Chemistry, Manufacturing and Controls content
ICH Q6(R1): Harmonising specifications for chemical and biological products
This article provides an overview of the key concepts and anticipated impacts of the upcoming revision of ICH Q6(R1), highlighting how the integrated approach may reshape expectations for both traditional and innovative pharmaceutical products.
Regulatory reforms in China: Strengthening excipient quality and accession to PIC/S
This article explores new initiatives in China to strengthen the quality supervision of pharmaceutical excipients and pharmaceutical packaging materials.
Managing ATMP lifecycle complexity: Navigating post-approval CMC divergence in Asia-Pacific
This article reviews three post-approval CMC challenge areas in ATMP development: ongoing data commitments, comparability requirements for manufacturing process changes and variation classification, and proposes a five-point framework intended for practical use within the current Asia-Pacific regulatory environment
Navigating divergence: Practical lessons from the UK lifecycle management of licences
Four case studies demonstrate how marketing authorisation holders can optimise UK lifecycle strategy through the strategic use of national routes, the International Recognition Procedure and parallel submissions, despite increasing EU-UK regulatory divergence.
The drug development lifecycle: Regulatory milestones and pathways for early-career professionals
Aimed at aspiring or newly appointed regulatory professionals, this article outlines key stages of the drug development lifecycle and highlights the critical role regulators play throughout the process.
Beyond 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
