The German Federal Institute of Drugs and Medical Devices (BfArM) has released a new version of the eSubmission validation software "eValidator" (by Lorenz,...[mehr]
The Portuguese Drug Regulatory Agency INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P) has recently released the national eSubmission roadmap for Portugal....[mehr]
The French Drug Regulatory Agency Afssaps has released a new version (Revision May 2010) of their national "Notice to Applicants for Marketing Authorisations for Medicinal...[mehr]
The Austrian Drug Regulatory Agency BASG has released an update of their Frequently Asked Questions (FAQ) website regarding electronic submissions. In summary, the newly released...[mehr]
A new version of the BfArM "eValidator" (basic edition, by Lorenz, www.lorenz.cc) is available for download from the BfArM website. The new version 3.0 SP1 HF4 includes...[mehr]
The German Federal Institute for Drugs and Medical Devices has informed the industry and stakeholders about the two most common experienced mistakes done by applicants submitting...[mehr]
The German Federal Institute for Drugs and Medical Devices (BfArM) has released a new "Step by step Guide on e-only submission at BfArM" on the e-submission website...[mehr]
