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]

French Afssaps issues new version of their national Notice to Applicants

The French Drug Regulatory Agency Afssaps has released an updated version of their national "NOTICE TO APPLICANTS FOR MARKETING AUTHORISATIONS FOR MEDICINAL PRODUCTS FOR...[more]

BE: Update of the national eSubmission Guideline and corresponding NeeS checker

The Belgian Federal Agency for Medicines and Health Products (FAGG) has released an updated version 2.11 of the national eSubmission Guideline applicable for electronic...[more]

Updated national eSubmission guidance for Spain released

The Spanish Medicines Agency AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) has releases and updated version 2.1 of their national eSubmission guidance...[more]

Belgian FAGG revokes previously released bug fixed version 2.9.b of the NeeS checker

The Belgian Federal Agency for Medicines and Health Products (FAGG) has revoke the previously released version v.2.9.b (see our related News Article from September) of the...[more]

Belgian FAGG releases bug fixed version 2.9.b of the NeeS checker

Update! Please note that the information below is outdated. Meanwhile, the version v.2.9.b of the NeeS checker has been revoked by the FAGG. See our related News Article from...[more]

BE: New version of eSubmission Guideline released by FAHMP

The Belgian Federal Agency for Medicines and Health Products (FAHMP) has released a new version of their national "eSubmission Guidelines" document, version 2.10 which...[more]