News & Analysis as of

Life Sciences Medicines and Healthcare Products Regulatory Agency (MHRA) Prescription Drugs

Hogan Lovells

JPM2025: AI integration into UK’s MHRA’s processes presents opportunities, and challenges for regulating medicinal product...

Hogan Lovells on

Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McDermott Will & Emery

Lowest-risk Clinical Trials Will Benefit From a New Notification Scheme and a Shorter Period for Application Processing

McDermott Will & Emery on

On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

European Biosimilar Regulatory Updates

Goodwin on

STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK - On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory...more

Hogan Lovells

New UK Medicines and Medical Devices Bill Announced

Hogan Lovells on

The Queen's Speech, which set out the government's proposed plan for new legislation, included a new "Medicines and Medical Devices Bill". The government's background briefing describes the purpose of the Bill as ensuring...more

Hogan Lovells

New UK MHRA No Deal Guidance

Hogan Lovells on

With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more

Hogan Lovells

Updated UK “no deal” Brexit guidance on medicines, medical devices and clinical trials

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more

Hogan Lovells

UK MHRA consults on no-deal Brexit legislation

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more

Hogan Lovells

UK publishes paper on Brexit and medicines regulation

Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

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