News Archiv

EU: Presentations from TIGes Veterinary eSubmission workshop posted

Information material from the last TIGEs Veterinary eSubmission workshop from 04-Dec-2009 has been posted. The material consists of

Presentation from Dr. Michael Colmorgen...[more]

US: RPS Rel 2 schema and DSTU agenda and material posted by HL7

RPS release 2 schema files and the DSTU (Draft Standard for Trial USE) agenda and additional material have been posted on the HL7 wiki/Regulated Product Submission...[more]

DE: BfArM publishes announcement regarding electronic-only submissions

!Updated 01-Mar-2010!

Today the German drug regulatory agency BfArM published an announcement detailing the plans for accepting electronic-only submissions for medicinal products...[more]

EU: Updates for PIM released by EMA

Some updates regarding PIM (Product Information Management) have been posted on the EMA website today.

The DES (Data Exchange Standard) version status informaton has been...[more]

EU: Updated explanatory notes on variation application form and implementation table for NPs

The CMD(h) together with the EMA released an updated revision 1 of the "Explanatory Notes on the Variation Applicaton Form (Human Medicinal Products)" which...[more]

Event: New Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of DDI

An international Workshop on "New Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions" will...[more]

EU: CMD(h) publishes updated requirements on electronic submissions

A new version of the requirements on electronic submissions for new applications within MRP, DCP or National procedures in EU is available from the Heads of Medicines Agency (HMA)...[more]