Regulatory
Rapporteur

 

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June 2024  |  Vol. 21  |  No.6

EDITORIAL

The global access battle for healthcare equity

This month’s issue focuses on access to medicines, a concept which will likely resonate differently within the various regulatory speciality areas. However there are ultimately five common factors that include availability, affordability, accessibility, acceptability and quality.

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By Davina Stevenson

FOCUS

Project Orbis — a sponsor’s perspective on the collaborative international review process

A sponsor’s decision to participate in Project Orbis is influenced by a number of factors, including the complexity of the application and the potential for faster review timelines. This article summarises AstraZeneca’s experiences with Project Orbis, including strategic considerations for participation, and the challenges and opportunities during the review process.

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By Allison Guy, Elinore Mercer, Anna Litsiou, Carolyn Hynes, Priti Shah and Shaily Arora.

FOCUS

A key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation

The need for early collaboration between regulators and European Health Technology Assessment (HTA) bodies has long been acknowledged, however collaboration is not always common practice. The HTA Regulation (EU) 2021/2282 has been developed to harmonise the approach to HTAs across the EU. This article discusses the EU-HTAR, which will develop a permanent partnership between the EMA and national HTA bodies.

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By Rosa Willock, Sophia McGovern and Sarah Cocklin

FOCUS

The availability of medicines in Malta post-Brexit

Restricted availability of medicinal products has been experienced across the European Union (EU) member states following Brexit. Malta has historically sourced many of its medicinal supplies from the UK, and this lack of availability represented a risk to patients’ access of medicines. This article discusses how Brexit has affected medicines availability in Malta.

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By Yvette Anne P. Patrocinio

FOCUS

Opportunities and challenges in the Latin America pharmaceutical industry

The regulatory affairs landscape in Latin America presents a blend of challenges and opportunities for pharmaceutical investment and expansion. This article discusses Latin America’s position in the global pharmaceutical industry and the current initiatives in place to strengthen regulatory systems across the region and foster harmonisation.

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By Miguel Manuel Lewis

STANDALONE

The UK Responsible Person Association (UKRPA)

Established after Brexit, the UK Responsible Person Association (UKRPA) was created to represent and promote professionals working as a UK Responsible Person (UKRP) in the medical technologies sector. This article discusses the evolving role of the UKRP and the future requirements such as post-market surveillance.

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By Mika Reinikainen

STANDALONE

Over two years into the new veterinary medicines rules for the European Union: a reflection

The European Union’s Veterinary Medicines Regulation (2019/6) became applicable on 28 January 2022 following a three-year transition period for all parties. This article reflects on the steps that were taken to fulfil the significant changes required by the Regulation.

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By Rick Clayton

STANDALONE

China Drug Master File (DMF) compared with the EU and the US

This is the third article in a six-part series that focuses on the regulations in China’s drug market. It provides a comparative analysis of China’s regulatory requirements to those of the EU and the US, in areas including registration pathways and post-marketing responsibilities.

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By April Wang