Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

May 2022  |  Vol. 19  |  No.5

 

 

EDITORIAL

CMC acceleration is driven by a scientific revolution

The role of chemistry, manufacturing and controls (CMC) technical regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals.

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 By Victoria Goff and Satish Muchakayala

 

FOCUS

CMC considerations for US biosimilars development

The abbreviated licensure pathway for biosimilar products requires knowledge of the essential chemistry, manufacturing and controls (CMC)-related considerations for development. This article discusses the importance of chemistry, manufacturing and controls (CMC) data in a biosimilars application.

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 By Merry Christie, Alexandra Beumer Sassi and Valerie Pimpaneau

 

FOCUS

Gene therapy products: regulatory expectations and challenges for industry

As the technology behind gene therapies continues to evolve, applicants face the challenge of adapting their programmes to increasingly demanding and detailed regulation. This article provides an overview of current regulatory expectations and the challenges they may present to industry.

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 By Francesca Lanucara

 

FOCUS

Regulatory framework for platform technologies

Several novel manufacturing technologies and platforms have recently emerged to produce vaccines and advanced therapy medicinal products (ATMPs) for human use. This article discusses the regulatory guidance for platform technologies and recommendations for the future.

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 By Satish Muchakayala

 

STANDALONE

When an application for a new veterinary medicinal product is submitted through a mutual recognition or decentralised procedure, the applicant can prematurely withdraw their application in the reference member state or in one or several of the concerned member states. Given the increase in partial withdrawals, this article considers how the transparency and communication regarding these procedure withdrawals could be improved.

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 By Laure Baduel

 

STANDALONE

Practical insights into the recent EU MDR framework

This article focuses on the impact of the new guidance document on drug-device combination products in Article 117 of the European Medical Device Regulation (MDR). It also provides practical insights into key technical requirements for the product-specific quality of a medical device.

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 By Akhilesh Sharma et al.

 

STANDALONE

A regulatory view on the change management process for medicinal products

An effective control process is a critical part of good manufacturing practice during the post-approval phase of the medicinal product lifecycle. This article reviews key aspects of the current EU and International Conference on Harmonisation quality guidelines.

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 By Julien Douillet

 

STANDALONE

Amgen’s experience of global expedited regulatory pathways in the development of sotorasib (Part 1)

Sotorasib was the first approved targeted therapy for the treatment of adult patients, with previously treated KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Part 1 of this two-part case study provides regulatory insights into the global expedited pathways and special designations utilised during the development and marketing application review of sotorasib.

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

 

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