Paul-Ehrlich-Institut

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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 Organization (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.

05/07/23 ICMRA Statement – Safety of COVID-19 vaccines

The International Coalition of Medicines Regulatory Authorities (ICMRA) has issued a statement highlighting the safety and benefits of the COVID-19 vaccines and addressing some of the most common pieces of misinformation about the safety of the COVID-19 vaccines.

Key points from ICMRA:

  • COVID-19 vaccines significantly reduce the risk of severe disease, hospitalisation and death from infection with SARS-CoV-2.
  • SARS-CoV-2 keeps changing and revaccination may be needed to maintain protection against new variants and continue saving millions of lives worldwide.
  • Evidence from the more than 13 billion vaccine doses given worldwide shows that COVID-19 vaccines have a very good safety profile in all age groups. The benefits of the approved vaccines far outweigh the possible risks.
  • The vast majority of side effects are mild and temporary. However, safety monitoring (pharmacovigilance) systems have identified some very rare (occurring in less than 1 in 10,000 people) but serious side effects. Medicines regulators around the world have put in place measures to reduce the risk of harm from these side effects.
  • As for all medicines, reports of medical events after COVID-19 vaccination (suspected side effects) are collected and continuously evaluated by the authorities. These evaluations show that in most cases the medical events were not caused by the vaccine.
  • False and misleading information about the safety of COVID-19 vaccines on social media often exaggerates the frequency and severity of side effects. Misinformation also wrongly attributes unrelated medical events to the vaccines. Vaccine misinformation leading individuals to decline vaccination has very likely led to many more deaths than adverse effects of the vaccines.
  • There is no evidence that COVID-19 vaccines have contributed to excess mortality during the pandemic. Excess mortality largely coincides with peaks of SARS-CoV-2 infections, particularly during the first waves when vaccines were not available. In fact, there is strong evidence that COVID-19 vaccines save lives and prevent the serious harm associated with SARS-CoV-2 infection.
  • Emerging evidence also suggests that long COVID is less likely to develop in people who have been vaccinated.

ICMRA provides more detailed information in its statement on the benefits and safety of COVID-19 vaccines and on vaccinations with COVID-19 vaccines in certain population groups, such as pregnant women, children, or people with weakened immune systems (see further information).

10/12/21 ICMRA COVID-19 Working Group reflections on remote GCP and GMP regulatory authority inspections

The International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group in August 2020 to consider the use of remote GCP and GMP inspections during the pandemic.

The resulting reflection paper, which was created in collaboration with the Paul-Ehrlich-Institut, provides valuable insights into the regulatory authorities' experiences with remote inspections during the pandemic.

The ICMRA working group, chaired by the MHRA, includes international representatives from the US FDA, EMA, Health Canada, Swiss-medic, HPRA in Ireland, AEMPS in Spain, ANSM in France, Paul-Ehrlich-Institut in Germany, MHLW/PMDA in Japan, TGA in Australia, ANVISA in Brazil, HSA in Singapore, WHO and Saudi FDA.

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: 21.07.2023