Search results for "EMA" in Articles / App Notes
Article
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…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
In a US National Institutes of Health study, lead investigator Rebecca Sheets, PhD, systematically characterized the breadth and sensitivity of routine in-vitroand in-vivoassays for inapparent viruses…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
EMA, Guideline on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products (London, May 30, 2013).
2. EMA, Requirements and Controls Applied to Bovine Serum Us…
Article
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…
Article
The Bullish Outlook for Biosimilars
Yet questions and uncertainties remain, and the path forward likely holds some surprises.
Update on the Global Biosimilar Market
The magnitude of the biosimilar market’s true potential can…
Article
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…
Article
Design and Qualification of Single-Use Systems
International Council for Harmonization (ICH) Q7, European Medicines Agency (EMA) Q7, and FDA
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients incorporate essentially…
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…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The European Medicines Agency (EMA) approved the first mAb biosimilar developed by Celltrion and Hospira in 2013 (infliximab: Remsima/Inflectra). Development of clear, regulatory approval pathways for…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
Three products are indicated against cancer and a further two against genetic diseases, while the remainder target a wide range of medical conditions.
In terms of expression systems use…