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....[more]
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...[more]
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...[more]
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...[more]
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...[more]
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...[more]
The Federal Agency for Medicines and Health Products in Belgium (FAHMP) has relased a new version 2.9 of their national "eSubmission Guideline" (the previous...[more]
