From today, the European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation. This includes completing previously submitted information with additional data elements included in the new data-submission format, bringing medicine information up–to-date, and checking that the [read more…]
Archive for the ‘Pharmaceutical News’ Category
Monitoring of Patent Settlements in Europe
Patent settlement agreements are commercial agreements to settle patent-related disputes, e.g. questions of patent infringement or patent validity. They are concluded in the context of patent disputes, opposition procedures or litigation where no final adjudication has been handed down. Although the content of individual settlements will vary according to the circumstances of the case, [read more…]
End of Herbal Sell-through Period
The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding herbal companies and retailers that, as of 1st May 2014, unlicensed manufactured herbal medicines without a traditional herbal registration (THR) or product licence (PL) can no longer be sold to consumers and must be removed from shelves. Dr Linda Anderson, from the MHRA Licensing [read more…]
The 10 leading causes of death in the world (2014 update)
WHO has just published an interesting update to the leading causes of death. We pesent it in this article with some tables for ease of reading. The 10 leading causes of death in the world Ischaemic heart disease, stroke, lower respiratory infections and chronic obstructive lung disease have remained the top major killers during [read more…]
EMA and FDA meet on new initiatives
Senior leadership from DG Health and Consumers (European Commission), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) discussed a number of key initiatives at a bilateral meeting which took place in London from 31 March to 1 April 2014. These meetings take place approximately every 18 months. They [read more…]
Orphan Drugs and Ultra-orphan, NICE tries to find a balance.
Earlier this month the UK Bio-Industry Association published a report detailing their recommendations for the new ultra-orphan medicines evaluation framework for ultra-orphan drugs currently being developed by the UK’s Nation Institute for Health and Care Excellence (NICE). The report recognises that national regulators within the EU have failed to strike an appropriate balance between the [read more…]