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April 11, 2019
The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.
April 05, 2019
From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.
April 03, 2019
In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.
April 02, 2019
Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.
April 01, 2019
The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.
Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.
March 29, 2019
ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.
March 26, 2019
The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.
March 08, 2019
The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019.
Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.