Regulatory
Rapporteur
Write to the Editor at publications@topra.org
March 2024 | Vol. 21 | No.3
EDITORIAL
Diverse and dynamic regulation in the Asia-Pacific region
Our first regionally focused issue for 2024 metaphorically travels to the Asia-Pacific (APAC) region. Asia makes up 60% of the global population and there are a large number of regulatory agencies with which to engage, and varying degrees and types of regulations to be considered.
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By Vickie Goff and Harriet Edwards
FOCUS
Navigating the regulatory terrain down under: trends for 2024
The Australian government and Therapeutic Goods Administration are implementing a number of regulatory reforms to strike a balance between timely access to therapeutic products, flexible regulatory pathways for industry and an overall regulatory framework aligned to risk. This article explores some key developments in Australia’s regulatory landscape.
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By David Batka PhD and Kate Burke
FOCUS
Regulatory imperatives in chemistry, manufacturing and controls for biosimilars: a comprehensive analysis in the Asia-Pacific region
The Asia-Pacific (APAC) region has emerged as an attractive market for the development and approval of biosimilars, where meticulous attention to chemistry, manufacturing and controls (CMC) is crucial in navigating this complex regulatory landscape. This article explores the key regulatory processes inherent to CMC for biosimilar assessment and approval across APAC countries.
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By Rajendra Kunda, Rick Best, Steve LoCastro andHao Liu PhD
FOCUS
Can the Japanese phase I study be waived?
The introduction of new guidance means that under certain conditions, non-Japanese companies can run multi-regional clinical trials without needing to conduct a seperate Japanese phase I study. This article discusses the situations where the phase I study could be waived and safety measures for sponsors to consider if a waiver is pursued.
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By Yoshiaki Hattori and Masami Tamura
FOCUS
Overview of digital transformation in healthcare and initiatives for the promotion of digital health products in Japan
Japan has been comparatively slow in adopting digital transformation in healthcare when measured against other developed countries. This article describes the ongoing initiatives and policies introduced by the Japanese government to accelerate digital healthcare.
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By Mohamed Oubihi
STANDALONE
Clinical trial design – keeping up with innovation
Clinical trial designs are evolving at a great pace and relevant guidance is required to maximise the potential of new and emerging trial designs. This article provides an overview of innovative clinical trial designs including platform trials and umbrella trials, and the regulatory guidance associated with them.
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By Sara Goncalves
STANDALONE
New data protection for maximum residue limits
An issue consistently raised in the veterinary sector is the lack of data protection for applicants who submit a maximum residue limit (MRL) dossier. This article discusses the new data protection rules introduced under Regulation (EU) 2019/6 which enable applicants five years of data protection for MRL dossiers.
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By Anja Holm
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