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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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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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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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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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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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JournalThe use of prior knowledge and platform approaches in early vaccine development
This article explores how platform approaches and prior knowledge can be used in the early development of vaccines.
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JournalTarget product profile and product profile characteristics for labelling during drug development
This article analyses the role of the TPP and PPC in labelling development and uses case studies as examples.
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Lean Six Sigma in post-market surveillance: Insights for EU 2017/745 MDR Article 88 and Great Britain SI 2024/1368 (44ZN) trend reporting compliance
Emergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
TOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
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