AsphaNews June 2015

Learn about the most recent changes in the dynamic fields of drug development, regulatory affairs, and phenotypic virology.

Learn about the most recent changes in the dynamic fields of drug development, regulatory affairs, and phenotypic virology.
June 9, 2015

EMA held the Information Day on New Services and Systems in Pharmacovigilance: Preparing for Business Change

The main goal of this Information Day was to provide marketing authorisation holders (MAHs) with information to help preparing the upcoming business change, focusing on the most critical questions: what needs to be done and by when?

The topics addressed were mainly related to system and service development, with special emphasis on EudraVigilance: adverse drug reaction reporting and signal management, medical literature monitoring, database of medicinal products (Article 57) and pharmacovigilance fees, as well as the Periodic Safety Update Report (PSUR) Repository. This further includes an update on new or revised technical guidelines (non-GVP).

The main changes are:
Adverse reactions reporting changes to come:E2B (R2) format is going to change to E2B (R3):
  • EVWeb is going to be supported for Firefox and Chrome
  • By Q3/Q4 2015 Public Access to EVWeb data will be available to the public and HCPs, MAHs and NCAs.
  • Electronic Reaction Monitoring Reports (eRMR) will be the format to download case line-listings from the public access in order to help MAHs to fulfill their obligations regarding signal detection procedures.

Article 57 and how data can be used for PhV:

  • Before 30 June 2015, all medicinal product data in xEVMPD has to be updated, as it will be used for:
  • Calculation of MAH?s chargeable units for PhV fees
  • Reporting adverse reactions
  • PSUR repository
  • Medical Literature Monitoring services (MLM)
  • In a near future, changes in QPPV contact details and PSMF location are going to be communicated via Art. 57 and a variation procedure will not be necessary.

PhV fees:

  • EMA is starting to send advice notices with the information being used for calculation of fees.
  • Before 30 June 2015 MAHs are expected to correct all data in Art.57.
  • From 1st July 2015 EMA will start invoicing all chargeable units.
  • Legal basis and SME status are crucial data to get a fee reduction.

EMA Service of Medical Literature Monitoring (MLM) for reports of suspected adverse reactions:

  • In August 2015 MLM service is expected to be launched on production.
  • Webtrader users do not have to do any change in their profile
  • Gateway users will have to perform testing both in test and production environment.
FDA publishes guidelines for biosimilar
Since the first biosimilar approval in early March, FDA has prepared and released four guidance documents for industry:
FIMEA switches over to new financial and HR processes and information systems on 1 October 2015

The key changes resulting from this new system will be:

  • After 1st October, for Marketing Authorisation Applications and variation applications, advance payment will no longer be accepted
  • Annual fees for marketing authorisations will be sent to customers every year, approximately two months before the marketing authorisation grant date.
  • MAHs are asked to provide FIMEA with an invoicing address (only one), to which all invoices will be sent (MAAs, variation applications, annual fees, licence and inspection fees), before the 15th of June.
AEMPS implements new telematics system for the Pharmaceutical Product Certificate requests.
This new module belongs to the already existing application to request import authorization for human medicinal products.
This application will permit MAHs to manage their requests, including the Pharmaceutical Product Certificate requests, additional information requests and obtaining the referred certificate.
The system was launched the 1st of June and in order to access it MAHs will have to fill out a form and send it by post, after which the log in credentials will be sent by mail.


Complimentary Webinar: eCTD mandatory for DCP by 01 July 2015 – Are you ready for submitting your DCPs in eCTD Format?
08 June 2015 – Register Now!

ASPHALION and EXTEDO invite you to a complimentary webinar covering the topic of eCTD getting mandatory for the Decentralized Procedure (DCP) by 01 July 2015.

During the webinar our Regulatory Information Director, Remco Munnik, will provide you an update on the implementation of the eSubmission Roadmap with special focus on eCTD, eAF and Common Repository. After the theoretical part, Oliver Bosch (Application Support Specialist) will give you an overview how to create a Submission within EXTEDO´s eCTDmanager.


AsphaTeam: ASPHALION is happy to announce the new position of Ana Duarte as Business Development Officer.

Upcoming Events

1 – 2 July: eRA Conference
(Remco Munnik as speaker)Munich, DE
12 – 14 October: TOPRA Annual Symposium
Berlin, DE
13 – 15 October: CPhI  
Madrid, ES
For more information on the topics of this AsphaNews, please contact us at

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