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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 & 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, 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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By Harriet Edwards

FOCUS

Alternatives to animal testing
in the development of ATMPs

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. 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.

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By Monika Staniulyte & Insuvia