Przyjęta 25 listopada 2020 r. strategia farmaceutyczna dla Europy (wersja przyjazna dla czytelnika) służy stworzeniu ram regulacyjnych, które nie ulegną łatwo dezaktualizacji...

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…

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

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

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

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

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

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

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

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

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

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

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