Public health threats
The European Medicines Agency (EMA) is committed to supporting global efforts to respond to existing and emerging public health threats, such as antimicrobial resistance, biological and chemical threats and emergencies such as outbreaks or pandemics. The Agency has a number of mechanisms in place to contribute to global responses to such challenges.
EMA has developed a health threats plan describing how the Agency operates during an emerging health threat, allowing for a rapid and efficient response:
The plan sets out the roles and responsibilities of EMA's scientific committees and staff during a public health threat.
The overall aim of the plan is to:
- initiate and coordinate scientific and regulatory activities by involving all interested parties at EMA and in the European medicines regulatory network, including 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 to public health authorities outside Europe, for example the World Health Organization (WHO).
The plan also describes EMA's communication with the EU Member States, international partners, stakeholders and the public in the event of a crisis.
It also covers operational aspects such as providing fast-track approval of medicines such as vaccines and antivirals to prevent or treat a disease caused by an emerging virus.
Planning for, responding to and communicating on serious health threats is a priority in the European medicines agencies network strategy and complements ongoing European Commission initiatives in this area.
EMA can convene 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. This 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).
For more information, see:
EMA can also call upon additional European experts with specialised knowledge in areas such as antimicrobial resistance, biological and chemical agents used maliciously, infectious diseases, vaccines and clinical trial design to contribute to the activities of the ETF in delivering a global response to public health threats.
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 'Article 58' procedure;
Support for treatment and vaccine developers
Update: 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 (as listed in annex I of the ETF Workplan) should contact EMA's ETF at PHEearlyinteractions@ema.europa.eu.
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 for ensuring that developers can submit well-prepared applications.
Support for clinical trial sponsors
EMA works closely with European and international partners, including the European Commission, World Health Organization and European Union agencies, including the European Centre for Disease Prevention and Control, to address existing and emerging threats as well as during 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.
EMA can convene its ETF in preparation for a potential health threat in order to ensure an adequate and robust response to the threat.
This is in line with the ETF's mandate.
The ETF can carry out the following activities in preparation for a potential health threat:
- Monitoring outbreaks and epidemics with the potential to become public-health emergencies
- Liaising with EMA's committees, working parties and advisory groups to identify possible regulatory actions to address the potential public health emergency
- 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)
Update: For queries on the support available for developers of treatments or vaccines and sponsors of clinical trials, see:
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 as it includes exceptional transparency measures and accelerated procedures. For more information, see: