Pharmaceutical News and Updates

More on Adaptive Licensing (AL)

There is currently much debate about adaptive pathways for new medicinal products to come to the market. The terms ’staggered approval’, ’progressive licensing’, and ’adaptive licensing’ have been used, often interchangeably, to describe the same broad concept. More recently, the term ‘Medicines Adaptive Pathways’ (MAPs) or ‘Medicines Adaptive Pathways…

Adaptive Licensing

A Brief Summary of the new fast-track European procedure by Simon Ruini, Director of PhD London The Adaptive Licensing Pilot Project was launched by the EMA on 19 March 2014. This summary addresses some frequently asked questions and clarifies the terms of engagement and expected outputs for prospective applicants. 1. What is…

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…