Working in Centralised Procedures?

February 16, 2016

EMA is requesting Marketing Authorisation Holders and Drug Substance manufacturers (ASMF Holders) to use the full life cycle possibilities of eCTD.

EudraCT the new version is now fully operational

February 2, 2016

EMA is now proposing a tight timeline of 6 months in which clinical trial results have to be entered into the system.

OPEN SEMINAR 2016: FDA Road to Success

January 7, 2016

Your seminar to become an expert in FDA Regulatory Affairs and eSubmission! Save the date! 9-10th March’16, Munich (Germany)

PRIME Scheme

December 22, 2015

As part of the European Medicines Agency strategy to reinforce regulatory support and improve timely access to medicines, a new scheme will be launched in Q1 2016 to further support development of new medicines addressing major public health needs.

Latest news from eAF

December 22, 2015

The use of the electronic Application Form (eAF) is going to be mandatory.

Changes with the report to the art 57 database

December 21, 2015

The EMA management board has released a communication that from 1 February 2016

Asphalion is looking for partners like you!

December 17, 2015

If you have a project that falls under the eligibility criteria for Horizon 2020 Programme, Asphalion is available to provide you with our regulatory expertise.

Asphalion contributes in recovery Nepal after the earthquake of April 15

December 16, 2015

We are very pleased to have participated in this charity project where the main objective has been to help recover Nepal after the earthquake in April 2015.

Latest news from the ISO IDMP S(ubstance)&P(roduct) meeting at EMA

December 4, 2015

The phased wise implementation of ISO IDMP will probably mean first submission of data end 2017 or 2018.
However, this is depending on the finalisation of the ISO standards


October 25, 2015

The European Commission and Heads of Medicines Agency have agreed with the phased wise implementation of ISO IDMP.

September 29, 2015

Would you like to know what they agreed?
Our Regulatory Information Director, Remco Munnik, attended the IWG group meeting on ISO IDMP at EMA.

Asphalion and Mitelos invite you to attend the first seminar in US

September 25, 2015

With more than 20 years of experience in the European regulatory environment, our speakers will present the important steps for setting the strategy for successful European submissions.

Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance

September 23, 2015

Last July EMA started a pilot phase to provide MAH’s a new service of medical literature searches (mandatory task for authorized products, according to pharmacovigilance legislation).

Transparency EMA

September 23, 2015

Starting this autumn, the EMA will ask CPs Applicants to send clinical information from your registration dossier eCTD format. These new requirements are part of the Transparency Policy (Policy/0070).

Asphalion’s article published this summer in BioScience Journal

September 22, 2015

“Biosimilars – What are the critical regulatory milestones during development and registration?”

Asphalion participates at European pharmaceutical regulatory environment seminar from EUCRAF

September 16, 2015

EUCRAF provides the opportunity of a specialized education in the area of biopharmaceutical-related regulatory affairs

CESP version 2.0 which will be released on the 1st October 2015

September 15, 2015

This new version incorporates new characteristics that answer directly to industry.

Upcoming training: “Pharmacovigilance, back to basics Masterclass”

September 14, 2015

The complete course presents the regulatory environment for the pharmaceutical industry along with numerous directives, regulations and guidelines.

What’s New in eSubmission?

July 24, 2015

The eCTD EU Module 1 v3.0 has been released for public consultation.

FDA: Increase of eCTD submissions of DMF

July 3, 2015

FDA presented the number of eCTD applications for Drug Master Files

Our team attended the eRA 2015 eRegulatory Affairs Conference (01-02 July 2015, Munich, DE)

June 29, 2015

Next Generation of Regulatory Information Management was the motto of eRA 2015.

Compliance with Pharmacovigilance legislation

June 26, 2015

Check our video to know everything you have to do before July 21st 2015!

AsphaNews – Special Edition FDA

June 26, 2015

Read about the latest news regarding the FDA

Quality control of Article 57 data: electronic notifications

June 25, 2015

EMA offers Gateway user organisations the possibility to test the receipt of the 3rd acknowledgment in the External Compliance Testing environment as of 1 July 2015

Our Regulatory Information Director attended the EU ISO IDMP Task Force meeting

June 19, 2015

ISO IDMP must be implemented before July 2016.

eCTD news

June 12, 2015

Be informed of the upcoming critical regulatory changes on the next two months in Europe and FDA.

EMA publishes updates to product information templates for all medicines for human use

June 11, 2015

Changes will enhance presentation of information for patients and healthcare professionals

AsphaNews June 2015

June 9, 2015

Read about the latest developments in the dynamic world of Drug Development, Regulatory Affairs and PhV.

EMA released dedicated webpage for ISO IDMP

June 9, 2015

The Agency and the EU Regulatory Network are pursuing an open dialogue with industry to discuss aspects of implementing the ISO IDMP standards in the EU.