Search results for " EMA"
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EMA Collaborates with HTA Assessment Networks
The role of these assessments in European national pharmaceutical markets has become so important that EMA has agreed to collaborate with EUnetHTA, a European Union assessment network, on involving HT…
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FDA and EMA Extend QbD Parallel-Assessment Pilot Program
In the joint pilot program, which began in March 2011, FDA and EMA agreed to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pha…
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EMA Confirms Standards for COVID-19 Treatment Evaluations
The agency had suspended its policy to publish clinical data because of EMA’s move from the United Kingdom to the Netherlands, but it is reinstating the policy exclusively for COVID-19 medicines. The …
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EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
Source: EMA
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EMA Invites Comments on New Guidance for Vaccine Development
Source: EMA
Resource
EMA scientific guidance documents on biosimilar medicines
This page lists the scientific guidance documents on biosimilar medicines from EMA.
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Labeling of Biosimilars
Regulatory issues
Nonetheless, there are a number of regulatory issues with biosimilars that parts of the pharmaceutical industry believe still need to be sorted out by EMA. The biggest of these is…
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Early Communication with Regulators is Essential for SMEs
SMEs make up a growing proportion of companies applying to the EMA for an initial evaluation of a new medicine, including its manufacturing process. Almost 30% of applicants in 2012 were SMEs, which a…
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Advancing QbD in the EU
In 2003, EMA set up a team to back activities in process analytical technology (PAT) in the EU. The agency has seen its PAT team as a key element in the implementation of QbD by encouraging process un…
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Biosimilars: Making the Switch Comes with Challenges
Biosimilar infliximab, the first biosimilar monoclonal antibody (mAb) to be approved by EMA in 2013, has had an uptake varying from approximately 10-50% in the five leading EU markets of France, Germa…