News Archive

Romanian ANMDM joins CESP - Update from June 12, 2014

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The Romanian National Agency for Medicines and Medical Devices (ANMDM) has joined the Common European Submission Platform (CESP) system as announced on June 02 by CESP.


EMA updates dossier requirements for centrally authorised human medicinal products


The European Medicines Agency has released a further update of the "Dossier requirements for centrally authorised products". As part of the update the new revision 8,...[more]

FDA ESG provides new WebTrader Hosted Solution as alternative to the ESG

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The US FDA has recently notified users of the Electronic Submissions Gateway (ESG) of a new capability which will be available starting June 01, 2014 - The WebTrader Hosted...[more]

French ANSM launches step III of it's CESP pilot phase

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The French drug regulatory agency ANSM has recently announced to lauch step III of it's CESP pilot program. As communicated earlier the ANSM took a stepwise approach to accept...[more]

CMDh clarifies numbering of eCTD sequences for MRP/DCP lifecycle

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The CMDh clarifies the correct numbering of eCTD sequences for applicants of EU MRP/DCP dossiers in case eCTD applications should have failed technical validation or content...[more]

New version of the eAF Data Exchange Standards released

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New versions of the Date Exchange Standards (DES) for the electronic Application Forms (eAF), dated 5 May 2014, have been released on the EMA eSubmission website. The DES was...[more]

Updated Q&A, defects and workaround solutions, Hotfix for eAF released

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A new hotfix version for the electronic Application forms

Marketing Authorization Application - HumanMarketing Authorization Application - VeterinaryVariation

has been...[more]

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