All Journal articles – Page 3
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JournalA key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation
Regulatory Rapporteur June 2024 | Volume 21 | No.6 Abstract The need for early collaboration between regulators and European Union’s (EU) Health Technology Assessment (HTA) bodies when developing ‘fit-for-purpose’ evidence generation plans has long been acknowledged, and the ...
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JournalOver two years into the new veterinary medicines rules for the EU: a reflection on where we are now
The European Union’s Veterinary Medicines Regulation became law on 27 January 2019 and brought many changes, some of which were highly significant
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JournalProject Orbis – a sponsor’s perspective on the collaborative international review process
Project Orbis provides a framework for concurrent submission and review of regulatory dossiers with member agencies in the project, and has the goal of providing faster patient access to innovative cancer therapies
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JournalComparing China Drug Master Files with the EU and US
This is the third article in a six-part series that will focus on the regulations in China’s drug market. There will be different topics each month with the initial focus on the drug master file (DMF) filing process followed by the drug registration process and pharmacovigilance requirements.
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JournalThe availability of medicines post-Brexit in Malta
Malta has historically sourced medicinal supplies from the UK, but following Brexit insufficient supply of medicines represents a significant obstacle to patients’ access to medicines.
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JournalThe UK Responsible Person Association
The UK Responsible Person Association was established soon after the implementation of Brexit to represent and promote the newly created profession of UK Responsible Person
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JournalOpportunities and challenges in the Latin American pharmaceutical industry
Despite competition from both local and international players, the Latin American pharmaceutical market has experienced a steady growth in recent years
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JournalThe European Association of Authorised Representatives
This is the first instalment in a three-part series examining the statutory functions with respect to medical devices and in vitro diagnostics that flowed from the enactment of the European Union’s (EU) Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) and ...
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JournalThe first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
Regulatory Rapporteur May 2024 | Volume 21 | No.5 Abstract Patients with transfusion-dependent β-thalassemia and severe sickle cell disease suffer the burden of repeated blood transfusions and vaso-occlusive crises, respectively. Casgevy (exagamglogene autotemcel) consists of autologous CD34+ haematopoietic stem ...
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JournalMedical device standards update: March 2024
This edition of our regular column updates the progress of applicable standards to March 2024
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JournalNavigating the process complexities and challenges associated with EU-CTR transition applications
Regulatory Rapporteur May 2024 | Volume 21 | No.5 Abstract From 31 January 2025, clinical trials authorised under the old EU Clinical Trial Directive (CTD) must either have ended in the EU/EEA or have been transitioned to new EU ...
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JournalChoosing the right registration pathway for the China drug master file: an essential analysis of options
Regulatory Rapporteur April 2024 | Volume 21 | No.4 Abstract Building upon the foundational insights presented in the first article of our China series, this subsequent piece delves deeper into the intricacies of China’s drug master file (DMF) ...