Health canada_xml format

Implementation of the Canadian Labeling in XML format

April 4, 2018

Structured Product Monograph initiative in Health Canada

Asphalion_new office madrid

Asphalion expands their team of experts to Madrid

March 20, 2018

It is Asphalion’s second office in Spain, after the opening in Munich

medical device diagnostics

Update on the MDR/IVDR transitional period

March 15, 2018

Notified bodies and medical device manufacturers are facing many challenges until the full applicability of the new MDR and IVDR Regulations

nit catalonia bio 2018

Asphalion attended Nit de CataloniaBioHT 2018

March 9, 2018

As proud members of the association we attended the annual dinner

EMA Gateway

New release EMA Gateway version

March 8, 2018

The European Medicines Agency has released a new version of the Gateway (v3.4.0.0) with minor but significant additions/changes

rare disease day 2018

Rare Disease Day 2018

February 28, 2018

Asphalion is actively involved in numerous projects related to the investigation and treatment of rare diseases

ectd format

El formato eCTD ya está aquí!

February 2, 2018

¿Cuáles son las principales ventajas de eCTD sobre NeeS o el papel? ¿Cómo comienzo mi baseline? ¿Cuáles son las fechas de implementación? ¡Conoce todos los detalles de las eSubmissions obligatorias!

ectd format1

The eCTD format is already here!

February 1, 2018

What are the main advantages of eCTD over NeeS or paper? How do I start my baseline? What are the timelines?
Find out all the details of the mandatory electronic submissions!

myocure joel

Treating Rare Hereditary Muscle Disorders: MYOCURE Partner Interviews Provide Research Insights

January 29, 2018

Asphalion participates in the MYOCURE H2020 project as a regulatory partner


Team Asphalion is taking part in Oxfam Trailwalker

January 18, 2018

We want to share this challenge so that everybody can be part of our cause!
100 km, 1 cause – 14-15 April 2018, Girona

fda electronic submissions

Asphalion registered for electronic submissions to the Center for Veterinary Medicine of FDA

January 11, 2018

Asphalion is happy to announce that it has been registered by FDA to perform electronic submission to the CVM by the Gateway

new guidance

New steps to facilitate efficient generic drug review in FDA

January 10, 2018

New guidances help ANDA applicants avoid common deficiencies

ectd cep

In 2018, eCTD mandatory for new CEP applications

January 5, 2018

EDQM will stop accepting PDF submissions for revisions and renewal applications in 2018

nda and bla submissions

FDA may “Refuse to File” your NDA/BLA submission

January 4, 2018

New draft guideline clarifies the circumstances where an application can be “Refuse to File”

merry christmas 2017

Welcome 2018!

December 21, 2017

Wishing you a Happy Christmas and a prosperous New Year from all Asphalion team


4th Photo Contest Asphalion

December 19, 2017

Enjoy the most outstanding pictures included in Asphalion calendar for next year!


Asphalion in attendance as the nTrack H2020 project kicks-off in Barcelona

December 18, 2017

The four year Horizon 2020 nTrack project to develop nano-imaging reagents for stem cell tracking and biodistribution is now underway with Asphalion as regulatory partner.


CAMD Implementation Taskforce

December 7, 2017

Key issues to be addressed as part of the implementation of MDR and IVDR


Become an FDA expert! Join next Asphalion seminars on US Regulatory Affairs

November 28, 2017

23rd January 2018 in Munich & 7-8th June 2018 in Barcelona

New eudravigilance

The New EudraVigilance Human System is now live!

November 23, 2017

The system was launched yesterday with enhanced features for the reporting and analysis of adverse reactions

EU Agencies relocation

EU agencies relocation will be decided on 20th November 2017!

November 17, 2017

European Medicines Agency (EMA) and the European Banking Authority (EBA) are moving after Brexit

Global pharmaceutical regulatory affairs summmit 2017

Asphanews November 2017

November 17, 2017

Keep updated on the latest news of Asphalion and pharma sector!

Global pharmaceutical regulatory affairs summit 2017

Thank you for visiting us!

November 16, 2017

Thank you everyone for visiting Asphalion stands at CPhI 2017 in Frankfurt and GPRAS 2017 in Prague

Mdr in vitro

Notified Bodies re-designation under new Medical Device Regulation/In Vitro Diagnostics Regulation

November 14, 2017

26th November 2017 is the deadline for application


FDA has released tips on the submission of DMFs in eCTD format

November 11, 2017

As of 5th May 2018, Durg Master File submissions must be in eCTD format

ESGCT 2017

Asphalion reinforces its potential to support advanced therapy medicinal product (ATMP) development

November 10, 2017

The recent ESCGT meeting in Berlin highlighted the recent growth and commercial potential of advanced therapies as many products arrive to market. The EMA’s recent increased activity in this area also suggests that more might be on the way


Mandatory use of eCTD format in EU procedures

November 10, 2017

Maintenance activities of MRP registrations in eCTD will become compulsory in January 2018


IL3 course on Telematic management of drugs information

November 7, 2017

Remco Munnik is participating as a speaker presenting “Impact of the implementation of ISO-IDMP standards in the pharmaceutical industry”


HIVACAR and Asphalion attended Innovation Task Force (ITF) meeting with the EMA

October 27, 2017

Terapeutic strategy of the project and the clinical trial were discussed

general assembly meeting

Asphalion attends the first general assembly meeting (GAM) of the HIVACAR consortium in Paris

October 27, 2017

HIVACAR H2020 project aims to provide a new therapeutic alternative

scientific and technical advice meeting

Asphalion and HIVACAR attend scientific and technical advice meeting with Belgian national competent authorities AFMPS/FAGG

October 27, 2017

The aim of the meeting was to support the planned Clinical Trial Application