Regulatory Rapporteur
Write to the Editor at publications@topra.org
May 2023 | Volume 20 | No.5
EDITORIAL
Mind the gap:
Innovation vs regulation of ATMPs
Technology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.
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By Harriet Edwards and Julie Warner
FOCUS
G-E-T-ting there – how gene editing technologies could change more than genes
The field of genome editing technologies (GETs) is rapidly advancing, marking a new and exciting era of curative medicines. These products can alter genetic material in patients, demonstrating the need to introduce dedicated legislation. This article explores the challenges associated with regulating this sub-class of medicines.
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By Harriet Edwards
FOCUS
Alternatives to animal testing
in the development of ATMPs
Many regulatory authorities have brought in measures to minimise animal testing during medicines development. This article looks at a range of innovative non-animal test methods, including in vitro tests based on human and animal cells, genomic technologies and in silico modelling.
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By Michaela Sharpe
FOCUS
Evolution of GMO requirements for
innovative investigational medicinal
products upon transition to the EU CTR
The EU CTR replaced the EU CTD on 31 January 2022, which impacts investigational medicinal products that fall under genetically modified organisms (GMO-IMPs). This article discusses the specificities of the new CTR process for GMO-IMPs and updates on the GMO application processes in light of these changes.
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By Sabine Ruhl et al
FEATURE
Ensuring promotional materials’
compliance in the EU
Directive 2001/83/EC is the EU legislation specifically covering promotional materials for the pharmaceutical industry – notably, Title VIII Advertising and Title VIIIa Information and Advertising. Applicability may vary under certain circumstances, and this summary, based on a webinar delivered by Insuvia, looks at the implications of deviating from this legislation.
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By Monika Staniulyte and Insuvia
FEATURE
Regulatory guidelines for
nutraceuticals in India
Nutraceuticals are widely used to aid the prevention of various diseases. This article explores the required approval processes for placing nutraceuticals on the market.
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By Nikita Kolekar and Kinjal Bera
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