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Medicines and Healthcare products Regulatory Agency

This page shows the latest Medicines and Healthcare products Regulatory Agency news and features for those working in and with pharma, biotech and healthcare.

AstraZeneca’s mild combination asthma reliever approved in UK

AstraZeneca’s mild combination asthma reliever approved in UK

Asthma is a chronic, variable, inflammatory disease characterised by asthma attacks and symptoms including breathlessness and wheezing. ... The Medicines and Healthcare products Regulatory Agency's (MHRA's) decision on Symbicort, which is already

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  • Rare diseases: not so rare after all Rare diseases: not so rare after all

    Incentive offers from regulators such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) to address unmet medical needs. ... The development of rare disease

  • The future of medtech is in the past The future of medtech is in the past

    Siren voices within the sector fear that this regulatory burden alone may threaten the resilience of manufacturers and their products, particularly SMEs that make up 95% of the medtech market. ... An approved notified body is an organisation designated

  • Integrating electronic health records into clinical trials Integrating electronic health records into clinical trials

    In other scenarios, data captured in routine healthcare and stored in EHRs could enable researchers to show how drugs work in the real world, identify populations with unmet needs and inform ... The UK Medicines and Healthcare products Regulatory Agency

  • The evolution of real-world studies The evolution of real-world studies

    The European Medicines Agency has shown a willingness to consider data from outside RCTs, noting in 2018 guidance on factor VIII products that changes to the patient population have made it ... The UK has high hopes for the study, which the Medicines

  • Brexit implications for UK pharma legislation Brexit implications for UK pharma legislation

    For pharmaceuticals, it will be impossible to simply ‘copy and paste’ EU medicines law into UK law because EU law so heavily references the European Medicines Agency (EMA) and a ... Given that the UK’s medicines agency, the Medicines and Healthcare

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Latest appointments

  • greyhealth group appoints digital strategy director greyhealth group appoints digital strategy director

    He joins from Virgo Health, where he served as head of digital across its healthcare communications, medical education and consumer health and wellbeing divisions. ... Previously, he was digital team lead for Care UK, a health and social care service

  • Dr June Raine continues as chair of EMA's pharmacovigilance committee 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 ... Health Products Regulatory Authority.

  • MHRA names vice-chair of Commission on Human Medicines MHRA names vice-chair of Commission on Human Medicines

    Dr Thomas replaces Prof Ian Weller who retires from the body, which advises the Medicines and Healthcare products Regulatory Agency (MHRA) on drug safety and efficacy. ... The Commission plays a vital role in the licensing of new medicines and in

  • Former NICE chair Sir Michael Rawlins to lead MHRA Former NICE chair Sir Michael Rawlins to lead MHRA

    He will take up his new role at the UK's medicines and devices regulator in December. ... The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has named UK healthcare veteran Sir Michael Rawlins as its new chair.

  • MHRA appoints director of licensing MHRA appoints director of licensing

    Siu Ping Lam assumes role on permanent basis. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has appointed a new director of licensing. ... His extensive expertise and experience will be vital in our role of safeguarding public

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Genesis Research

Genesis Research is an international HEOR and RWE research organization. A leader in evidence strategy, generation and communication, the company...

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Virtual Patient Engagement Program: A Customer Story
Our client wanted to better understand the needs, preferences, and treatment gaps among adult patients with a rare genetic disease......
Humancomms for humancare?
Paul Hutchings, founder of fox&cat, writes on the role of humour in healthcare comms: PharmaComms 2023...
Rare diseases: not so rare after all
The brave new world addressing rare diseases – a way ahead to better and more inclusive treatment...