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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 15, 2020
The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
October 05, 2020
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.
October 02, 2020
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
October 01, 2020
Symbiosis has successfully completed a scheduled inspection by MHRA.
September 22, 2020
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
September 18, 2020
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
September 15, 2020
GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.
September 10, 2020
Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.