Strategia farmaceutyczna dla Europy Przyjęta 25listopada 2020r. Strategia farmaceutyczna dla Europy (wersja przyjazna dla czytelnika) służy stworzeniu ram regulacyjnych, które nie… 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… Produkty lecznicze UE jest światowym liderem przemysłu farmaceutycznego i największym światowym uczestnikiem rynku środków farmaceutycznych i produktów leczniczych… Eudralex The body of European Union legislation in the pharmaceutical sector is compiled in… Union Register The Union Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing… Latest updatesNews announcement | 4 maj 2022Agenda - 99th meeting of the Pharmaceutical Committee (11 May 2022)News announcement | 13 kwiecień 2022Questions and Answers Document – Regulation (EU) 536/2014 – Version 6 April 2022)News announcement | 24 marzec 2022Summary record - 98th meeting of the Pharmaceutical Committee (20 January 2022)News announcement | 7 marzec 2022Presentations and recording - HPP webinar: “Political and legal issues linked to financing the development of pharmaceuticals all along their life-cycle” (03 March 2021)See 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) Events03LUT2022 Spotkania partnerskie Joint action on support to coordinated and expedited assessment of clinical trials for COVID-19 therapeutics08LIS2021 Spotkania partnerskie Joint EMA/HMA-CTFG/COM training about IT support for safety cooperation in clinical trials16CZE2021 Spotkania partnerskie Structured Dialogue initiative - 2nd Event09-10MAR2021 Spotkania partnerskie EC-DG SANTE/HMA-CTFG/EMA joint training on the Clinical Trials Regulation (EU) 536/2014 DocumentsEventsConsultationsPublicationsVideosEurobarometers
News announcement | 13 kwiecień 2022Questions and Answers Document – Regulation (EU) 536/2014 – Version 6 April 2022)
News announcement | 24 marzec 2022Summary record - 98th meeting of the Pharmaceutical Committee (20 January 2022)
News announcement | 7 marzec 2022Presentations and recording - HPP webinar: “Political and legal issues linked to financing the development of pharmaceuticals all along their life-cycle” (03 March 2021)
Notice to stakeholders - Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic (updated 1 July 2020)
03LUT2022 Spotkania partnerskie Joint action on support to coordinated and expedited assessment of clinical trials for COVID-19 therapeutics
08LIS2021 Spotkania partnerskie Joint EMA/HMA-CTFG/COM training about IT support for safety cooperation in clinical trials
09-10MAR2021 Spotkania partnerskie EC-DG SANTE/HMA-CTFG/EMA joint training on the Clinical Trials Regulation (EU) 536/2014
