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WHO Pandemic Agreement gains signatories

2024-10-23T14:40:00Z

The President of UNITE signs statement in support of the World Health Organization (WHO) Pandemic Agreement

WHO issues warning on fake opioids in Europe

2024-09-16T09:22:00Z

The World Health Organization (WHO) has issued an alert that falsified Oxymorphone Hydrochloride has been detected in Finland.

Unique aspects of biologic reference standards

2025-01-10T08:50:00Z

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.

Cholera vaccine shortage puts millions at risk

2024-04-03T11:04:00Z

The World Health Organization  has declared a worldwide shortage of the oral cholera vaccine amid an upsurge in cases.

WHO endorses use of R21/Matrix-M malaria vaccine in children

2023-10-31T12:29:00Z

The World Health Organization (WHO) has recommended widespread use of the R21/Matrix-M malaria vaccine in children.

The global access battle for healthcare equity

2024-06-11T15:30:00Z

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 ...

Divergence on the definition of regulatory reliance in international regions: Is there room for convergence?

2025-06-06T14:08:00Z

The article explores how reliance pathways can be used for MAAs and incorporates AstraZeneca’s research findings on this topic.

Key milestone reached in African medicines regulation

2025-04-07T09:02:00Z

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.

​Gene Therapy Medicinal Products: An examination of regulatory CMC requirements

2025-05-01T09:43:00Z

This article explores the CMC requirements for GTMPs to help ensure high quality and safe products are brought to market.

VM1: Advancing regulatory policies for One Health – A holistic approach to animal and public health

2024-11-08T06:57:00Z