News Archiv

Exalon to speak on XEVMPD workshops organized by Lorenz Life Science Group

Dr. Michael Braun of Exalon will speak on several free XEVMPD workshops organized by one of our partners, the Lorenz Life Science Group.

Michael will give an overview...[more]

CMDh starts voluntary pilot phase for technical eCTD validations to be performed by RMS on behalf of CMS

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has published a new guidance document (Doc. Ref.: CMDh/253/2012) detailing the...[more]

FDA releases draft guidance for standardized study data

The U.S. Food and Drug Administration (FDA) has released a new draft guidance document "Providing Regulatory Submissions in Electronic Format — Standardized Study Data"....[more]

New draft version of technical EU eCTD/NeeS validation criteria released for consultation

The Telematics Implementation Group for electronic submissions (TIGes) has released new draft versions for public consultation of the EU technical validation criteria for eCTD...[more]

EMA informs stakeholders about reduced data requirements for XEVMPD

The European Medicines Agency informed stakeholders from the pharmaceutical industry about the proposed way forward to progress with the implementation of Article 57(2) of...[more]

CMDh releases new version of the cover template for new applications submitted through MRP/DCP

The Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released revision 3 of the cover letter template that should be used by applicants...[more]

UK MHRA details technical validation process for eCTDs

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has released some information regarding the technical validation of electronic Marketing Authorisation...[more]