A July 2009 adoption/publication of a revised Annex I of Directive 2001/83/EC is foreseen. Discussions on how to appropriately assess combined ATMPs are advanced, with the CAT medical device experts directly involved in these discussions.

...

As major pharma companies position themselves to market drugs in years to come, they’re seeing fewer blockbuster therapies on the horizon. The future lies in following the development model used by biotech companies to advance new medicines designed to target...

Demand for contracted services in the European biotech sector is buoyant. As the industry matures and more biotech drug candidates reach clinical development, business opportunities for contract research organizations (CROs) and other service providers are growing...

The main purpose of the tissues and cells directives has been to define a minimum level of quality and standards to support the expanding field of transplantations of human tissue and cells in the European Economic Area. The implementation of the EU tissues and...

As for chemicals, the development of numerous biopharmaceutical products has been accompanied during the last 15 years by a sustained and joint effort of the Regulatory Authorities and the Industry to set up contributory regulatory guidelines.

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...

Pages