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 | 6 Jan, 2017 | Biosimilars, CHCUK News & Articles
Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes and 16 biosimilar applications, including...
by chuck_ltd | 22 Dec, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News, Publication Guidelines
On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use...
by chuck_ltd | 17 Aug, 2016 | Biosimilars, CHCUK News & Articles, News
Guideline on Good Pharmacovigilance Practices (GVP). Product- or Population-Specific Considerations II: Biological Medicinal Products The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, GVP, News, NIS, Real Word Evidence
Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 2) Date for coming into effect of Revision 2 – 9 August 2016 Revision 2 contains the following: Changes to VIII.A., clarifying the link between the...