Search results for "EMA"

Article 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…

Article 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…

Article EMA Confirms Standards for COVID-19 Treatment Evaluations
The European Medicines Agency (EMA) sent an open letter to European Ombudsman Emily O’Reilly, dated Sept. 30, 2020, detailing the agency’s transparency plans for COVID-19 treatments and affirming its …

Article EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
The European Medicines Agency (EMA) has requested that developers determine if their COVID-19 vaccines protect against new virus mutations that have been identified in the United Kingdom, South Africa…

Article EMA Invites Comments on New Guidance for Vaccine Development
…n favor of a broader evaluation of immune responses rather than the use of seroprotection rate and hemagglutination inhibition as the main tests for evaluation; and an introduction of effectiveness s…

Resource EMA scientific guidance documents on biosimilar medicines
This page lists the scientific guidance documents on biosimilar medicines from EMA.

Article 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…

Article 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…

Article EU Sets Guidelines for Biosimilar Monoclonal Antibodies
The London based European Medicines Agency (EMA), which licenses EU pharmaceuticals, has finalized a guideline on biosimilar monoclonal antibodies (mAbs) and is drafting another one on the key issue o…

Article 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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