Tag: EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.
EMA serves a market of over 500 million people living in the EU.

Regulatory Science Strategy to 2025 in the EU

EMA has published its Regulatory Science Strategy to 2025. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It come...

EMA: Chloroquine only to Be Used in Clinical Trials or Emergency Use Programmes

clinical-trials
Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated worldwide for their potential to treat coronavirus disease (C...

Update EMA on Treatments and Vaccines against COVID-19 under Development

vaccines
EMA’s COVID-19 response team has been in contact with developers of around 40 therapeutic medicines, allowing better understanding of potential treatments. However, at this point, on the basis of the ...

EMA Warns about Falsified Drugs from Unregistered Websites

The European Medicines Agency (EMA) is urging the public not to buy medicines from unauthorised online pharmacy websites and vendors. They state that any claim a product can treat or prevent COVID-19 ...

Use of Medicines for Hypertension, Heart Disease During COVID-19 Pandemic

EMA is aware of recent media reports and publications which question whether some medicines, for instance angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sar...

Restrictions on the Use of the Antibiotic Fosfomycin

EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicin...

EMA Has Recommended New Gene Therapy to Treat SMA

EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscul...

New Guidance: Clinical Trials During the COVID-19 Pandemic

clinical-trial-material
The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical tria...

EMA Informs on the Use of Non-steroidal Anti-inflammatories for COVID-19

There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19, said EMA. In May 2019, EMA’s safety committee (PRAC) started a review of the non-steroidal...

Recommended Women to Stop Taking Ulipristal Acetate for Uterine Fibroids

EMA’s safety committee (PRAC) has recommended women to stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids while a safety review is ongoing. No new patients should s...

PRAC Starts Review of Certain Ifosfamide Cancer Medicines

At its monthly meeting, EMA’s safety committee (PRAC) has started a review of medicines containing ifosfamide to examine whether there is a higher risk of encephalopathy (brain disorder) with ifosfami...

EMA Can Give Developers Prompt Guidance on the Best Methods to Generate Drugs for COVID-19

EMA provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat the disease) or vaccines (to prevent the disease) against the novel coronavirus dis...

COVID-19: EMA’s Plans Are Being Continually Reviewed

As a precautionary measure, all meetings of EMA committees and working parties will be held virtually until the end of April 2020. In addition, stakeholder events hosted by EMA which were planned to t...

EMA Announces Update on Nitrosamines in EU Medicines

EU and national authorities are continuing their work to prevent and manage the presence of nitrosamine impurities in EU medicines. Nitrosamines are classified as probable human carcinogens (substa...

EMA Has Implemented Changes to its Organisational Structure

The purpose of the re-organisation is to ensure that the Agency operates as efficiently as possible to deliver high quality outputs for public and animal health. The exercise takes into account the ra...

Two New Medicines Recommended CHMP for Approval

EMA’s human medicines committee (CHMP) recommended two medicines for approval at its February 2020 meeting. The Committee recommended granting a marketing authorisation for Fetcroja (cefiderocol) f...