Tag Archives | EU


German RECs Seek to Simplify NIS Approval

Germany – Professional Advice under Section 15 BO Ärzte: Speeding up the Process for Non-Interventional Studies? Author: Mark Heinemann, Principal Regulatory Advisor, CHCUK Consulting German Ethics Committees (ECs) make an important step towards the simplification of the ethical evaluation of Non-Interventional Studies (NIS). A number of University and State Medical Association Ethics Committees take part […]

Continue Reading

6th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology – July 2017

The 6th revision of the ENCePP Methods Guide is now available on the ENCePP website and includes revisions, amendments and new references in all the chapters. Revisions were performed by the authors, in collaboration with the editorial group. External comments received were also considered. Due to developments in some areas or need for restructuring and […]

Continue Reading

How far do the medical device rules affect health-related apps?

Source: Osborne Clarke It is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its marketing.  But deciding exactly when software will be categorised as such a device is not so straightforward.  An Opinion from an Advocate General […]

Continue Reading

RWE – What are the Opportunities across the product life cycle?

What are the real-world evidence tools and how can they support decision making? EMA-EuropaBio Info Day – 22nd November 2016 Dr Alison Cave, Principal Scientific Administrator, Pharmacovigilance and Epidemiology Department, EMA [View Slide Deck…] RWE – What are the Opportunities across the product life cycle? Medicines Development Population-based databases to characterize frequency and distribution of […]

Continue Reading

EU – List of Products Granted Eligibility to PRIME

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 promising medicines, to optimise development plans and speed up evaluation so these medicines can […]

Continue Reading

Germany – Impact of Amendment of the German Drug Act on NIS

The German Bundestag adopts Fourth Act on the Amendment of the German Drug Act and Other Provisions Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health The 4th law on the amendment of the German Drug Act came into force on December 24, 2016 (G. v. 20.12.2016 BGBl. I S. 3048 (Nr. 63)). […]

Continue Reading

Portugal: Changes in the legal framework of advertising of medicines and medical devices

Rules that govern advertising and promotion activities of medicines and medical devices in Portugal have been changed recently by the enactment of Decree-Law 5/2017 of 6 January (“Decree-Law 5/2017”). This new legal act establishes principles that shall be accomplished by marketing authorization holders and distributors of medicines, as well as manufacturers and distributors of medical […]

Continue Reading