Regulatory
Rapporteur

Write to the Editor at publications@topra.org

September 2023 | Volume 20 | No.8

EDITORIAL

The worldwide web of regulation

In this issue, we focus on the pharmaceutical supply chain and the interaction of this function with regulatory. The supply chain team are the link between the manufacturer and the customer, and they are impacted by the complexity of regulations across different global markets and work with regulatory colleagues to navigate these and ensure delivery of supply.

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By Vickie Goff

FOCUS

Q&A: Navigating the pharmaceutical supply chain

Matthew Scripps, Director of Supply Chain Planning at Mundipharma, occupies a unique position in the pharmaceutical supply chain between the manufacturer and the customer. In this interview, he discusses the challenges and rewards in getting products out to patients.

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By Vickie Goff

FOCUS

Biosimilars CMC development considerations from a sponsor(s) perspective

Given the unmet population’s needs and patient access to biosimilars, there lies a significant opportunity for new sponsors to enter the biosimilars space. This article provides guidance for small and mid-sized sponsors on the complex process involved in biosimilar CMC development, including manufacturing process development and control strategies.

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By Sateesh Babu, Rajendra Kunda, Korampalli Saidarao,
Deepti Jagga, Steve LoCastro, and Allison Gillespie

FOCUS

Navigating the global supply of starting materials for cell-based therapies

The use of biological starting materials in the development of allogeneic cell-based therapies poses several challenges, such as availability of appropriate donors or lack of global regulatory harmonisation around testing requirements. This article provides guidance on how sponsors can safely and effectively navigate this complex environment.

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By Dr Elena Meurer and Dr Jennifer Sales

FEATURE

Warning letters for direct-to-consumer advertising: a five-year retrospective analysis

To protect public health, the FDA keeps a close watch on advertisements by pharmaceutical companies through its Office of Prescription Drug Promotion (OPDP). This study analyses the Warning Letters issued by the OPDP, and identifies the variables which lead to Warning Letters being issued to pharmaceutical companies.

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By Soundarya Rai, Garima Bansal, Akash Chimegave,
Sandeep Maharaj and Manthan D Janodia

FEATURE

Regulatory considerations of a growing pharmaceutical company; a UK/US comparison of the generics industry

Generic medicinal products have become invaluable in healthcare systems around the world, causing use and market share to grow at a fast pace. This study compares the UK and US generics markets, and provides guidance on market entry and regulatory approval for these products.

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By Jenny Lakin