Strategia farmaceutica per l'EuropaAdottata il 25 novembre 2020, la strategia farmaceutica per l'Europa (versione di facile lettura) mira a creare un quadro normativo adatto al futuro…Legal frameworkThe 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 ChildrenThe Paediatric Regulation has governed the development and authorisation of medicines for paediatric use since entering into force in 2007. Its…Orphan medicinal productsPatients suffering from rare diseases deserve the same quality of treatment as other patients within the European Union. Given the small numbers of…Advanced TherapiesAdvanced therapy refers to new medical products that use gene therapy, cell therapy, and tissue engineering. They can be used to treat diseases or…Pharmaceutical CommitteePharmaceutical Committee, Veterinary Pharmaceutical Committee. The Pharmaceutical Committee is an advisory Committee which was set up by Council…Clinical trialsClinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational…Falsified medicinesFalsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they…EU logoThe 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 PracticesGood Manufacturing Practices (GMP). The manufacture or import of medicinal products is subject to manufacturing or import authorisation. The…PharmacovigilancePharmacovigilance 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 ProductsEU legislation on pharmaceutical products for human use also applies to traditional herbal medicines. Herbal medicinal products are defined as any…Personalised medicinePersonalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals…Pharmaceuticals and the EnvironmentEnvironmental Pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem. Article 8c of Directive 2008…Call for EMA committees and board membersOpen callsCivil Society representatives: Call for expressions of interest is open for the EMA Management Board. The Commission is launching a selection…PharmaceuticalsThe EU is a global leader in the pharmaceutical industry and the world's biggest trader in pharmaceuticals and medicinal products.As the industry…EudralexThe body of European Union legislation in the pharmaceutical sector is compiled in…Union RegisterThe Union Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing… Latest updatesNews announcement30 gennaio 2023Quick guide for sponsors - Regulation 536/2014 in practice (Eudralex vol. 10)News announcement30 gennaio 2023Presentations and video recordings - Multistakeholder Event on Biosimilar medicines (13 December 2022)News announcement26 gennaio 2023Improving the quality of medicines News announcement23 gennaio 2023Clinical Trials: EU survey on the implementation of the Clinical Trial RegulationSee all HighlightsStructured dialogue on security of medicines supplyEU Strategy on COVID-19 TherapeuticsEvaluation of the medicines for rare diseases and children legislationNotices to stakeholders - Withdrawal of the United Kingdom from the EULabelling and packaging flexibilities for COVID-19 vaccinesNotice to stakeholders - Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic (updated 1 July 2020) Events03feb2022Riunioni dei partnerJoint action on support to coordinated and expedited assessment of clinical trials for COVID-19 therapeutics23-24set2010Riunioni dei partnerMinisterial Conference "Innovation and Solidarity"17giu2019Riunioni dei partnerConference “Medicines for rare diseases and children: learning from the past, looking to the future”07feb2023Riunioni dei partnerWebinar on Best practices in the public procurement of medicines DocumentsEventsConsultationsPublicationsVideosEurobarometers
Strategia farmaceutica per l'EuropaAdottata il 25 novembre 2020, la strategia farmaceutica per l'Europa (versione di facile lettura) mira a creare un quadro normativo adatto al futuro…
Legal frameworkThe 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 ChildrenThe Paediatric Regulation has governed the development and authorisation of medicines for paediatric use since entering into force in 2007. Its…
Orphan medicinal productsPatients suffering from rare diseases deserve the same quality of treatment as other patients within the European Union. Given the small numbers of…
Advanced TherapiesAdvanced therapy refers to new medical products that use gene therapy, cell therapy, and tissue engineering. They can be used to treat diseases or…
Pharmaceutical CommitteePharmaceutical Committee, Veterinary Pharmaceutical Committee. The Pharmaceutical Committee is an advisory Committee which was set up by Council…
Clinical trialsClinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational…
Falsified medicinesFalsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they…
EU logoThe 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 PracticesGood Manufacturing Practices (GMP). The manufacture or import of medicinal products is subject to manufacturing or import authorisation. The…
PharmacovigilancePharmacovigilance 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 ProductsEU legislation on pharmaceutical products for human use also applies to traditional herbal medicines. Herbal medicinal products are defined as any…
Personalised medicinePersonalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals…
Pharmaceuticals and the EnvironmentEnvironmental Pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem. Article 8c of Directive 2008…
Call for EMA committees and board membersOpen callsCivil Society representatives: Call for expressions of interest is open for the EMA Management Board. The Commission is launching a selection…
PharmaceuticalsThe EU is a global leader in the pharmaceutical industry and the world's biggest trader in pharmaceuticals and medicinal products.As the industry…
Union RegisterThe Union Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing…
News announcement30 gennaio 2023Quick guide for sponsors - Regulation 536/2014 in practice (Eudralex vol. 10)
News announcement30 gennaio 2023Presentations and video recordings - Multistakeholder Event on Biosimilar medicines (13 December 2022)
News announcement23 gennaio 2023Clinical Trials: EU survey on the implementation of the Clinical Trial Regulation
Notice to stakeholders - Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic (updated 1 July 2020)
03feb2022Riunioni dei partnerJoint action on support to coordinated and expedited assessment of clinical trials for COVID-19 therapeutics
17giu2019Riunioni dei partnerConference “Medicines for rare diseases and children: learning from the past, looking to the future”
