The European Commission’s proposal for a Regulation on Advanced Therapy Medicinal Products (ATPs) is a significant step towards EU-wide harmonization, clarity and certainty for tissue engineered products. But the new clarity comes at a significant cost to the...

Anne Dupraz Poiseau and Stuart Mudge examine the European Commission's proposal for a regulatory framework for human tissue engineered products.

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Determining the regulatory path for a combination product is a difficult task. Even in the USA, which seems to have given the most consideration for and focus on defining and regulating combination products, it still involves much uncertainty.

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This document summarizes VCLS’s comments on the Draft Regulation and on the Consultation Paper, published by the European Community on 4 May 2005. They concern the scope of the Regulation, the composition of the Committee for Advanced Therapies, the requirements for...

Although the major drug development regions of the world are recognized to be North America, Europe and Japan, continuing growth of the pharmaceutical market into emerging regions is being accompanied by similar growth in clinical trial activity outside the...

Research in the Rhone area is particularly developed in academic laboratories, hospitals with people of international reputation working on dermatologic aspects. This led the ARTEB to launch a study on the area of ​​skin reconstruction, and bone cartilage to...

Anne Dupraz Poiseau, Anne Virginie and Stuart Mudge report on efforts to create legal definitions for human tissue-engineered and cell therapy products.

Anne Dupraz-Poiseau, Anne Virginie, Stuart Mudge

2004 - The Regulatory Affairs Journal
The...

Despite the increasing range of guidance documents available, and the best efforts of those involved in producing them, product development sponsors are often faced with challenges that require a “case-by-case” and a “scientific-based” approach.

Stuart Mudge...

Regulation (EC) No. 141/2000 1 of the European Parliament and of the Council on Orphan Medicinal Products was drafted on December 16, 1999 and formally adopted by the European Commission on April 27, 2000. This regulation established a Community procedure for...

Technical advancements in molecular and cellular biology have the potential to provide an amazing array of human tissue engineering products (hTEP), and in doing so may revolutionize medical practice. The range of potential applications and the marketing potential...

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