Regulating innovative biomedical products based on nanotechnology requires a combination of drug and device evaluation expertise. Economic forecasts predict the market growth of nanotechnologies will reach hundreds of billion euros in the coming decade.

...

The European Commission issued a proposed regulation in November 2005 on Advanced Therapy Products aiming to provide the much awaited harmonized regulatory framework for cell-based products. This Regulation includes somatic cell therapies, gene therapies and also...

In 1991 the European Commission (EC) initially proposed a clinical trial regulation rather than a directive. Although a regulation typically results in greater harmonization, unfortunately some member states preferred that the EC issue a directive that could be...

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...

Pages