News in brief
Final approval has been given to the proposed EU herbal medicines directive by the European Parliament, which amended the text slightly in its second reading. MEPs insisted herbal products already registered as food (hence falling under food regulations) should maintain this status. The directive should cover only 'the medicinal use of herbal substances'.
EMEA's committee for proprietary medicinal products (CPMP) has re-elected Dr Daniel Brasseur as its chairman and Dr Eric Abadie as vice-chairman. The decision came at the CPMP's 100th meeting, where EMEA executive director Thomas Loenngren said: 'The CPMP has established itself over the past years as a premier scientific body, not just in Europe but internationally.'
Interpol is to stage an international meeting of police and experts to discuss ways of fighting the growing international traffic in illegal sports performance-enhancing drugs. The agency is particularly keen to collate more information about the problem for its databases, which can be accessed by police forces worldwide. A planned international working group is to be convened before mid 2004 to chart a plan to fight sports-drug trafficking, working with sporting federations and funding sponsors.
Advice has been released by EMEA on the impact of May's EU enlargement on new marketing applications for orphan drugs. It also addresses the effect on existing designations, translations and transitional arrangements for the period before May.(see below for link)
A US FDA advisory committee has said that the regulator should issue stronger warnings to doctors about the possible link between antidepressants and suicidal thoughts among young people. These warnings should not discourage doctors from using such antidepressants, but alert them to signals that a drug might be having harmful effects, said the committee.
An Oman Pharmaceutical Products Company (OPPC) has been launched to produce and market medicines for diabetes, cardiac disease and other illnesses under the Synova brand. Oman's royal government holds a major stake in the US$50m company. Oman currently imports most of its pharmaceutical products.
Swiss pharmaceutical group Helsinn Healthcare has granted Italfarmaco the exclusive license and distribution rights for palonosetron (Onicit) in Spain. Palonosetron is a potent, highly selective 5-HT3 receptor antagonist for the treatment of chemotherapy-induced nausea and vomiting (CINV). It is commercialised in the US under the tradename Alox by MGI Pharma, while in Europe the product is under regulatory review and will be marketed under the tradename Onicit.