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DSRU plans ‘post-authorisation’ study of COVID-19 vaccines in the UK
pharmatimes
December 04, 2020
The Drug Safety Research Unit – an independent academic unit based in Southampton, UK – is planning to conduct an active surveillance study on COVID-19 vaccine following regulatory authorisation.
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Evaluating Pfizer vaccine for possible listing for emergency use: WHO
expresspharma
December 03, 2020
WHO is in discussions with MHRA for accessing some of information from their assessment which may expedite WHO’s emergency listing.
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MHRA starts rolling review of AZ’s coronavirus vaccine
pharmatimes
November 06, 2020
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has started an accelerated or rolling review of AstraZeneca’s coronavirus vaccine candidate, the British pharma giant confirmed on Sunday.
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UK regulator initiates rolling review of AstraZeneca’s vaccine for Covid-19
pharmaceutical-technology
November 04, 2020
UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has initiated the accelerated rolling review of AstraZeneca’s potential vaccine to treat Covid-19.
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MHRA allows HAE patients early access to berotralstat
pharmatimes
November 04, 2020
Patients with hereditary angioedema (HAE) living in the UK will get early access to BioCryst's berotralstat before the drug is officially approved for this indication by the European Commission.
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UK MHRA commences accelerated review for AstraZeneca’s COVID-19 vaccine candidate
expresspharma
November 02, 2020
In rolling reviews, regulators can see clinical data in real-time and have discussions with pharma companies on manufacturing processes and trials to accelerate the approval process.
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UK’s MHRA starts rolling review of Moderna’s COVID-19 vaccine
pharmatimes
October 29, 2020
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has begun the rolling review process of Moderna’s COVID-19 vaccine candidate, mRNA-1273.
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MHRA joins international regulatory consortium
europeanpharmaceuticalreview
October 22, 2020
By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
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Symbiosis Completes MHRA Regulatory Inspection
contractpharma
October 15, 2020
Scottish CMO recorded no critical or major observations from the reinspection by the MHRA.
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Clinical trials of AstraZeneca-Oxford COVID-19 vaccine candidate resumes in UK
expresspharma
September 24, 2020
This is following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.