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August 15, 2022
A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.
August 02, 2022
Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.
Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.
July 25, 2022
A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.
July 02, 2022
A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.
June 27, 2022
The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.
June 21, 2022
The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.
Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.
June 17, 2022
MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.
NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.