All Clinical Trials articles
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JournalNavigating the Australian Office of the Gene Technology Regulator: A regulatory affairs perspective on clinical trials involving genetically modified organisms
This article provides a background to the OGTR’s role in overseeing the use of GMOs in clinical trials, the licence application process, different types of licences and conditions associated with each.
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Industry newsFDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
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Industry newsFAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act
The first results from the Facilitating and Accelerating Strategic Clinical Trials in the EU (FAST-EU) Pilot programme have been published by the Heads of Medicine Agency (HMA). Initial results indicate strong interest and engagement from stakeholders and the possibility of a 70-calendar-day approval timeline for clinical trial ...
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Industry newsFDA launches Operation TrialBlazer to accelerate US clinical research
The US Food and Drug Administration (FDA) has announced plans to revitalise clinical research in the USA, as part of a US Department of Health and Human Services (HHS) initiative titled ‘Operation TrialBlazer’. The FDA has proposed multiple actions to achieve this aim, targeting both early- and late-stage ...
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Industry newsACT EU issues draft guidance on clinical trials during emergencies
Accelerating Clinical Trials in the EU (ACT EU) has issued new draft guidance that outlines clinical trial conduct during public health emergencies (PHEs). Public consultation is open until 30 April 2026.
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Industry newsMHRA points to clinical trial growth and faster assessment routes
This industry news update shares how clinical trials have grown over the past year and new regulations coming into effect.
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JournalHM10: Strengthening Europe’s clinical trials competitiveness
This is a report of the HM10 session that took place at this year’s Symposium.
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JournalHM2: Fireside chat
This is a report of the HM2 session that took place at this year’s Symposium.
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Industry newsMHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
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JournalDiversity in clinical research: Regulatory considerations and updates
This article explores how to improve diversity and patient representation in clinical trials and looks at guidance from the EMA.
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ContentsJuly/August 2025 – Contents
The July/August issue of Regulatory Rapporteur focuses on patient involvement.
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EditorialPatient voice: Shaping the future of medicine regulation
This issue looks at the evolving landscape of public and patient involvement (PPI) and how the views of the patient community are being included in research, academia, health and social care and regulatory decision-making.
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Industry newsFDA to replace animal testing with new approach methodologies
The US Food and Drug Administration (FDA) has announced plans to replace animal testing for monoclonal antibodies (MABs).
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JournalRegulatory governance for medical research in the United Arab Emirates: A comprehensive overview
Since the country’s establishment in 1971, the United Arab Emirates (UAE) has strived for the continual progress and prosperity of the country and its people. This is reflected in the constantly improving research regulatory governance framework that encompasses both federal and local requirements. This article provides a comprehensive overview of the UAE’s research governance structure and highlights its requirements and applicable legislation, both at federal and local levels.
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JournalClinical research in Africa: Regulatory environment, challenges and opportunities
Africa is a destination for clinical research and its developments and growing potential should not be overlooked. There are benefits for those who intend to gain an understanding of the challenges and opportunities on this large and varied continent. Although the diversity of the people, cultures and regulations in Africa has an impact on complexity, there are numerous regulatory and harmonising organisations working to improve efficiencies, many of which require meticulous collaboration.
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Industry newsMHRA approves Nemolizumab for eczema patients in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nemolizumab, also known as Nemluvio, to help with the treatment of atopic dermatitis (eczema) in the UK.
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Industry newsFDA programme set to improve diversity in clinical trials
The US FDA’s Oncology Center of Excellence has launched an initiative to improve access to clinical trials for under-represented populations.
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Industry newsMelanoma vaccine enters Phase III clinical trials
A personalised mRNA vaccine for a deadly form of skin cancer is being rolled out in an international Phase III clinical trial.
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Industry newsParkinson’s drug slows progression of motor symptoms
A developmental drug has shown promise in slowing symptoms of motor deterioration in people with advanced forms of Parkinson’s.