Search results for " European Medicines Agency"
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European Medicines Agency
The European Medicines Agency is a decentralized agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical compa…
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GMP Challenges for Advanced Therapy Medicinal Products
Defining manufacturing quality
Senior members of the European Medicines Agency, which is responsible for the EU’s centralized approval procedure, have hinted that different concepts of manufacturin…
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Early Communication with Regulators is Essential for SMEs
Among the EU’s regulatory agencies in pharmaceuticals, the most active in championing innovation has been the European Medicines Agency (EMA), which is responsible for centralized approvals of medicin…
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Ensuring the Quality of Biologicals
As stated in the European Medicines Agency (EMA) Guideline on Similar Biological Medicinal Products (1), “Comparability studies are needed to generate evidence substantiating the similar nature, in te…
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Labeling of Biosimilars
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has reached a key stage in the lengthy process of creating a regulatory framework for the development and…
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EMA Collaborates with HTA Assessment Networks
This approval can be either by the central London-based European Medicines Agency (EMA) for a product to be marketed across the region or by a national licensing authority for one to be sold only in s…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA). The meeting, held in October 2013, wa…
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Biosimilars: Making the Switch Comes with Challenges
These guidelines have been drawn up by the European Medicines Agency (EMA), the London-based EU-wide authority that approves biosimilars.
Market trends
Biosimilar versions of granulocyte-colon…
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Advancing QbD in the EU
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD) concepts over the past 10 years. In 2003, EMA set up a team to back activities in pro…
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Global Expansion Shapes Drug Oversight
At the same time, FDA and the European Medicines Agency (EMA) annouced plans to expand their many collaborative programs, including renewal of a pilot program that allows for parallel review and consu…