Some of us may have seen the 1966 movie ‘Fantastic Voyage’ where a team of doctors was miniaturised and injected into a man to operate on a blood clot in his brain. This movie, although farfetched, showed a futuristic glimpse into the capabilities and applications of nanotechnology.
One of the most promising applications of nanotechnology is in Nanomedicines. Nanomedicines can be defined as the application of nanotechnology to medical diagnostics, therapies and prevention. The future applications of nanomedicines will involve engineered molecules to develop drugs, drug delivery systems, diagnostics, medical devices and advanced gene therapy and tissue engineering procedures.
Role of Regulation in Innovative Drug Development.
The present drug discovery and development process has been in existence for around 100 years. The process of discovering new potential targets, components within a biochemical pathway that may be linked to causation of certain diseases, and developing compounds which show promising interaction with the target, is one of the most exciting areas of scientific discovery today. This process is, however, complicated, time consuming and very expensive.
As of the 4th of August 2013 Commission Regulation (EU) No 712/2012 will be implemented into the EU, making a large number of changes as to how variations will be processed. It has been over three years since the EU variation legislation was updated when Commission Regulation (EU) 1234/2008 came into force, changing important fundamentals concerning how variations to licences are categorised and processed. Since January 1st 2010 national Health Authorities have been adopting this legislation into their processes for National Marketing Authorisations. Subsequent to the collective experiences of the preceding years a number of refinements have been set in place and form the framework for this legislative update. Perhaps the most important one of these is the mandating of all EU markets to adopt this new way of working.