Global pharmaceutical regulatory affairs summmit 2017

Asphanews November 2017

Asphanews November 2017: Keep updated on the latest news of Asphalion and pharma sector!

Asphanews November 2017: Keep updated on the latest news of Asphalion and pharma sector!
November 17, 2017

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

Search News & Events

  • Filter by category


Related news and events

Christmas season greatings

Season’s Greetings

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting