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, the risk of falsified medicines, biological and chemical threats and emergencies such as an outbreak or a pandemic. The Agency has a number of mechanisms to contribute to a global repsonse to combat these challenges.
Bringing together best expertise
EMA can bring together and support groups of European experts who have specialised knowledge in areas such as antimicrobial resistance, biological and chemical agents used maliciously, infectious diseases, vaccines and clinical trial design to contribute to a global response.
These groups can also give advice to medicine or vaccine developers on scientific and regulatory matters.
Facilitating development of medicines and vaccines
EMA has a number of mechanisms and tools which can potentionally be used to help speed up the development of medicines and vaccines to limit the development of an emerging threat or in the context of 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 antibmicrobial treatments and medicines or vaccines to combat an outbreak;
- 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;
- using orphan designation.
EMA is committed to establishing close contact with developers of treatments or vaccines for emerging major health threats.
Working with international partners
EMA works closely with European and international partners, including the European Commission, the World Health Organization and European Union agencies, including the European Centre for Disease Prevention and Control, to address existing and emerging threats and during public health emergencies.
The Agency is also cooperating with international anti-counterfeiting trade agreements and other criminal-law instruments, such as the Council of Europe's Medicrime convention and the Organisation for Economic Co-operation and Development (OECD) project on counterfeiting and piracy.