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European Biopharmaceutical Review

Standing Together

Two types of medical products were previously known in the EU regulatory framework. Firstly, medicinal products (for example, drugs) and secondly, medical devices comprising simple objects such as tubing, as well as complex instruments like pacemakers. Scientific discoveries have led to the development of additional entities such as active pharmaceutical ingredients. On the one hand are proteins like antibodies, and on the other are living cells and tissues.

Beyond cells and cell aggregates considered for replacing diseased tissue, genetic engineering has provided the tools to address genetic diseases, so that constructs containing recombinant nucleic acids have also become drug candidates. Products generated by these technologies fitted into neither of the existing classes of medical products so that, at the time, a manufacturing licence was often sufficient to put such new medical products onto the market. Recognising these new scientific developments, as well as the gap in the existing regulatory framework, a new class of medicinal products was created in the EU and was termed advanced therapy medicinal products (ATMPs).

ATMP Regulation


This new class of medicinal products comprises all of the above; that is, products derived from principles of cell therapy, tissue engineering and gene therapy. At the core of the newly created regulatory framework is the EU regulation 1394/2007 – here referred to as the ATMP regulation – that came into force in 2008. Being a regulation rather than a directive, it immediately became effective across the EU.

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Dr Christian van den Bos, PhD, founded Mares Ltd in 2007 to accelerate the development of regenerative medicinal products, and currently serves as its Managing Director. Based on his experience, Christian has been recognised as a Qualified Person according to EU drug laws for cell-based medicinal products. He underwent postdoctoral training at Cold Spring Harbor Laboratories, US, and earned a PhD at the University of Münster, Germany and an MSc at the University of Oxford, UK.

Somaiah MN is a regulatory affairs professional with regulatory, clinical and quality assurance expertise, from the pharmaceutical, biotechnology and stem cell industries. His background includes working for AstraZeneca, Bristol-Myers Squibb, Mallinckrodt and Biocon. Somaiah has technical experience in drug product and clinical trial registration, ISO certification for manufacturing plants, coordinated Health Authority Inspection of manufacturing plants and has obtained WHO-GMP certificates. He has an MSc from Mangalore University, India.

Dr Beate Walter, PhD, is a Medical Writer at CONVIDIA clinical research GmbH, and is well experienced in publication management and Medical Writing. She is a member of the European Medical Writers Association. Before CONVIDIA, she worked as a postdoctorate in preclinical research covering infectiology, oncology and biochemistry. Beate has a PhD and an MSc from the University of Münster, Germany.

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Dr Christian van den Bos
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Somaiah MN
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Dr Beate Walter
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