Low level of drug innovation European drug regulatory agency: must speed up

Business Club December 28th The low level of drug innovation in the pharmaceutical industry means a major public health problem and a huge waste of capital investment and the reliance of pharmaceutical companies and regulators, leaving the outgoing European Medicines Agency Director Thomas • Ron Engelin said on December 15.

It is estimated that in the world’s huge investment of US$85 billion in drug research and development each year, if we count the number of new molecular entities that are put into production, approximately US$60 billion will be wasted each year and take over the European Medicines Agency for ten years. The outgoing Thomas Longnigren said.

“How many new drugs are approved each year? Maybe 6, 7, 8, 9. If the few new drugs worth 10 billion, maybe 20 billion U.S. dollars, then the rest of the 850 billion U.S. dollars Where does it flow?” Mr. Ron Enger asked such a question at a seminar at the headquarters of the European Medicines Agency in London. "Maybe we can make better use of this $60 billion in huge sums of money?" he added.

He said that in the past 10 years, pharmaceutical companies have not invested in drugs that can solve the needs of public health in key areas, such as antibiotics. At the same time, there has been a large increase in bacteria that are resistant to currently available antibiotics.

In an interview with Dow Jones Newswires and his evaluation of the head of the European Drug Regulatory Agency for 10 years, Mr. Ron Engeln said that large pharmaceutical companies may have to focus their R&D resources on disease prevention and control.

Another problem, in his opinion, is that pharmaceutical companies reduce R&D investment in the treatment of central nervous system disorders, such as Alzheimer's disease. When talking about the future trend of regulation, Mr. Ronn Gren said that the evolutionary dynamics from within the global industry are driving more interaction and cooperation among regulators - a trend that has prompted regulators to assume broader responsibilities and events. Make a quicker response.

He mentioned the coordinated actions taken by the US FDA and the European Medicines Agency in September this year regarding GlaxoSmithKline’s disputed diabetes treatment drug, Avandia. In this historical record, when the European drug administration announced the suspension of sales of Avandia, US regulators also announced strict restrictions on Avandia, effectively ending Glaxo's annual sales of up to tens of times. Billion-dollar medicine is widely used.

He said that drug regulatory agencies and medical technology evaluation agencies like the National Institute for Clinical Optimization (NICE) in the UK will increase cooperation and interaction in the future. NICE is responsible for the distribution of medicines that are funded by public funds funded by the British National Health Service (NIS).

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