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European Union › Risk Assessment › European Medicines Agency (EMA)

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Goodwin

The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

Goodwin on

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

A&O Shearman

European Union to introduce stricter rules on Environmental Risk Assessments for pharmaceuticals

A&O Shearman on

In its proposals to revise the general pharmaceutical legislation (GPL) published this week, the European Union (EU) has recognised that the pharmaceutical product lifecycle can have negative impacts on the environment....more

J.S. Held

Crosscurrents: EU REACH, EMA & Product Stewardship for Sustainability

J.S. Held on

Meta description: Learn more about possible ways to leverage the EU’s REACH and EMA regulations for product stewardship and reaching sustainability goals. Product Stewardship as a Leverage for Sustainability Goals...more

Jones Day

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

Hogan Lovells

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

Hogan Lovells on

In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s...more

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