Regulatory
Rapporteur
Write to the Editor at publications@topra.org
February 2022 | Vol. 19 | No.2
EDITORIAL
Regulatory support for drug development – maximising options for timely patient access
As medicinal innovation evolves and becomes more complex, there is a need for agencies to support this innovation by establishing additional expedited pathway routes to improve drug development and its evaluation.
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By Joan Boren and Marie Deneux
FOCUS
Building best regulatory practices in Brazil
Gustav Mendes Lima Santos, General Manager of Medicines and Biological Products at ANVISA, explains how the agency has aligned with best practices of others across the world, and discusses important updates to legislation in Brazil.
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By Victoria Goff
FOCUS
Conditional oncology drug approvals: a sponsor’s perspective on the evolving landscape of FDA approvals
The FDA’s accelerated approval pathway allows patients with serious or life-threatening conditions. This article provides a review of global conditional approval pathways with a focus on oncology, and the potential for future changes.
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By Bhargavi Pandit, Ian Martin and Rana Ezzeddine
FOCUS
New regulatory tools for drug developers: sharing experience
Advances of knowledge in therapeutic areas have led to an ease in the development of and access to complex medicinal products. This article discusses the regulatory tools in drug development and regulatory science for drug developers.
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By Patrick Larcier, Christian K Schneider and Frederic Pailloux
FOCUS
Time is running out for the rare paediatric disease designation and priority review voucher programmes
The rare paediatric disease priority review voucher programme provides incentives to promote research in leftover orphan paediatric disease. However, given the time required for development of biologics, only late-stage programmes can benefit from the priority review voucher. This article discusses the advantages and disadvantages of the two programmes.
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By Bertrand Coquet and Valerie Salenty
MEETING REPORT
The EMA’s Veterinary Big Data Stakeholder Forum (Part 2)
The Veterinary Big Data Stakeholder Forum took place between 1-2 June 2021 as a virtual event. This is the second and final part of the meeting report
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By Kornelia Grein, Will Drury and Pascale Canning
STANDALONE
Selection and justification of regulatory starting materials
Regulatory starting materials are defined as isolated materials that are required to meet the general principles outlined in ICH Q11. This article provides guidance for small molecules in selecting and justifying starting materials from a risk-based perspective.
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By Victoria Goff and John Knight
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