Farmaceutická strategie pro EvropuDne 25. listopadu 2020 byla přijata Farmaceutická strategie pro Evropu (přehledný souhrn). Jejím cílem je vytvořit stálý regulační rámec a podporovat…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…Farmaceutické výrobkyEU má vefarmaceutickém průmyslu v globálním měřítku vedoucí pozici aje největší světovou obchodní velmocí voblasti léčiv aléčivých přípravků.Vzhledem…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 announcement26 leden 2023Improving the quality of medicines News announcement23 leden 2023Clinical Trials: EU survey on the implementation of the Clinical Trial RegulationNews announcement18 leden 2023Agenda and Pre-registration - Webinar on Best practices in the public procurement of medicines (7 February 2023, 10:00-12:30 CET)News announcement19 prosinec 2022EU Guideline on orphan applications (for designation and transfer) - 2022/C 440/02See 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) Events07úno2023Setkání partnerských subjektůWebinar on Best practices in the public procurement of medicines13pro2022Setkání partnerských subjektůBiosimilar medicines - Multistakeholder Event03úno2022Setkání partnerských subjektůJoint action on support to coordinated and expedited assessment of clinical trials for COVID-19 therapeutics08lis2021Setkání partnerských subjektůJoint EMA/HMA-CTFG/COM training about IT support for safety cooperation in clinical trials DocumentsEventsConsultationsPublicationsVideosEurobarometers
Farmaceutická strategie pro EvropuDne 25. listopadu 2020 byla přijata Farmaceutická strategie pro Evropu (přehledný souhrn). Jejím cílem je vytvořit stálý regulační rámec a podporovat…
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…
Farmaceutické výrobkyEU má vefarmaceutickém průmyslu v globálním měřítku vedoucí pozici aje největší světovou obchodní velmocí voblasti léčiv aléčivých přípravků.Vzhledem…
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 announcement23 leden 2023Clinical Trials: EU survey on the implementation of the Clinical Trial Regulation
News announcement18 leden 2023Agenda and Pre-registration - Webinar on Best practices in the public procurement of medicines (7 February 2023, 10:00-12:30 CET)
News announcement19 prosinec 2022EU Guideline on orphan applications (for designation and transfer) - 2022/C 440/02
Notice to stakeholders - Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic (updated 1 July 2020)
07úno2023Setkání partnerských subjektůWebinar on Best practices in the public procurement of medicines
03úno2022Setkání partnerských subjektůJoint action on support to coordinated and expedited assessment of clinical trials for COVID-19 therapeutics
08lis2021Setkání partnerských subjektůJoint EMA/HMA-CTFG/COM training about IT support for safety cooperation in clinical trials
