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[EU] EMA: Scientific guideline: CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products , draft: consultation openThe European Medicines Agency have published: Scientific guideline: CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products , draft: consultation open [EU] EMA: Scientific guideline: Overview of comments received on 'Guideline on Clinical Investigation of Medicinal Products in the treatment of epileptic disorders' (CHMP/EWP/566/98 Rev.2)The European Medicines Agency have published: Scientific guideline: Overview of comments received on 'Guideline on Clinical Investigation of Medicinal Products in the treatment of epileptic disorders' (CHMP/EWP/566/98 Rev.2) [EU] EMA: Scientific guideline: CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products, draft: consultation openThe European Medicines Agency have published: Scientific guideline: CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products, draft: consultation open [EU] EMA: Scientific guideline: ICH topic E7: Studies in support of special sopulations: Geriatrics - Step 5The European Medicines Agency have published: Scientific guideline: ICH topic E7: Studies in support of special sopulations: Geriatrics - Step 5 [DK] Danish Medicines Agency: EMA reassesses cardiovascular safety of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim)In July, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) once again initiated a review of the benefit-risk profile of rosiglitazone-containing medicines, which in Denmark are used to a very limited degree for the treatment of type 2 diabetes. We remind doctors to pay strict attention to the restrictions appearing from the summaries of product characteristics for any medicine. The CHMP is expected to finalise its scientific review by September 2010. [UK] MHRA: Current advice and information about the use of rosiglitazone (Avandia, Avandamet▼) in the treatment of diabetesNew data have been published that raise concern about an increased risk of cardiovascular adverse effects of rosiglitazone. These data add substantially to existing evidence and point towards an increased cardiovascular risk with rosiglitazone compared with both placebo and with pioglitazone. [UK] MHRA: Shortages and supply chain obligations – Guidance for registered pharmacies that also hold wholesale dealer’s licencesIn November 2009, the MHRA together with the Department of Health and eight other bodies, published guidance on maintaining and protecting the supply chain. The MHRA has provided clarification on the guidance for registered pharmacies that also hold wholesale dealer’s licences. |
These European updates are some of the recent key regulatory news items we have noted, including those from the regulatory agencies and authorities in Europe. A two-letter code is used at the beginning of each item to indicate the country or region, according to the