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.

READ HERE
 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.

READ HERE
 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.

READ HERE
 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.

READ HERE
 By Patrick Larcier, Christian K Schneider and Frederic Pailloux

 

FOCUS

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.

READ HERE
 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

READ HERE
 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.

READ HERE
By Victoria Goff and John Knight

 

Topics