All Access to medicines articles
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ContentsRegulatory Rapporteur April 2026 – Contents
The April issue of Regulatory Rapporteur focuses on access to medicines.
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EditorialAccess to medicines: From approval to
patient-centred deliveryThis issue focuses on access to medicines, and demonstrates how lifecycle regulation, diverse evidence, operational innovation and corss-sector collaboration all contribute to improving the timely, equitable and trusted delivery of medicines.
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JournalRegulatory affairs as a strategic function in market access of medicinal products: Pre‑COVID-19 context, COVID-19 acceleration and post‑COVID-19 convergence across 11 markets
This article looks at how regulator, HTA body and payer interfaces have evolved since the COVID-19 pandemic and how regulatory affairs has become a strategic integrator of regulation, evidence and access
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JournalEmergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
This article explores the FDA’s Emergency Use Authorisation framework and its aim to speed up the deployment of IVDs during public health emergencies, focusing on its evolution, operational mechanisms and significance in public health preparedness.
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JournalBeyond borders: Strengthening regional regulatory frameworks to end substandard and falsified medicines in Africa
This analysis examines the regulatory, economic and supply chain dynamics underpinning the issue of substandard and falsified medicines in Africa, and explores how regional harmonisation initiatives, emerging technologies and strengthened enforcement mechanisms can protect public health across the continent
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JournalThe regulatory valuation of patient experience data in rare diseases: A review of FDA and EMA labelling outcomes and methodological determinants
This article summarises a review carried out to evaluate patient experience data inclusion in regulatory assessements and labelling for rare diseases in the EU and the US
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InterviewFAMHP: The role of the Belgian Agency in advancing public health
This interview with Professor Hugues Malonne, Chief Executive Officer of the Belgian Federal Agency for Medicines and Health Products (FAMHP) discusses the Agency’s role in helping shape regulatory affairs and improving health.
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EditorialVeterinary medicines: Translating regulation into practice
This issue looks at the impact of the Veterinary Regulation 2019/6, the effect of the new EMA fees on marketing authorisation holders, and the regulatory challenges associated with the practical use of bacteriophages in veterinary medicine.
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Industry newsKey milestone reached in African medicines regulation
A key milestone for medicines regulation in Africa has been reached with the first continental listing of five medicinal products by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee.
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EditorialThe global access battle for healthcare equity
Regulatory Rapporteur June 2024 | Volume 21 | No.6 The World Health Organization (WHO) has estimated that one-third of the global population lacks regular access to essential medicines. The concept of access to medicines will likely resonate differently within ...
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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 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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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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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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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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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