En lægemiddelstrategi for Europa

Lægemiddelstrategien for Europa (læsevenlig udgave), der blev vedtaget den 25. november 2020, har til formål at skabe et fremtidssikret regelsæt og…

Legal framework

The EU legal framework for human medicines sets standards to ensure a high level of public health protection and the quality, safety and efficacy of…

Medicines for Children

The Paediatric Regulation has governed the development and authorisation of medicines for paediatric use since entering into force in 2007. Its…

Orphan medicinal products

Patients suffering from rare diseases deserve the same quality of treatment as other patients within the European Union. Given the small numbers of…

Advanced Therapies

Advanced therapy refers to new medical products that use gene therapy, cell therapy, and tissue engineering. They can be used to treat diseases or…

Pharmaceutical Committee

Pharmaceutical Committee, Veterinary Pharmaceutical Committee. The Pharmaceutical Committee is an advisory Committee which was set up by Council…

Clinical trials

Clinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational…

Falsified medicines

Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they…

EU logo

The illegal sale of medicinal products via the Internet is a serious threat to public health and safety as falsified medicinal products may easily…

Good Manufacturing and Distribution Practices

Good Manufacturing Practices (GMP). The manufacture or import of medicinal products is subject to manufacturing or import authorisation. The…

Pharmacovigilance

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of…

Herbal Medicinal Products

EU legislation on pharmaceutical products for human use also applies to traditional herbal medicines. Herbal medicinal products are defined as any…

Personalised medicine

Personalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals…

Pharmaceuticals and the Environment

Environmental Pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem. Article 8c of Directive 2008…

Call for EMA committees and board members

Open callsCivil Society representatives: Call for expressions of interest is open for the EMA Management Board. The Commission is launching a selection…