All Regulatory Rapporteur articles in February 2022
Expedited pathways: How expedited pathways benefit patients and the industry Plus: Article: Selection and justification of regulatory starting materials Interview: Building best regulatory practices in Brazil Meeting Report: The EMA’s Veterinary Big Data Stakeholder Forum (Part 2)-
InterviewBuilding best regulatory practices in Brazil
Gustavo 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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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 2)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1–2 June 2021 as a virtual event with more than 500 participants globally connected. This is the second and final part of the meeting report; the first half was published in Volume 19 No. 1 of Regulatory Rapporteur.
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FocusConditional oncology drug approvals: A sponsor’s perspective on the evolving landscape of FDA accelerated approvals
The FDA’s accelerated approval (AA) pathway is an important regulatory mechanism that allows patients with serious or life-threatening conditions, potentially earlier access to treatments than under a standard, regular approval development pathway...
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FocusNew regulatory tools for drug developers: sharing experience
Advances of knowledge in therapeutic areas have led 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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FocusTime is running out for the rare pediatric disease designation and priority review voucher programs
Since 2012, the rare paediatric disease priority review voucher (RPD PRV) program in the US, provides incentives to promote research in leftover orphan paediatric disease...
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EditorialRegulatory 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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JournalSelection and justification of regulatory starting materials
A regulatory starting material (RSM) is the registered point at which drug substance manufacturing under good manufacturing practice (GMP) begins. RSMs are defined, 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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