International Coalition of Medicines Regulatory Authorities (ICMRA)

Updated: 17/05/2022

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

Antimicrobial Resistance Best Practices

(Also available in French)

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.

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.

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.

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. 

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.

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.

Joint Statement on transparency and data integrity

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.

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 statement for patients and healthcare professionals on vaccine confidence and vaccine safety and effectiveness (available in 7 languages)

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. 

ICMRA statement from global medicines regulators on combatting antimicrobial resistance

(Also available in French, Spanish and Portuguese)

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.