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Modernising the Process

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.

The report noted that the development of new medicines was increasingly difficult and that scientific tests used to develop drugs and evaluate their safety needed updating. There was concern that inconsistent standards and outdated practices needed to meet FDA guidance often led to long, expensive studies and little benefit to public health.

The Critical Path Initiative was launched to update the scientific process by which a potential drug, biological product or medical device becomes an approved and licensed product. It concerns the tests and tools used to predict the safety and effectiveness of products, dose regimes, how devices are used and the tools used to manufacture the product commercially.

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European 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.

It is expected to modernise the development of medicines, expand European expertise to attract investment in European biomedical research, provide more jobs for research scientists in Europe and strengthen the competitive position of smaller companies, helping the European economy.

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