EMA's work on public health emergencies

The European Medicines Agency (EMA) has developed a health threats plan describing how it operates during an emerging health threat. The plan sets out the roles and responsibilities of EMA's scientific committees and staff during a public health threat. This enables a rapid and efficient response.

The overall aim of EMA's health threats plan is to:

• initiate and coordinate scientific and regulatory activities by involving all interested parties at EMA and in the European medicines regulatory network - this includes expert groups, national competent authorities and the European Commission as well as the European Centre for Disease Control (ECDC) and Official Medicines Control Laboratories (OMCLs), where relevant;
• prepare and convene EMA's Emergency Task Force (ETF) to manage and coordinate discussions on the development, authorisation and surveillance of medicines to be used to address the health threat;
• provide EU partners the outcome of the review of medicines;
• provide support to international partners, stakeholders involved in the research and development of medicines and public health authorities outside Europe, such as the World Health Organization (WHO).

The health threats plan also describes EMA's communication with EU Member States, international partners, stakeholders and the public in the event of a crisis.

In addition, the plan covers operational aspects such as providing fast-track approval of medicines like vaccines and antivirals. This is to prevent or treat a disease caused by an emerging virus.

Planning for, responding to and communicating on serious health threats are priorities in the European medicines agencies network strategy. This helps complement ongoing European Commission initiatives in this area.

EMA plan for emerging health threats

Reference Number: EMA/864626/2022 Rev. 1

For more information, see:

• Crisis preparedness and management

Bringing together best expertise

EMA can convene its Emergency Task Force (ETF), a dedicated advisory and support body to handle regulatory activities in preparation for and during a declared public health emergency such as the COVID-19 pandemic. 

The ETF brings together regulators based on their expertise on the health threat causing a potential or confirmed public-health emergency.

EMA set up the ETF in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).

EMA can also call upon additional European experts to support the ETF with specialised knowledge in areas such as: 

• Antimicrobial resistance
• Biological and chemical agents used maliciously
• Infectious diseases
• Vaccines
• Clinical trial design 

These experts contribute to the activities of the ETF in delivering a global response to public health threats.

For more information, see:

• European experts

Facilitating development of medicines and vaccines

EMA can mobilise a number of tools to help speed up the development of medicines and vaccines in the event of an emerging threat or an outbreak, depending on the circumstances. These include:

• Providing guidance and scientific advice on the tests and studies needed to develop new medicines such as antimicrobial treatments and medicines or vaccines to combat an outbreak
• Providing scientific support to facilitate larger multinational clinical trials for medicines addressing public-health emergencies
• Encouraging new approaches by organising scientific workshops and publishing reflection papers
• Issuing opinions on medicines intended for use outside the European Union (EU) under the 'EU-M4Aall' procedure 

Support for treatment and vaccine developers

EMA is committed to establishing close contact with developers of treatments or vaccines for emerging health threats.

Developers of treatments and vaccines targeting infectious diseases and threats that could cause a public health emergency should contact EMA's ETF at [e-mail].

Developers should include a description of the candidate product, its development plan and a summary of available evidence.

Establishing contact early in the development process is important to ensure that developers can submit well-prepared applications.

Support for clinical trial sponsors

For queries on the support available for multinational clinical trials in the EU, sponsors should contact EMA’s ETF at [e-mail].

For more information, see:

• Clinical trial management for public health emergencies

Working with international partners

EMA works closely with European and international partners such as the European Commission, World Health Organization (WHO) and European Union agencies. 

EMA's partner list includes the European Centre for Disease Prevention and Control (ECDC). This partnership helps address existing and emerging threats as well as public health emergencies.

In addition, EMA is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), which serves as a hub for global regulatory collaboration during health crises.

Preparing for a potential health threat

EMA can convene its ETF in preparation for a potential health threat in order to ensure an adequate and robust response to the threat.

In line with the ETF's mandate, the Emergency Task Force can carry out the following preparatory activities:

• Monitoring outbreaks and epidemics with the potential to become public-health emergencies
• Liaising with EMA's committees, working parties and advisory groups - in order to identify possible regulatory actions
• Providing scientific advice on the development of medicines that have the potential to address a future public health emergency - this includes providing advice on the use of platform trials
• Developing requirements and strategies for vaccines and treatments for emerging pathogens - in order to facilitate the regulatory process for emerging medicines
• Maintaining an overview of medicines that can help address the potential health threat
• Maintaining information on potential radiological, chemical or bioterror agents that may be released accidentally or deliberately - in cases of terrorism

For more information, see:

• Crisis preparedness and management
• Biological and chemical threats

Transparency during public health emergencies

EMA published an overview of the information it makes available on the development, evaluation and supervision of medicines required in a public health emergency.

The aim of this document is to:

• inform the general public about the transparency measures that EMA applies during public health emergencies, such as shortening publishing timelines;
• help medicines developers take advantage of existing incentives and programmes meant to speed up the development and evaluation of medicines.

During public health emergencies, EMA goes beyond its standard transparency measures in order to address high public interest in medicines. 

The Agency’s response to the COVID-19 pandemic is a prime example. This includes exceptional transparency measures and accelerated procedures.

EMA transparency measures for medicines addressing public health emergencies

Reference Number: EMA/244151/2020

For more information, see:

• Transparency: exceptional measures for COVID-19 medicines
• COVID-19 guidance: evaluation and marketing authorisation: Rapid procedures