All EMA articles
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Industry news
Contraindication for mixing weight loss medicine Mysimba with opioids
The European Medicines Agency (EMA) published new advice in July 2024 concerning the combined use of opioid medications and the weight loss drug Mysimba (naltrexone/bupropion).
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Journal
Artificial 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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Video
European 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 news
Stakeholder 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The EMA has published draft guidance − ICH E6 (R3) − on good clinical practice for clinical trials, which is open for public consultation.
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Journal
A 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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Interview
Every 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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Journal
HM3: 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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Journal
The 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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Journal
EU 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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Journal
The 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 Supplement
The 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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Journal
Updates 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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Journal
A 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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Focus
Gene 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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Journal
A 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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Journal
Navigating 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 Report
The 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 Report
MD5: 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 Report
HM4: 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.