Paul-Ehrlich-Institut

In­ter­na­tion­al Coali­tion of Medicines Reg­u­la­to­ry Agen­cies (ICM­RA) State­ments with Par­tic­i­pa­tion of the Paul-Ehrlich-In­sti­tut

The International Coalition of Medicines Regulatory Agencies (ICMRA) is an organisation composed of 29 medicines authorities from regions all over the world with the World Health Organisation (WHO) as the observer. As one of its aims, ICMRA intends to facilitate the world-wide access to safe, efficacious, and high-quality medicines that are indispensable for the health and well-being of the people. This includes making standards compatible with scientific progress, advancing decision-making processes, and maintaining efficient regulation processes and their convergence. The latter regulation processes are designed to support the development and provision of medicines while ensuring that the benefit of these products outweighs the risks relating to them.

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines is a member of this coalition and expressly supports the ICMRA initiatives.

12/02/21 Statement ICMRA (adressing HCP) – Regulating COVID-19 vaccines in terms of safety and effectiveness

Healthcare professionals and public health authorities will have a central role in discussing vaccination against COVID-19 with their patients.

This statement explains the regulatory processes associated with the review of COVID-19 vaccines for safety, efficacy and quality. It also explains the arrangements put in place both nationally and globally for ongoing safety monitoring of different COVID-19 vaccines once they are on the market.

06/11/20 WHO and ICMRA – Joint Statement on Global Standards for the Regulation of COVID-19 Medicines and Vaccines

A large number of COVID-19 vaccines and treatments are under development or aiming for approval. The World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) have joined forces to promote globally coordinated, evidence-based regulatory processes. Multilateral cooperation between the regulatory authorities is necessary to ensure the safety, efficacy and quality of COVID-19 medicines and vaccines worldwide – so that all countries may benefit equitably, at the same time.

24/06/20 Statement ICMRA - High Standards for Clinical Trials Worldwide

The International Coalition of Medicines Regulatory Authorities (ICMRA) has pledged its collective support in countering the global COVID-19 pandemic: ICMRA members have an important role to play in supporting the worldwide effort to fight COVID-19 pandemic. The members have stepped up their global collaboration to facilitate and expedite the development and evaluation of diagnostics and therapeutics, including possible vaccines, against SARS-CoV-2. This statement is intended for all stakeholders, patients, investigators, researchers, academia, regulators, and the pharmaceutical industry.

17/06/20 Statement ICMRA Statement – Confidence in Vaccines

Vaccines can prevent more than two million deaths every year. The International Coalition of Medicines Regulatory Agencies, ICMRA has published a statement emphasising the importance of vaccines for public health. The international authorities show that the quality, efficacy and safety of vaccines are tested and ensured at a high level world-wide and that the benefit of a vaccination by far outweighs the possible risks involved with such a vaccination. The aim is to strengthen the acceptance of vaccinations as an important preventive step towards protecting the population from infectious diseases.

28/04/20 Statement ICMRA - Corona Pandemic SARS-CoV-2 / COVID-19

The International Coalition of Medicine Regulatory Agencies, ICMRA is intensifying the international co-operation of medicines authorities. In view of the current crisis, the aim is to advance the development, marketing authorisation, supervision, and world-wide availability of safe and efficacious vaccines, therapeutics, and diagnostic devices for the treatment of and testing for COVID-19.

The members of ICMRA have agreed upon the following:

  • to harmonise the criteria for the development, marketing authorisation and testing (regulation) for SARS-CoV-2 vaccine candidates and medicines for the treatment of COVID-19 world-wide and to facilitate and expedite their development and transfer into clinical trials.
  • to co-operate with manufacturers, companies, and distributors to find a joint approach to resolving problems with medicines supplies, supply shortages, and reduced production capacities. Companies must co-operate closely and complement each other to reduce the consequences of the pandemic both on a world-wide and on an individual basis.
  • to monitor the market as soon as a medicinal product has been authorised to ensure that its use continues to outweigh its possible risks.
  • to speak out in favour of fair access to clinical trials, vaccines, medicines, and diagnostic devices for countries affected by COVID-19. Solutions shall always follow a global approach.
  • to co-operate closely to support the rapid development of diagnostic tests for COVID-19, and to ensure the comparability of the results and approaches for the implementation.

Updated: 16.02.2021