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.

Sales of veterinary antimicrobials in Europe decreased by about 20%

veterinary-antibiotics
A new report published by European Medicines Agency (EMA) shows that the overall sales of veterinary antimicrobials across Europe have decreased by more than 20% between 2011 and 2016.

EU authorities continue investigating sartan medicines

counterfeit drug
EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management.

EMA published update on Brexit preparedness

european medicines agency
The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018, as announced at the beginning of August 2018.

Paratek Pharmaceuticals seeks EMA approval for its novel antibiotic

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Paratek Pharmaceuticals (USA) announced the acceptance of the submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for omadacycline.

European Commission released action plan on paediatrics

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The European Medicines Agency and the European Commission’s Directorate-General for Health and Food Safety have published a joint action plan to support the development of medicines for children.

EMA launches a new version of its website

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The European Medicines Agency (EMA) has launched a new version of its corporate website. The website has a number of new features to improve user experience.

EMA and European Commission published new information on biosimilars

biosimilars
The European Medicines Agency and the European Commission have published material on biosimilar medicines, as part of their collaboration to improve understanding of biosimilars.

Chinese API manufacturer refused admittance to EU inspection

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European medicines regulators have issued a notice that an ingredient for a generic brain cancer drug made in China does not meet manufacturing standards, after inspectors were refused entry.

EU regulators published their work programme for 2019/20

European-Commission
The task force set up by European Union (EU) regulators to better address potential problems with medicines’ supply and to avoid shortages published its work programme for the coming two years.

UK will accept EU-based batch testing of medicines

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European pharmaceutical companies will be able to supply their medicines in the UK on the basis of approved batch testing carried out in the EU for at least two years.

EMA and FDA will conduct workshop on PRIME and Breakthrough Therapy schemes

eu-us
EMA and FDA launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible.

European Commission approved Novartis migraine drug

novartis
Novartis announced that the European Commission (EC) approved Aimovig® (erenumab) for the prevention of migraine in adults experiencing four or more migraine days per month.

EU and Japan strenghten collaboration on inspections of drug manufacturers

drugs
The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites.

British Parliament voted to keep UK in EMA after Brexit

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On July 17, The UK Parliament voted 305-301 in favor of continuing the UK’s involvement with the European Medicines Agency (EMA) after the island leaves the EU.

EMA published the first report on its transparency policy

clinical trials
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).

EMA survey displayed gaps in pharma industry preparedness for Brexit

european medicines agency
Regulatory authorities and marketing authorisation holders both play an important part in preparing for the consequences of Brexit to safeguard the continuous supply of medicines after the withdrawal of the UK from EU.