European Medicines Agency

The European Medicines Agency (EMA) was introduced in 1995, and is a decentralised agency of the European Union (EU), located in London. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.


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 […]


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018

20/07/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018 CVMP adopts revised guidance on assessment of the risk to public health from resistance due to use of antimicrobials in food-producing animals CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion […]


News and press releases: EU and Japan reinforce their collaboration on inspections of medicine manufacturers

18/07/2018 EU and Japan reinforce their collaboration on inspections of medicine manufacturers Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each […]


News and press releases: Update on review of valsartan medicines following detection of impurity in active substance

17/07/2018 Update on review of valsartan medicines following detection of impurity in active substance Assessing potential impact on patients is priority EMA’s review of valsartan medicines in relation to an impurity found in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals is now underway. The impurity – N-nitrosodimethylamine (NDMA) […]


News and press releases: EMA’s proactive publication of clinical data a success

16/07/2018 EMA’s proactive publication of clinical data a success First report on unprecedented transparency policy shows high user satisfaction The European Medicines Agency (EMA) has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070). Under this policy citizens, including researchers […]


News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018

13/07/2018 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018 PRAC recommends restricting use of prostate cancer medicine Xofigo Following a review of data showing a possible risk of earlier death and an increase in fractures with Xofigo (radium-223 dichloride), the European Medicines Agency’s (EMA) Pharmacovigilance Risk […]


News and press releases: EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) elects new Chair

11/07/2018 EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) elects new Chair Sabine Straus from the Netherlands to begin three-year mandate from 3 September 2018 At its July 2018 meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) elected Sabine Straus from the Netherlands as its new Chair, for a three-year […]