by chuck_ltd | 7 Mar, 2017 | CHCUK News & Articles, EAP, Orphan Drugs, Rare Diseases, Real Word Evidence
PRIME (PRIority MEdicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of...
by chuck_ltd | 19 Jan, 2017 | CHCUK News & Articles, Cures Act, EAP, News
The landmark 21st Century Cures Act[1] (“Cures Act”), which was signed into law by President Obama and became effective on December 13, 2016 (“Enactment Date”), imposes a deadline by which the manufacturer or distributor of an investigational...
by chuck_ltd | 7 May, 2014 | EAP
MHRA guidance on the supply of unlicensed medicinal products (‘specials’) better known as MHRA Guidance Note 14 has been updated. This guidance has been updated following the consolidation of medicines legislation into the Human Medicines Regulations 2012...
by chuck_ltd | 20 Mar, 2014 | EAP
The European Medicines Agency (EMA) is inviting companies to participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as...
