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Industry newsWHO Pandemic Agreement gains signatories
The President of UNITE signs statement in support of the World Health Organization (WHO) Pandemic Agreement
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Industry newsWHO issues warning on fake opioids in Europe
The World Health Organization (WHO) has issued an alert that falsified Oxymorphone Hydrochloride has been detected in Finland.
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Industry newsCholera vaccine shortage puts millions at risk
The World Health Organization has declared a worldwide shortage of the oral cholera vaccine amid an upsurge in cases.
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Industry newsWHO endorses use of R21/Matrix-M malaria vaccine in children
The World Health Organization (WHO) has recommended widespread use of the R21/Matrix-M malaria vaccine in children.
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JournalUnique aspects of biologic reference standards
Reference standards are pivotal in ensuring pharmaceutical quality, especially for complex biologics. This article reviews definitions and classifications of reference standards as outlined by the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q6B and Q7 guidelines. It addresses types of standards based on source and use, with particular emphasis on the distinct requirements for biologics.
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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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JournalNavigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives
Adverse events following immunisation (AEFI) are a major concern for vaccine safety and public trust. This article examines the current regulatory systems for AEFI surveillance, reporting and causality evaluation, highlights challenges including underreporting and inconsistent frameworks, and assesses how real-world data and advanced analytics could strengthen post-marketing safety surveillance.
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EditorialTherapeutics: Navigating diverse regulatory pathways
This July/August issue of Regulatory Rapporteur explores how regulatory strategies are shaped by the unique demands of different therapeutic areas. From oncology, rare diseases and paediatrics to influenza, fertility and vaccine safety, we examine the evolving pathways, challenges and opportunities facing product development. Together, these articles highlight the critical role regulatory professionals play in navigating complex and often divergent requirements to support innovation and deliver safe, effective therapies to patients worldwide.
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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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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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