Search results for " EMA" in Articles / App Notes
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
The meeting, held in October 2013, was called to consider issues raised by three of EMA’s revised guidelines on biosimilars, one covering general principles, the second on non-clinical and clinical ma…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Ensuring the Quality of Biologicals
This new approach is aligned with the development approach for biosimilars and involves communication channels between the main regulatory players in Europe: EMA, national authorities, and the Europea…
Article
The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…
Article
Global Expansion Shapes Drug Oversight
At a London meeting in April, senior leadership from FDA, EMA, and the European Commission reviewed efforts to leverage each other’s inspection resources; collaboration to support global development o…
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Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
GMP Challenges for Advanced Therapy Medicinal Products
“ATMPs are complex pharmaceuticals, for which traditional approaches may not be possible,” Paula Salmikangas, chair of the EMA’s committee for advanced therapies (CAT), told an European Directorate fo…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
More complexity equals more development challenges
Compared to the relatively small protein-based drugs for which biosimilars have been approved by EMA, such as epoetins, filgrastims, growth hor…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…