All EMA articles
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JournalArtificial intelligence in drug discovery
Regulatory Rapporteur January 2024 | Volume 21 | No.1 Introduction The recent publication of papers by the European Medicines Agency (EMA)[1] and the Food and Drug Administration (FDA)[2][3] has spurred the debate on ...
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VideoEuropean Parliament gives first stage approval for revised EMA fees
MEPs in Strasbourg follow the parliament’s health committee’s approval of report to revise how EMA charges.
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Industry newsStakeholder feedback sought on EMA draft clinical guidelines
The EMA has published draft guidance − ICH E6 (R3) − on good clinical practice for clinical trials, which is open for public consultation.
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JournalA critical review and comparison of the processes when seeking scientific advice in the EU and the USA – Part 1
GRAY, MSc − PART ONE OF A TWO-PART SERIES(See part 2 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory Agencies such as EMA and FDA regard provision of SA as a core ...
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InterviewEvery patient has a story to tell us
Dr Francesco Pignatti, Head of Oncology and Haematology at the EMA, discusses his career, his inspirations, and why it is important to involve patients in regulatory decisions.
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JournalHM3: Lessons learned and strategic priorities
The profession needs to adapt to the power of technology and the widespread dissemination of misinformation on social media is causing real-world harm.
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JournalThe power of collaboration
Katherine Tyner, FDA Liaison to the EMA, Office of Global Policy and Strategy, FDA, discusses her position as a primary point of contact between the world’s two most important Agencies, and the goals they share for the future of public health.
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JournalEU expert panels for high-risk devices - another level of review?
The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both ...
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JournalThe new UK MDR - a great start to a long road ahead
On 29 March 2017, the UK invoked Article 50 of the Treaty on European Union (EU)[1] and began the withdrawal process from the EU. Despite the UK’s departure from the EU on 31 January 2020, EU legislation continues to apply in UK domestic law. This means that, for the medical ...
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CPD SupplementThe Olaratumab experience
As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...
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JournalUpdates to quality legislation from the EMA
Brian Dooley, Quality Specialist in the Pharmaceutical Quality Office of the EMA, discusses his role, new marketing applications and updates to quality legislation.
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JournalA regulatory view on the change management process for medicinal products
An effective change control process is a critical part of good manufacturing practice (GMP), during the post-approval phase of a medicinal product’s lifecycle. This article reviews key aspects of the current EU and International Conference on Harmonisation (ICH) quality guidelines. The operational aspects of the change control process are explored and guidance is provided on how the strategic review of changes can avoid or minimise the regulatory impact.
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FocusGene therapy products: regulatory expectations and challenges for industry
As the technology behind gene therapy products continues to evolve, applicants face the challenge of adapting their programmes to increasingly demanding and detailed regulation. This article provides an overview of current regulatory expectations and the challenges they may present to industry.
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JournalA review of paediatric development challenges, FDA collaboration and future trends
Susan McCune M.D. Susan McCune M.D., is a paediatrician and neonatologist, with 18 years’ academic clinical and research experience. This was followed by 18 years at the US FDA where, from 2017 to 2021, she was the director of the Office of Pediatric Therapeutics in the Office ...
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JournalNavigating the regulatory landscape for regenerative medicines in Japan
This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines…[1],[2]
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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 1)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1 and 2 June 2021 as a virtual event with over 500 participants globally connected.
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Meeting ReportMD5: Innovation in Drug-Device Combinations
The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…
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Meeting ReportHM4: Real world evidence in regulatory decision-making
During the first part of the session, Fred Senatore discussed applications and the challenges of real word data (RWD) and real-world evidence (RWE). He opened his talk with a definition of the two, with RWD being defined as the data collected from a variety of sources, and RWE as the analysis of the source.
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CPD SupplementDigital health technologies – an overview of EU and US frameworks
Digital health technologies have revolutionised the global healthcare system. This continuing professional development supplement provides an overview of the qualification frameworks for digital health technologies, which are used as drug development tools in the EU and the US.
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CPD SupplementUnderstanding the basics of ATMP regulation
Advanced therapy medicinal products (ATMPs) are biological products which comprise a diverse group of medicinal products that are often complex and diverse in nature. As these products are regularly developed for diseases of high unmet need, the requirements for evidence generation to support marketing authorisation often require innovative development plans. Within this continuing professional development supplement we investigate the regulation of ATMPs in the EU and US [see also Regulatory Rapporteur October 2020 and February 2020 for articles by Harriet Edwards on ATMPs].