Health informatics – IDMP – Implementation guidelines for ISO 11238

By | Blog | No Comments

While the EMA is currently busy moving to the Netherlands and while the IDMP project currently seems to go slow, there is definite and significant progress being made in the background. The latest achievement is a major overhaul of the ISO/TS 19844 “Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances”. Read More

eCTD Health Canada – an overview

By | Blog | No Comments

eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format will be accepted throughout the marketing authorisation of drugs. One of the regions announcing eCTD as a mandatory format to be used for drug applications is Health Canada. Read More