COVID-19

Between 2020 and 2023, the COVID-19 pandemic was a Public Health Emergency of International Concern (PHEIC), as declared by the World Health Organization (WHO). During that period, ICMRA acted as a forum to support strategic coordination and international cooperation among global medicine regulatory authorities.

The aim of the activities was to expedite and streamline the development, authorisation and availability of COVID-19 treatments and vaccines worldwide and to cooperate on the assessment of their safety. ICMRA members also worked towards increasing the efficiency of regulatory processes and decision making.

The WHO declared in May 2023 that COVID-19 no longer constituted a public health emergency of international concern. Instead, it was deemed an established and ongoing health issue which remains a global health threat. ICMRA is fully committed to coordinating a global response to future challenges and to ensure that new or adapted vaccines and therapeutics can be made available as needed and that their safety is ensured.

ICMRA achievements during the COVID-19 pandemic

 

ICMRA pledges and statements related to COVID-19

TitleTopicPublication date
ICMRA statement on the safety of COVID-19 vaccinesVaccine, Safety5 July 2023
International Coalition of Medicines Regulatory Authorities COVID-19 Working Group - Summary of Achievements*Global collaboration21 October 2022
[Revised] Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness*Vaccine, Variants, Boosters,
Healthcare professionals,
Children, Pregnancy		17 May 2022
Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 pandemicRemote inspections10 December 2021
ICMRA statement on need for continued focus on COVID-19 therapeutics*Therapeutics10 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 membersRegulatory flexibilities, Emergency use10 December 2021
Report on regulatory flexibilities implemented by national regulatory authorities during the pandemicRegulatory flexibilities3 December 2021
ICMRA Statement on Pre-Requisites for Regulatory Flexibility in Pharmaceutical Manufacturing Change ManagementRegulatory flexibilities, Pharmaceutical quality, Manufacturing12 October 2021
[Revised] Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness*Vaccines, 
Healthcare professionals		11 June 2021
Joint Statement on transparency and data integrity*Transparency7 May 2021
ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness*Vaccines, 
Healthcare professionals		19 January 2021
ICMRA statement on continuation of vaccine trials*Vaccines27 November 2020
WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines*Vaccines, Therapeutics6 November 2020
ICMRA statement on clinical trials: International regulators provide guidance on prioritisation of COVID-19 clinical trialsClinical trials24 June 2020
ICMRA statement about confidence in vaccines (for the general public)*
ICMRA statement about confidence in vaccine safety and effectiveness (for healthcare professionals)*		Vaccines,
Healthcare professionals		17 June 2020
ICMRA statement on COVID-19: International regulators pledge collective support to combat COVID-19Global collaboration28 April 2020

* Available in multiple languages

 

COVID-19 meetings and workshops

During the pandemic, ICMRA members held a series of initially bi-weekly and later monthly strategic meetings (COVID-19 Policy Teleconferences) to discuss international alignment on COVID-19 policies. 
These also focused 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.

Between 2020 and 2023, ICMRA also held international regulatory workshops on important topics to allow for in-depth discussions and to agree on common approaches. In addition to delegates representing more than 30 medicines regulatory authorities globally, participants include experts from the World Health Organization and the European Commission.

 

Calendar of meetings and workshops

DateEventMore information
26-27 February 2024ICMRA/WHO COVID-19 vaccines strain update workshopMeeting report
26 February 2024ICMRA meeting: COVID-19 Real World Evidence and Observational studiesMeeting report
11 September 2023ICMRA meeting: COVID-19 Real World Evidence and Observational studiesMeeting report
8 May 2023ICMRA COVID-19 Omicron variant workshopMeeting report
30 June 2022ICMRA COVID-19 Virus Variants WorkshopMeeting report
20 May 2022International regulatory workshop on observational studies and real-world dataMeeting report
12 January 2022ICMRA COVID-19 Omicron Variant WorkshopMeeting report
7-8 July 2021ICMRA 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 2021ICMRA COVID-19 Virus Variants Workshop

Meeting report

Presentations

10 May 2021International regulatory workshop on observational studies and real-world dataMeeting report
10 February 2021ICMRA COVID-19 Virus Variants WorkshopMeeting report
9 February 2021ICMRA Pregnancy and Lactation WorkshopMeeting report
25 January 2021International regulatory workshop on observational studies and real-world dataMeeting report
13 January 2021ICMRA Vaccine Safety Collaboration WorkshopMeeting report
13 October 2020International regulatory workshop on observational studies and real-world dataStrengthening global collaboration on COVID-19 real-world evidence and observational studies
22 July 2020International regulatory workshop on observational studies and real-world dataGlobal regulatory workshop on COVID-19 real-world evidence and observational studies
20 July 2020International regulatory workshop on development of COVID-19 treatmentsGlobal regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials
22 June 2020International 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 2020The COVID-19 Policy TeleconferenceMeeting report
27 May 2020The COVID-19 Policy TeleconferenceMeeting report
19 May 2020International regulatory workshop on COVID-19 real-world evidence and observational studiesGlobal regulators commit to cooperate on observational research in the context of COVID-19
14 May 2020The COVID-19 Policy TeleconferenceMeeting report
30 April 2020The COVID-19 Policy TeleconferenceMeeting report
16 April 2020The COVID-19 Policy TeleconferenceMeeting report
6 April 2020International regulatory workshop on observational studies and real-world dataGlobal regulators discuss observational studies of real world data for COVID-19 medicines
2 April 2020International regulatory workshop on development of COVID-19 treatmentsGlobal regulators stress need for robust evidence on COVID-19 treatments
18 March 2020International regulatory workshop on development of COVID-19 vaccinesGlobal regulators map out data requirements for phase 1 COVID-19 vaccine trials