Harriet Edwards
Harriet Edwards is Associate Director, Regulatory Affairs, at Alan Boyd Consultants Ltd., UK.
EditorialDiverse and dynamic regulation in the Asia Pacific region
Starting in Australia, authors David Batka and Kate Burke look at the trends within its market for 2024. Two years ago, the Australian government and its regulatory agency, the Therapeutic Goods Administration (TGA), initiated an expert review of medicine and device regulations to bring about reforms for patient access, flexible ...
JournalG-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.
EditorialMind 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.
JournalNavigating the regulatory landscape for regenerative medicines in Japan
This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines…[1],[2]