Pharmaceutical News and Updates

Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines

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…

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…

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…

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…

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…

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…