This page shows the latest MHRA news and features for those working in and with pharma, biotech and healthcare.
The announcement follows a public consultation carried out by the MHRA, in which respondents highlighted the urgent need to establish a regulatory framework for POC products. ... The MHRA said it will also begin to develop guidance, together with
Brukinsa was most recently granted two new marketing authorisations by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of CLL, as well as for patients with marginal zone ... The MHRA authorisation for MZL – a group of
BeiGene’s Brukinsa (zanubrutinib) has been granted two new marketing authorisations by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of chronic lymphocytic leukaemia (CLL) and for patients ... The MHRA’s decision on
once again confirm the favourable safety and tolerability profile of VLA2001, which was important for European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) approval.”.
The Medicines and Healthcare products Regulatory Agency (MHRA) has received a total of £970, 688 from the Department for Business, Energy and Industrial Strategy’s (BEIS) Regulators’ Pioneer Fund. ... One of the MHRA’s central aims is to focus on
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved to the extend the terms of the marketing authorisation for LEO Pharma’s Adtralza (tralokinumab) to include the treatment of adolescent
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The UK, and the worldwide, clinical trials industry was already complying with most of the GDPR requirements due to strict regulatory requirements (including the FDA, MHRA, PMDA, ICH, GCP, etc) before ... Looking ahead, advances in clinical protocol
An approved notified body is an organisation designated by the Medicines and Healthcare products Regulatory Agency (MHRA) to assess whether manufacturers and their devices meet the requirements set out in the
the MHRA, and welcome the shift they are initiating towards a more streamlined, combined review. ... Beyond the MHRA, regulatory agencies across the world have also recognised the importance of innovations in trial design.
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
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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She has over 20 years’ experience in the pharmaceutical sector working for both industry and regulatory agencies including AstraZeneca and the UK’s MHRA.
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.
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
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
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
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There’s also the regulatory side of things too. A number of the leading regulatory bodies in the world now, including the FDA in the US and the MHRA in the
Published December 23, 2021. Accessed March 29, 2022. Lucy Parsons. MHRA approves over-the-counter contraceptive pill.
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
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.
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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Streaming Well is a healthcare-focused, award-winning video production company which operates in the US and Europe. We create engaging visual...