Pharmaceuticals
French data protection authority (CNIL) publishes reference methods for health data processing
16 August 2018 - Posted by: Laurie-Anne Ancenys
On 16 July 2018, the French Data Protection Authority (CNIL) published revised and new reference methods (MRs) regarding data processing in health research to adapt the existing framework to the EU General Data Protection Regulation (GDPR) and the national health data system (SNDS). Specifically, the CNIL updated: MR-001 on interventional research. MR-003 on non-interventional research. It also › Read More
The Netherlands: New borderline products advisory group established
14 August 2018 - Posted by: Iradj Nazaryar
On 9 July 2018, the establishment of the new Advisory Group on the Determination of the Status of Borderline Products was published in the Dutch Government Gazette. The Advisory Group consists of expert representatives from the Healthcare and Youth Inspectorate, the Dutch Food and Consumer Product Safety Authority, the Medicines Evaluation Board and the Central Committee › Read More
10 August 2018 - Posted by: Eveline Van Keymeulen
The eighth meeting of the Strategic Council for the Healthcare Industries (CSIS), between the French government and representatives of the healthcare industry, took place on 10 July 2018. The CSIS agreed on certain measures as part of a long-term roadmap to help France regain its attractiveness as an international centre of health innovation and excellence. › Read More
08 August 2018 - Posted by: Anna-Maria Withagen
Supplementary protection mechanisms have succeeded in achieving most of their aimed objectives, according to a study by the Technopolis Group that was commissioned by the Dutch government. However, another conclusion of the study is that the mechanisms seem to have various unintended effects as well. These effects still have to be further investigated. Below is › Read More
European Medicines Agency suspends clinical data publication
06 August 2018 - Posted by: Jacqueline Bore
The European Medicines Agency (EMA) announced on 1 August 2018 that, as part of its Brexit business continuity plan, it is temporarily suspending the publication of clinical data submitted to it as part of marketing authorisation applications. Data packages submitted before the end of July 2018 will be processed and formalised but no new procedures will › Read More