Regulation & Policy

The European Medicines Agency has recommended that five new medicines be given marketing authorisations. 

Eight new investigational medicines have been recommended for orphan designation by a committee of the European Medicines Agency. Sponsors of orphan-designated products may be eligible for grants and regulatory fee reductions.

In another step to require prompt reporting of clinical trial data, the US Food and Drug Administration (FDA) has sent a letter to GlaxoSmithKline demanding that the company supply a full report on the results of postmarketing studies conducted for the diabetes drug, Avandia (rosiglitazone maleate). The demands are contained in a Warning Letter dated 25 March 2008 to Jean-Pierre Garnier, GSK’s chief executive officer. The letter has been posted on the FDA’s website, www.fda.gov.

The UK government is expected to issue proposals this summer to strengthen the national law governing drug safety in the wake of alleged abuses of the current legislation by GlaxoSmithKline, producer of the antidepressant, Seroxat (paroxetine). Proposals to amend the UK law are being readied by the government with the help of the Medicines and Healthcare products Regulatory Agency (MHRA), which recently concluded a four-year investigation into whether GSK withheld certain clinical trial data pertaining to Seroxat.

The European Medicines Agency has decided that for the time being, there is no need to change the prescribing information for abacavir, a nucleoside reverse transcriptase inhibitor, which is used in combination with other antiviral medicines to treat patients with HIV. This follows the release of data from a large study which suggested that recent use of abacavir may be linked with an increased risk of myocardial infarction, the agency said in a press release issued on 2 April 2008.

The European Medicines Agency expects to see an increase in marketing-authorisation applications in 2008 after strong growth in 2007.

Regulatory agencies in both the UK and Belgium have started to review applications from pharmaceutical companies for exploratory clinical trials which are designed to generate information on the safety in man of new compounds before the traditional Phase 1 studies begin, according to speakers at a meeting of the Drug Information Association in Barcelona, Spain on 5 March 2008.

Advanced therapy medicinal products will be evaluated by a new scientific committee at the European Medicines Agency (EMEA) starting January 2009, according to Patrick Celis, scientific administrator of the agency.

The European system for regulating medicines may need to be fundamentally altered in the future in order to cope with the expected rise in marketing authorization applications for advanced therapies as well as applications for generic medicines, according to a panel of experts.

Four new medicinal products and four biosimilar products are being recommended for licensing in Europe by the European Medicines Agency (EMEA). The agency’s recommendations will be referred to the European Commission which has responsibility for issuing marketing authorisations.