News

Last weeks round-up; 20 – 24 January 2020

published 28 Jan 2020

NEW REAL REPORT: EUROPEAN REGULATORY LANDSCAPE 2020

2020 will see changes to all regulatory landscapes including Clinical Trials, Medical Devices and Chemistry and Manufacturing Controls changes, with the hopes of implementing a robust and effective regulatory network. The focus is on the New Medical Device Directive and the Clinical Trial Regulations which are designed to keep current with technological and medical advances and help ensure safe and effective medicines and medical devices are delivered to patients. For more information, please see the following link: https://lnkd.in/dcf–H6

EMA AND HMA PROPOSES TEN RECOMMENDATION TO UNLOCK THE POTENTIAL OF BIG DATA FOR PUBLIC HEALTH IN THE EU

The joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposes ten priority actions for the European medicines regulatory network to evolve its approach to data use and evidence generation, in order to make best use of big data to support innovation and public health, in a report published 20th Jan 2020. Further details and a pdf of the report can be found here; https://lnkd.in/dB2Czi9

EMA REFLECTION PAPER ON GOOD MANUFACTURING PRACTICE (GMP) AND MARKETING AUTHORISATION HOLDERS (MAHS)

In general, the responsibilities for MAHs relate to outsourcing and technical agreements, that require the MAH to perform certain specific tasks (e.g. evaluating the results of product quality reviews, agreeing irradiation cycles with manufacturers, etc.). These responsibilities are spread over the various chapters and annexes of the GMP guide, and are quite numerous. Further specific details can be found under the link below; https://lnkd.in/dGJb34u