This article reviews the impact of the new pharmaceutical legislation on the development of biotech products. The authors describe in details current and new challenges that will have an impact on the development and preparation of the registration dossier of...

Manufacturers of Human Tissue Engineered Products (HTEPs) need to develop a very strong position paper to put an end to regulators treating so many of these products as cell therapy products and compelling manufacturers to comply with the medicinal products...

The industry is caught between wanting numerous questions answered in the text and a rapid implementation of new rules to end the current fragmented regulatory "nightmare" that currently exists in Europe.

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.

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.

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

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