Europe

The EU through its executive branch, the European Commission, promotes Health technology assessment (HTA) by making policies and funding policies aimed at strengthening HTA in Europe. Around fifteen of the European countries have formal national programs on HTA and some also have regional public programs. Moreover, those EU member-countries that do not have a national approach to HTA have developed an interest in becoming more involved. The main focus of HTA projects sponsored by the European Commission is networking and collaboration among established agencies and institutions for HTA, as well as on capacity building, support, and facilitating the development of HTA mechanisms in European countries that still do not have any program in the field.


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018

16/02/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018 CVMP recommends changes to product information for some veterinary medicines containing enrofloxacin, to reduce development of antimicrobial resistance in target pathogens CVMP opinions on veterinary medicinal products The Committee adopted by consensus positive opinions for initial […]


Publication of final project plan of the assessment on “Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery”

Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery The publication of the final project plan of the assessment on “Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery” and the comments provided by one manufacturer during fact check of […]


News and press releases: Veterinary medicines: highlights of 2017

News 13/02/2018 Veterinary medicines: highlights of 2017 18 medicines recommended for marketing authorisation, including ten vaccines The European Medicines Agency (EMA) has published an overview of its key recommendations of 2017, including for marketing authorisations of new veterinary medicines. In 2017, EMA recommended 18 medicines for marketing authorisation, an increase […]


News and press releases: Regulatory information – adjusted fees for pharmacovigilance applications to EMA from 12 February 2018

12/02/2018 Regulatory information – adjusted fees for pharmacovigilance applications to EMA from 12 February 2018 Pharmacovigilance fees increase by 1.4% Pharmacovigilance fees payable to the European Medicines Agency (EMA) by applicants and marketing authorisation holders increase by 1.4% as of 12 February 2018, to reflect inflation rate adjustments of 0.2% […]


News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2018

09/02/2018 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2018 PRAC gives recommendations for valproate, flupirtine, retinoids and interim advice for Esmya PRAC recommends new measures to avoid valproate exposure in pregnancy The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures to avoid exposure of babies […]


News and press releases: PRAC recommends new measures to avoid valproate exposure in pregnancy

09/02/2018 PRAC recommends new measures to avoid valproate exposure in pregnancy New restrictions on use; pregnancy prevention programme to be put in place The European Medicines Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC) are recommending new measures to avoid exposure of babies to valproate medicines in […]


News and press releases: Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing

09/02/2018 Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing No new patients should start treatment for the time being EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver […]


Proposed Regulation on HTA in Europe

WP1 Lead Partner, in its function as the EUnetHTA Directorate, acknowledges the recent publication of the proposed Regulation on HTA in Europe. The EUnetHTA JA3 Directorate looks forward to constructive dialogue vis-à-vis the proposed Regulation and continues to actively support HTA collaboration in Europe through Joint Action 3.


News and press releases: Management Board started building approval process of EMA premises in Amsterdam

07/02/2018 Management Board started building approval process of EMA premises in Amsterdam Members discussed temporary and permanent premises The European Medicines Agency’s (EMA) Management Board met yesterday in an extraordinary session to discuss EMA’s future premises in Amsterdam. EMA will move from London to Amsterdam before the end of March […]


News and press releases: General Court confirms EMA approach to transparency

06/02/2018 General Court confirms EMA approach to transparency Three rulings clarify the scope of commercial confidentiality with regard to authorised medicines The General Court delivered today three landmark rulings for the European Medicines Agency (EMA), upholding EMA’s decisions to release documents requested in accordance with Regulation (EC) No 1049/2001, the […]


Call for Comments – ATMP guideline on safety and efficacy follow-up and risk management

The revised ATMP guideline on safety and efficacy follow-up and risk management has been released for a 3-month public consultation (deadline of 30th April). EMA would be pleased to receive any HTA comments in respect of the post-authorisation safety and efficacy studies’ endpoints. Please see the links below. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/02/news_detail_002897.jsp&mid=WC0b01ac058004d5c1 Guideline […]


News and press releases: Strengthened guidance on follow-up and risk management for ATMP developers

01/02/2018 Strengthened guidance on follow-up and risk management for ATMP developers Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation The European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management of advanced therapy medicinal […]


News and press releases: Evaluation of advanced therapy medicines

01/02/2018 Evaluation of advanced therapy medicines Updated procedural advice clarifies regulatory process for advanced therapy medicinal products  The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees […]


EU southern alliance on drug pricing expands

Slovenia has joined the “Valletta Declaration”, an alliance of southern EU member states, which aims to explore strategies to jointly negotiate prices with the pharma industry, as well as Croatia with an observer status. In May 2017, the health ministers of Malta, Cyprus, Greece, Italy, Spain, and Portugal signed the “Valletta […]


News and press releases: How to better apply the paediatric legislation to boost development of medicines for children

31/01/2018 How to better apply the paediatric legislation to boost development of medicines for children EMA and European Commission invite stakeholders to register for joint workshop and support development of an action plan The European Medicines Agency (EMA) is inviting expressions of interest in a workshop organised together with the […]


News and press releases: Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation

26/01/2018 Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation Suspension due to serious risks of kidney injury and death in certain patient populations The CMDh[1] has endorsed the recommendation to suspend the marketing authorisations of hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products […]