Asphanews November 2017
FDA has released tips on the submission of DMFs in eCTD format
As of 5th May 2018, Drug Master File (DMF) submissions must be in eCTD format
AEMPS establishes recommendations for the implementation of safety devices in medicinal products for human use
It will be applicable as of 9th February, 2019
HIVACAR and Asphalion attended Innovation Task Force (ITF) meeting with the EMA
Food and Drug Administration Reauthorization Act (FDARA) includes four medical product user fee programs.
Notified Bodies re-designation under new Medical Device Regulation/In Vitro Diagnostics Regulation
26th November 2017 is the deadline for application
Mandatory use of eCTD format in EU procedures
Maintenance activities of MRP registrations in eCTD will become compulsory in January 2018
New version of the EMA EudraVigilance to be launched on 22nd November
Improved system with enhanced features for reporting and analysis of suspected adverse reactions related to medicines
Asphalion reinforces its potential to support advanced therapy medicinal product (ATMP) development
The recent ESCGT meeting in Berlin highlighted the recent growth and commercial potential of advanced therapies as many products are arriving to market. The EMA’s recent increased activity in this area also suggests that more might be on the way.
Visit Asphalion stand at the 1st European PhD and Postdoc symposium to know the opportunities the Regulatory affairs field can offer you!
The event is being held in Barcelona from the 15-17th November 2017