All Chemistry, manufacturing and controls (CMC) articles
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JournalA year of change for the US FDA: An update on notable pilots and programmes
This article updates on the FDA’s pilots and programmes that have been launched and also ongoing projects in 2025.
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ContentsNovember 2025 – Contents: Medical devices/IVD sessions
The November issue of Regulatory Rapporteur reports on the medical devices/IVD sessions from the TOPRA Symposium 2025.
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ContentsNovember 2025 – Contents: Human medicines sessions
The November issue of Regulatory Rapporteur reports on the human medicines sessions from the TOPRA Symposium 2025.
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ContentsRegulatory Rapporteur November 2025 – Contents
The November issue of Regulatory Rapporteur reports on sessions from the TOPRA Symposium 2025.
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JournalHM6: How Artificial Intelligence is transforming regulatory approaches towards chemistry, manufacturing and controls (CMC)
This is a report of the HM6 session that took place at this year’s Symposium.
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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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JournalCentral sourcing of authorised comparators and concomitant medications for multiregional clinical trials in accordance with ICH E17: CMC documentation requirements
This article uses the ICH E17 document to explore chemistry, manufacturing and controls requirements for inclusion in a clinical trial application.
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EditorialFrom trials to approval: Regulatory strategies in early drug development
This issue focuses on the acceleration of early drug development, the opportunities and challenges that this brings and strategic guidance for regulatory professionals.
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ContentsRegulatory Rapporteur October 2025 – Contents
The October issue of Regulatory Rapporteur focuses on early drug development.
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JournalDigital transformation of global regulatory affairs: Then, now and next
This article explores GenAI and Health Level 7’s (HL7) next generation standard for Fast Healthcare Interoperability Resources (FHIR).
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EditorialAdvanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
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JournalGene Therapy Medicinal Products: An examination of regulatory CMC requirements
This article explores the CMC requirements for GTMPs to help ensure high quality and safe products are brought to market.
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JournalConsiderations in the development of allogenic and autologous cell therapies
Autologous cell therapy involves the use of a patient’s own cells which are harvested, modified or expanded ex vivo and then reintroduced into the patient. Allogeneic therapies use cells from a donor modified or expanded ex vivo and then administered to the patient.
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PodcastsRegRapPod − February 2024
Vol.21 #2: In February 2024’s RegRapPod, host Alan Booth talks to Issue Editors Dejan Brkic and Esteban Herrero-Martinez about medtech.
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Podcasts
RegRapPod − January 2024
Vol.21 #1: In January 2024’s RegRapPod, host Alan Booth talks to Issue Editors Julie Warner and Ash Ramzan about biologics.