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

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

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

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.

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

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

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.

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.

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

It will be applicable as of February 9, 2019

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

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.

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).

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).

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

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

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

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

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

The PcV fee is charged for each Chargeable Unit (CU)

FDA presented the number of eCTD applications for Drug Master Files

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

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

Read about the latest news regarding the FDA

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

ISO IDMP must be implemented before July 2016.

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

Changes will enhance presentation of information for patients and healthcare professionals

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

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.

08 June 2015 – Register Now!