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European Biopharmaceutical Review

Advanced Therapies Regulation

Regulation (EC) No 1394/2007 aims to standardise the regulation of advanced therapy medicinal products (ATMPs) by providing a working definition for ATMPs and introducing special rules to control such products. Until now, ATMPs have largely fallen through the cracks of the existing medicine and medical device regimes in Europe, resulting in uncertainty for the companies involved in researching and developing these products as to the correct regulatory regime for their products, as well as raising broader public concerns regarding the ethics, safety and validity of these products in their designated treatments.

The Regulation aims to address these concerns and provide a clear regulatory pathway for ATMPs, and will apply throughout the EU from 30th December 2008. However, any products falling within the definition of an ATMP under the Regulation which were legally on the market on 30th December 2008 have until 30th December 2009 to comply with the requirements of the Regulation.

ADVANCED THERAPY MEDICINAL PRODUCTS DEFINED

Under the Regulation, the concept of an ATMP is broadly defined in order to capture three specific categories of advanced therapies – tissue engineered products, gene therapy medicinal products and somatic cell therapy medicinal products – with ATMPs described as any medicinal product for human use falling within one of these categories.


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Anthony Warnock-Smith is a Partner who leads the life sciences practice in the London office of international law firm Morgan Lewis. His practice focuses on government regulation, business transactions involving the pharmaceutical, medical device, cosmetics, veterinary drug, and foods and food additives industries. His government regulation experience involves the full range of services of interest to these industries, from clinical trial and product development issues, to marketing and allied reimbursement, product liability and other trade regulation matters. He has also worked on joint ventures, mergers and acquisitions, EU competition law, restructurings, distribution agreements, technology licensing and strategic partnering for these industries.

Natalie Kingston is an Associate in Morgan Lewis’ business and finance practice and is a member of the Global Outsourcing Group. Natalie handles a wide range of regulatory matters, commercial agreements and transactions for clients in the life sciences sector. In addition to acting for pharmaceutical and medical device companies, she also has particular experience advising in relation to foods and cosmetics. Natalie is involved with outsourcing and general commercial and corporate issues including joint ventures, intellectual property and technology agreements.

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Anthony Warnock-Smith
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Natalie Kingston
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