Pharmaceutical companies that seek out and comply with scientific advice offered by the European Medicines Agency are more likely to receive positive opinions on their marketing authorization applications than those that do not, according to statistics released by the EMEA.
The European Medicines Agency and the US Food and Drug Administration plan to broaden the scope of a five-year old agreement which enables them to share confidential information submitted to them by pharmaceutical companies.
National European regulatory authorities are developing common criteria for assessing applications for multi-centre clinical trials, something that is expected to reduce the cost of conducting these studies in Europe.
The UK government has reached an agreement in principle with the pharmaceutical industry to create incentives for primary care physicians to prescribe new medicines in exchange for a voluntary 2% reduction in the prices charged to the National Health Service (NHS) for branded medicines.
There has been a gradual, but fundamental shift in the way regulatory agencies interact with the pharmaceutical industry, so that it is now commonplace for companies to meet with regulators before drug development gets into full swing.
The European Medicines Agency (EMEA) is recommending that marketing authorisations be granted for new treatments for neuromuscular block and nosocomial pneumonia. It also recommended that extensions of indications for three marketed cancer drugs be approved.
Two drug applications that were under review by the European Medicine Agency’s main scientific committee have been withdrawn by their sponsors following the committee’s request for more data.
Five new investigational medicines have been recommended for designation as orphan medicinal products by a committee of the European Medicines Agency. Producers of orphan-designated products may be eligible for grants and regulatory fee reductions.
The UK House of Commons defeated opponents of a proposal to allow research using hybrid embryos. As a result, research involving hybrids will be allowed under a bill that updates the UK Human Fertilisation and Embryology Act 1990.
The Innovative Medicines Initiative (IMI) has launched its first call to researchers to submit proposals to work with the pharmaceutical industry to investigate ways of speeding up the drug development process.