All Regulatory Rapporteur articles in May 2023
View all stories from this issue.
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Industry news
MHRA seals deal for fast international recognition routes
UK agency adopts recognition routes from seven national authorities; new signals start of new international framework for medicines.
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Podcasts
RegRapPod – May 2023
Vol. 20 #5
In this episode of RegRapPod, host Alan Booth, the managing editor of Regulatory Rapporteur, hears from May’s Issue Editor, Harriet Edwards, about the rapid developments in advanced therapy medicinal products and the tensions that arise between regulation and innovation. -
Journal
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).
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Journal
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, highlighting the crucial need to introduce dedicated legislation to ensure that GETs are developed and maintained in a safe and effective manner.
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Editorial
Mind the gap:
Innovation vs
regulation of ATMPsTechnology 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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Journal
Alternatives to animal testing
in the development of ATMPsThis 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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Journal
Regulatory guidelines for
nutraceuticals in IndiaThe regulatory landscape for nutraceuticals in India, and the required approval processes for market
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Journal
Ensuring promotional
materials’ compliance
in the EUDirective 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. This is in addition to general consumer protection laws and unfair commercial practices regulations and directives. While Directives are legally binding and directly applicable to all companies. Some granularities can be introduced when it is transposed into national legislation by Member States (MS) individual legislatures.