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MHRA
This page shows the latest MHRA news and features for those working in and with pharma, biotech and healthcare.
UK announces new ten-year Life Sciences Vision to support life sciences sector
In particular, the UK is looking to replicate the successes of its Vaccines Taskforce, while also utilising the Medicines and Healthcare products Regulatory Agency’s ( MHRA) new position as an independent
Latest news
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MHRA outlines two-year delivery plan with ‘patient first’ focus
The delivery of these plans is underpinned by the creation of a new business model that will provide a ‘financially sustainable future’ for the MHRA. ... life sciences industry and to healthcare,” said June Raine, chief executive of the MHRA.
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MHRA grants bluebird bio’s LentiGlobin gene therapy an ‘innovation passport’
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted bluebird bio’s potential sickle cell disease gene therapy a new ‘innovation passport’. ... The designation clearly shows that the MHRA understands the value and enormous
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Global consortium of medicines regulators reveals new strategic plan
Initially, the group consisted of regulatory authorities from Australia, Canada, Singapore and Switzerland, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) joining in October 2020. ... The MHRA is also part of another group of
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J&J's single-dose COVID-19 vaccine secures approval from the UK’s MHRA
Johnson &Johnson’s (J&J) single-dose COVID-19 vaccine has secured authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the regulator announced today.
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EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15
A spokesman for Pfizer previously confirmed that the company has submitted data for the vaccine in 12- to 15-year-olds to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
MHRA outlines two-year delivery plan with ‘patient first’ focus
MHRA grants bluebird bio’s LentiGlobin gene therapy an ‘innovation passport’
Global consortium of medicines regulators reveals new strategic plan
J&J's single-dose COVID-19 vaccine secures approval from the UK’s MHRA
EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15
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Approximately 45 fully matching, plus 264 partially matching documents found.
Latest Intelligence
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How early-stage clinical research is facilitating the new wave of personalised medicines
The MHRA has also adapted its processes to support the rapid development and uptake of precision therapies. ... The MHRA has shown a willingness to understand the unique nature of gene therapy studies and they have shown flexibility and speed when
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Patient diversity in clinical trials needs to be centre stage
Regulatory pressure, particularly from the FDA and more recently by the MHRA and EMA, is encouraging inclusivity and diversity, she added.
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Setting up for success in a post-Brexit, post-pandemic Britain
What is most important to understand about Brexit is the fact that it is totally new to all of us, even the MHRA. ... as new to the MHRA as it is to us and requirements are being updated weekly.
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A new era for UK-Japanese scientific research relations
The MHRA meets the standards of the EMA, PDMA and FDA, but it also encourages innovation through its openness, advice and support services for partners. ... Lastly, to international audiences, we need to continue to highlight the leading work of the MHRA
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A cultural shift in clinical research
Since 2018, the MHRA has allowed the use of electronic methods for seeking, confirming and documenting informed consent for participation in research.
How early-stage clinical research is facilitating the new wave of personalised medicines
Patient diversity in clinical trials needs to be centre stage
Setting up for success in a post-Brexit, post-pandemic Britain
A new era for UK-Japanese scientific research relations
A cultural shift in clinical research
More from intelligence
Approximately 2 fully matching, plus 29 partially matching documents found.
Latest appointments
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NDA Group appoints Alison McGregor as its principal consultant
She has over 20 years’ experience in the pharmaceutical sector working for both industry and regulatory agencies including AstraZeneca and the UK’s MHRA.
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PharmaLex appoints Zabin Younes as associate director
In addition she also has over ten years of management experience and has set up and managed research teams, GMP testing laboratories and led MHRA/FDA corporate audits.
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Dr Gopalan Narayanan joins VCLS
With a focus on advanced therapies and other biologics, he was at UK medicines regulator the MHRA for nearly 12 years as an expert medical assessor and during that time spent
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Dr June Raine continues as chair of EMA's pharmacovigilance committee
Dr Raine is director of vigilance and risk management of medicines at the Medicines and Healthcare products Regulatory Agency (MHRA) and has served as PRAC chair since it was set up
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New health ministers and re-appointments after reshuffle
Freeman's role is also tied into the Department for Business, Innovation and Skills and includes expanded responsibility for the Cancer Drugs Fund, NICE and MHRA, research and development, issues around
NDA Group appoints Alison McGregor as its principal consultant
Dr June Raine continues as chair of EMA's pharmacovigilance committee
New health ministers and re-appointments after reshuffle
More from appointments
Approximately 11 fully matching, plus 7 partially matching documents found.
Latest from PMHub
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Key barriers to effective patient engagement in pharma, and how to fix them: Making engagement processes more patient friendly
Working with regulatory bodies to enable easier collaboration while maintaining patient safety. Both the ABPI and MHRA in the UK are demonstrating how they value patient engagement by launching their own
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Is COVID-19 yet another barrier to contraceptive access?
So far, one of the biggest moves made to combat this issue was the approval of two over-the-counter contraceptive pills by the MHRA.
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WHITE PAPER: From bench to bedside in one year - how the race for a COVID-19 vaccine will change the future of drug development
example, the Medicines and Healthcare Products Regulatory Agency (MHRA) have invested in efforts to use artificial intelligence (AI) in order to improve the process of reporting adverse events, which hopefully could
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How does the government plan to reshape the NHS?
Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) would develop and maintain publicly funded and operated medicines registries, and work with the NHS to populate and maintain them ... Currently, the MHRA receives data from
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The UK has approved the first vaccine for COVID-19. What now?
The authorisation of Pfizer/BioNtech's mRNA vaccine by the MHRA is great news, but no-one has ever tried to roll out a vaccine as rapidly as this one, so
Key barriers to effective patient engagement in pharma, and how to fix them: Making engagement processes more patient friendly
Is COVID-19 yet another barrier to contraceptive access?
WHITE PAPER: From bench to bedside in one year - how the race for a COVID-19 vaccine will change the future of drug development
More from PMHub
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