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.

EMA Launched Online Platform for Parallel Distribution

EMA has launched a secure online platform for submitting and managing parallel distribution notifications through the recently implemented IRIS Regulatory & Scientific Information Management Platf...

New Safety Features for EU Medicine

As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) a...

CHMP Accepts Roche’s NSCLC Drug

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Roche's Tecentriq (tezolizumab) - a monoclonal antibody designed to bind with a protei...

EMA Recommended AstraZeneca’s Type I Diabetes Drug

AstraZeneca’s Forxiga (dapagliflozin) has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as an oral adjunct treatment to insulin i...

Sartorius Launches NBE Product Characterization

To provide a range of testing for innovator molecules available either as off-the-shelf assays or custom assay development for more complex proteins. Sartorius Stedim Biotech (SSB) has launched ser...

EMA Set Date for Moving from UK

The European Medicines Agency (EMA) has officially taken over its new building in Amsterdam in preparation of its move to the Dutch capital from London. EMA will leave its premises in London on 1 M...

Non-Compliance Report for Chinese Manufacturer

A Non-Compliance Report has been issued to a Chinese heparin manufacturer after an inspection conducted on October 2018. During this inspection performed by the Italian Health Authority on behalf of E...

Orphan Designation for Silence’s β-Thalassemia Drug

Silence Therapeutics’ lead candidate SLN124 has secured orphan drug designation in the European Union for the treatment of β-Thalassemia. The designation to SLN124 was granted by the Committee for ...

EMA Approved BMS Kidney Cancer Drug

Bristol-Myers Squibb has claimed a new approval for its immuno-oncology combination of Opdivo and Yervoy, getting a green light from the European Medicines Agency (EMA) for its use in renal cell carci...

Paediatric Licence for Asthma Drug

The European Medicines Agency (EMA) has approved Flutiform pMDI for use in the treatment of children with asthma aged five years and over. Flutiform pMDI is a combination of fluticasone propionate ...

84 Positive Opinions from EMA in 2018

EMA has published an overview of its  recommendations of 2018 on the authorisation and safety monitoring of medicines for human use. New medicines are essential for public health as they can improv...

Potential Pitfalls of Brexit for Pharma

With less than 4 months remaining before the UK is scheduled to leave the EU in what is commonly referred to as “Brexit”, concerns are increasing within the pharmaceutical industry about the consequen...

Another Positive CHMP Opinion from EMA for Pfizer

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Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended marketing authorization for Zirabe...

Risk for Pharma after Brexit still Unknown

A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business. Pharmaceutical compa...

EMA released its draft of ‘Regulatory Science to 2025’

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European Medicines Agency has published its draft of strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science.

EMA published new guideline on the environmental risk of human medicines

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The European Medicines Agency (EMA) has published a iconrevision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation.