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European Biopharmaceutical Review

Regional Requirements

Globalisation has affected the life sciences and pharmaceutical industries just as much as it has other sectors, and a growing push to standardise submission formats has opened market opportunities for many life sciences companies. The common technical document (CTD) has already become the de facto standard in many regions as more and more countries respond to the ICH’s mission of greater harmonisation around the “interpretation and application of technical guidelines and requirements for pharmaceutical product registration” (1).

Regional Regulatory Climate

Today, most countries – either directly or through regional agencies – are members of the ICH or observe its guidelines. Through ongoing consultations between ICH and regulatory agencies, most regions of the world either have adopted – or are working towards meeting – the ICH guidelines centred on the areas of quality, safety, efficacy and multidisciplinary regulatory issues.

Even though most countries and regions are still paper-based, the push towards electronic submission is growing, and more countries are adopting or at least exploring electronic CTD initiatives. However, regional differences remain, even where strong alliances and a structured approach to regulatory submissions exist.

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Kimty Bui-Van is head of regulatory and pharma services practice at ProductLife Group, where she is responsible for the coordination of all regulatory affairs activities undertaken on behalf of clients. She draws on nearly 20 years of experience in regulatory affairs, both within the industry and as a consultant, to guide clients through all aspects of regulatory affairs, including initial submissions, variations, renewals and product lifecycle management. Kimty has been instrumental in establishing a transformative approach to managing affiliate regulatory and pharmacovigilance activities globally on behalf of clients. 
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