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: Update on medicines containing valsartan from Zhejiang Tianyu

20/08/2018 Update on medicines containing valsartan from Zhejiang Tianyu Company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA The company Zhejiang Tianyu is no longer authorised to manufacture the valsartan active substance for EU medicines following the suspension of its CEP – […]


News and press releases: Update on review of recalled valsartan medicines

02/08/2018 Update on review of recalled valsartan medicines Preliminary assessment of possible risk to patients EMA is conducting a review of the possible health effects in patients who may have taken valsartan medicines containing N-nitrosodimethylamine (NDMA) – an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals. NDMA […]


News and press releases: Brexit preparedness: EMA to further temporarily scale back and suspend activities

01/08/2018 Brexit preparedness: EMA to further temporarily scale back and suspend activities The European Medicines Agency (EMA) will launch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while […]


News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

27/07/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018 Sixteen medicines recommended for approval, including two orphans The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval, including two orphan medicines1, at its July 2018 […]


News and press releases: New medicine for hereditary rare disease

27/07/2018 New medicine for hereditary rare disease Onpattro addresses unmet medical need for treatment of hereditary transthyretin amyloidosis The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Onpattro (patisiran), for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in […]


News and press releases: Two new paediatric-use marketing authorisations recommended by CHMP

27/07/2018 Two new paediatric-use marketing authorisations recommended by CHMP Kigabeq and Slenyto developed specifically for children based on existing medicines The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use(CHMP) has recommended granting two new paediatric-use marketing authorisations (PUMAs), for Kigabeq (vigabatrin) and Slenyto (melatonin). PUMAs can be […]