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Regulatory
Rapporteur

Write to the Editor at publications@topra.org

June 2022 | Vol. 19 | No.6

EDITORIAL

How regulators are navigating the evolving pharmacovigilance landscape

In the area of regulatory affairs and pharmacovigilance, we are constantly confronted with new laws, guidelines and other regulations that affect and change our daily work. When do we take the time to look back and ask whether the regulations that were introduced ten years ago have withstood expectations?

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By Birgit Roser and Julie Warner

FOCUS

Evolutions in patient healthcare at the MHRA

Alison Cave, Chief Safety Officer at the MHRA, discusses her role at the helm of the agency’s vigilance responsibilities for both medicines and devices, current key objectives and her future ambitions for improving patient healthcare.

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By Kasia Nowok

FOCUS

10 years of pharmacovigilance legislation: the perspective of a national agency

The human medicines legislative framework has been able to respond to the requirements of the changing regulatory environment. This article evaluates the experience from the past ten years, the lessons learned and changes needed to create an efficient regulatory system.

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By Dr Martin Huber and Dr Karl Brioch

FOCUS

Updates to quality legislation from the EMA

Brian Dooley, Quality Specialist in the Pharmaceutical Quality Office of the EMA, discusses his role, new marketing applications and updates to quality legislation.

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By Victoria Goff

STANDALONE

Exploring Amgen’s Project Orbis experience with sotorasib (Part 2)

Sotorasib is indicated for the treatment of adult patients with KRAS-G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). This case study is the second part of a two-part review and provides regulatory insights into the global collaborative review of the sotorasib marketing authorisation application under Project Orbis.

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By Vandana Pathak, Monica Batra, Jacqueline M Kline and Julie Lepin

STANDALONE

What can past decision-making data tell us about how the FDA will make future combination product categorisation decisions?

In the US, combination products are categorised into drug/biologic or device regulatory schemes based on the primary mode of action (PMOA). However, the determination of the PMOA for complex multimodal and novel combinations are more difficult. The article details how the FDA determines the PMOA for combination products and the importance of early determination.

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By Farha Sayeed