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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 01, 2021
FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.
September 24, 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.
January 01, 2017
How involved should HTA bodies be in assessing cost effectiveness and reimbursements?
June 01, 2016
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
December 01, 2015
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
July 01, 2015
The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.
February 01, 2015
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
January 01, 2015
The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.
September 01, 2014
As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
May 02, 2014
The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.