation of COVID-19 medicines used during the pandemic. Their key findings, including similarities, unique features, enablers and limitations associated with emergency use procedures, are summarised in a report published in December 2021.

Emergency Use Approval deep dive report on the review of provisions and procedures for emergency authorisation of medical products for COVID-19 among ICMRA members (10 December 2021)

 

ICMRA urges all stakeholders, including researchers, pharmaceutical industry, healthcare professionals, health research funding agencies and research institutions, to continue their focus on developing therapeutics to treat and prevent COVID-19 in patients around the world. In a joint statement, ICMRA members highlight the continued need for safe, effective and high-quality COVID-19 treatments for all populations, including those who are underrepresented or underserved, and those living in low- and middle-income countries.

ICMRA statement on need for continued focus on COVID-19 therapeutics (10 December 2021)

Statement in other languages

 

ICMRA has published a reflection paper on some of the practices applied by international regulatory authorities during the COVID-19 pandemic to enable remote oversight of good clinical practice (GCP) and good manufacturing practice (GMP) activities. The purpose of this paper is to provide transparency to stakeholders on approaches taken to date during the pandemic.

Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 pandemic (10 December 2021)

 

 

COVID-19 meetings and workshops

ICMRA members discuss international alignment on COVID-19 policies in strategic meetings held every two weeks. These also focus on:

  • pragmatic approaches to 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/mitigation of supply issues.

ICMRA is also holding international regulatory workshops on important topics to allow for in-depth discussions and to agree on common approaches. In addition to delegates representing 28 medicines regulatory authorities globally, participants include experts from the World Health Organization and the European Commission.

 

Calendar of meetings and workshops

 

Date Event More information
19 April 2022 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
24 February 2022 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
20 January 2022 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
12 January 2022 ICMRA COVID-19 Omicron variant workshop Meeting report
16 December 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
18 November 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19

28 October 2021

Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
23 September 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
26 August 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
22 July 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
7-8 July 2021 ICMRA workshop on enabling manufacturing capacity in the COVID-19 pandemic

Workshop Report
Presentation
Transcript
Video recording

ICMRA Statement on Pre-Requisites for Regulatory Flexibility in Pharmaceutical Manufacturing Change Management

24 June 2021 ICMRA COVID-19 Virus Variants Workshop Meeting report
Presentation - Summary outcomes of WHO Global Consultation
Presentation - WHO updates on correlates of protection
Presentation - Trial designs for new SARS-CoV2 vaccines
Presentation - Collaboration in clinical trials
Presentation - Demonstration of effectiveness of second-generation COVID-19 vaccines
10 June 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
20 May 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
10 May 2021 International regulatory workshop on observational studies and real-world data ICMRA meeting: COVID-19 Real-World Evidence and Observational studies
22 April 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
8 April 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
25 March 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
4 March 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
10 February 2021 ICMRA COVID-19 Virus Variants Workshop Meeting note
9 February 2021 ICMRA Pregnancy and Lactation Workshop Meeting note
4 February 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
25 January 2021 International regulatory workshop on observational studies and real-world data ICMRA meeting: COVID-19 Real-World Evidence and Observational studies
21 January 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
13 January 2021 ICMRA Vaccine Safety Collaboration Workshop Meeting note
7 January 2021 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
15 December 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
3 December 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
12 November 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
29 October 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
15 October 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
13 October 2020 International regulatory workshop on observational studies and real-world data Strengthening global collaboration on COVID-19 real-world evidence and observational studies
1 October 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
17 September 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
3 September 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
20 August 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
6 August 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
23 July 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
22 July 2020 International regulatory workshop on observational studies and real-world data Global regulatory workshop on COVID-19 real-world evidence and observational studies
20 July 2020 International regulatory workshop on development of COVID-19 treatments Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials
9 July 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
26 June 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
22 June 2020 International regulatory workshop on development of COVID-19 vaccines

Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines

International regulators align positions on phase 3 COVID-19 vaccine trials

12 June 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
27 May 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
19 May 2020 International regulatory workshop on COVID-19 real-world evidence and observational studies Global regulators commit to cooperate on observational research in the context of COVID-19
14 May 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
30 April 2020 Strategic meeting Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
16 April 2020 Strategic meeting ICMRA aims for international alignment on policy approaches and regulatory flexibility during COVID-19 pandemic
6 April 2020 International regulatory workshop on observational studies and real-world data Global regulators discuss observational studies of real world data for COVID-19 medicines
2 April 2020 International regulatory workshop on development of COVID-19 treatments Global regulators stress need for robust evidence on COVID-19 treatments
18 March 2020 International regulatory workshop on development of COVID-19 vaccines Global regulators map out data requirements for phase 1 COVID-19 vaccine trials


 

Information on COVID-19 from ICMRA members

ICMRA members provide information on their responses to the COVID-19 pandemic on their own websites. This information is available in a range of languages.

 

Organisation COVID-19 information Languages
European Medicines Agency Coronavirus disease (COVID-19) English
Pharmaceuticals and Medical Devices Agency (PMDA) PMDA’s Efforts to Combat COVID-19 English
Japanese
Swedish Medical Products Agency Läkemedelsverkets arbete i samband med utbrottet av coronavirus/covid-19 Swedish
Health Canada COVID-19 Health Product Industry English
French
Italian Medicines Agency (AIFA) Emergenza COVID-19 Italian
Danish Medicines Agency (DKMA) Ny coronavirus (COVID-19)
Overview of planned or ongoing studies of drugs for the treatment of COVID-19

Danish
English

Therapeutic Goods Administration (TGA) Coronavirus (COVID-19): Information on medicines and medical devices English
Medicines and Healthcare products Regulatory Agency (MHRA)  MHRA guidance on coronavirus (COVID-19) English
Saudi Food & Drug Authority (SFDA) Corona virus (COVID-19) Arabic
English

 

 

Promoting confidence in vaccines

In June 2020, ICMRA issued joint statements about the importance, safety and effectiveness of vaccines. The two ICMRA statements aim to reassure healthcare professionals and the public around the globe that medicines regulators only allow vaccines onto the market that fulfil the highest standards of safety, efficacy and quality.