The European Commission's consultation on revising the In Vitro Diagnostics Directive (98/79/EC) has revealed that some stakeholders want the European Medicines Agency to become involved in regulating companion diagnostics, ie IVDs that are ...
A recent PricewaterhouseCoopers report estimated that the core diagnostic and therapeutic segment of the US personalised medicine market is worth $24bn. This figure is expected to nearly double by 2015, reaching $42bn. Peter Charlish investigates ...
The Asian Harmonisation Working Party , which represents the medical device community in Asia and several other countries, is seeking to identify the “obstacles and difficulties” faced by member economies in regulating in vitro diagnostic devices ...
US oral fluid diagnostics specialist OraSure Technologies has appointed Robert Gregg vice president of regulatory affairs and quality assurance. Dr Gregg will be responsible for the Bethlehem, Philadelphia-based firm’s regulatory, quality assurance ...
Health Canada has developed a draft keyword index to help manufacturers of in vitro diagnostic devices classify their products into the appropriate risk class 1 ,2 . Its use – in conjunction with the document entitled Guidance for the Risk Based ...
Australia’s Therapeutic Goods Administration has proposed new requirements to ensure that the contaminant over-sulfated chondroitin sulfate (OSCS) is not present in the anticoagulant heparin 1 . The requirements are listed in a draft Therapeutic ...
Maureen Kenny reports on efforts by the European Medicines Agency to ensure manufacturers of advanced therapies won't be caught out by approaching approval deadlines. At least 20 advanced therapy medicinal products that are currently on the market ...
The Human Fertilisation and Embryology Act 2008 came into force in the UK on 1 October 1 ,2 . The law ensures that all human embryos outside the body – whatever process used in their creation – are subject to regulation, said the Department of ...
A new European Union directive (Directive 2009/120/EC) has been published that amends the main human medicines directive (Directive 2001/83/EC) as regards advanced therapy medicinal products 1 ,2 . Directive 2009/120/EC amends Annex 1 (Part IV) of ...
The European Commission has formally adopted a new procedure that will allow small and medium-sized enterprises to use a new procedure for certifying their early quality and nonclinical data on advanced therapy medicinal products 1 ,2 . The ...
A cell-based medicine for repairing knee damage has become the first product to be recommended for approval by the European Medicines Agency under the European Union’s new advanced therapy regulatory framework 1 . ChondroCelect, which is produced by ...
The European Medicines Agency is taking steps to deal with the additional workload involved in implementing the European regulation on advanced therapy medicinal products (Regulation (EC) No 1394/2007), which came into force on 30 December 1 . The ...
The Irish Medicines Board , having found no takers for a new service it started last year to offer formal scientific advice on the drug component of drug/device combination products, is planning to charge a reduced fee for the job 1 ,2 . Reacting to ...
The US Food and Drug Administration , responding to concerns over the lack of specific postmarketing safety reporting requirements for combination products, has issued a much-awaited proposed rule to address the issue 1 . In addition to requiring ...
Health Canada has decided to put on hold a new product licensing requirement under which manufacturers of medical devices with a drug component were required to provide the Drug Identification Number (DIN) of the product’s medicinal component to ...
