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November 03, 2020
The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.
An optimal engineering design is crucial for aseptic operation and cleaning.
Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.
November 02, 2020
The agency is balancing a variety of important issues including the review of COVID-19 vaccines.
Industry wants clarification on compliance following the end of the Brexit transition period.
October 30, 2020
The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.
October 15, 2020
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 14, 2020
The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.
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.