Modernización del proceso
Recently, there has been a call for a review of the drug development process. The FDA in the United States published a report noting that despite enormous advances in biomedical technology, fewer drugs are being approved as medicines. This indicates that the drug development process itself has fallen behind the pace of emerging technologies. A thorough review of current practice is being undertaken, and similar modernisation initiatives are now taking place in Europe. The outcomes of these initiatives will have implications for the way that medicines are developed in territories throughout the world.
FDA Critical Path
"Innovations in clinical trial design and new animal models that more accurately mimic human disease rarely make headlines. But without them, we would not have the medical products we use today. And without more modern, more predictive tools, we will not have the products of tomorrow."
The FDA is responsible for regulating and licensing all foods and medicines in the USA. In March 2004 they launched a new initiative to modernise the process of drug development. It followed a White Paper showing that a decreasing number of new medicines were being submitted to the FDA for approval, seemingly at odds with recent advances in biomedical sciences.
Back to the topEuropean Commission Innovative Medicines Initiative
"For the first time, competitor pharmaceutical companies will collaborate to find solutions in order to overcome the research bottlenecks in the drug development process."
The IMI is a public-private-partnership between the European pharmaceutical industry and representatives of the EU countries, whose aim is to make Europe a world leader in pharmaceutical research, benefiting the economy and society. This will involve removing the bottlenecks in the process of developing new medicines.
Back to the topLast edited: 5 November 2014 10:58