News Archiv

DK: DKMA going to accept electronic-only submissions from Jan-2010

The Danish Drug Regulatory Agency DKMA announced their acceptance of electronic-only submissions from January 2010 on.

Medicinal Products for Human Use

Submissions concerning...[more]

IE: IMB released the final version of their guide on electronic submissions for human medicines

Ireland now joined the significantly increasing group of EU Member States for which national requirements on electronic submissions have been published.

The Irish Medicines...[more]

NO: NoMA ready to accept eCTD from Jan 2010

The Norwegian Medicines Agency (NoMA) recently accounced their acceptance of electronic submissions from January 2010 on. From this date onwards it will not be required to submit...[more]

ES: AGEMED puplishes an adapted national version of the NeeS guideline

An adapted national version of the NeeS guideline has been published by AGEMED, the Spanish national drug regulatory agency.

It is available in Spanish language from...[more]

BE: FAGG publishes updated version of e-Submission guidance

[Source: FAGG website][more]

UK: MHRA publishes update of FAQ´s to Special Mail 5

This new version of the Special Mail 5 (SM5) FAQ contains minor amendments to the SM5 FAQs v2.0. The minor amendments have been highlighted in pink in the FAQ document...[more]

BE: New version of the "eCTD checker" (2.6a) published by FAGG

Starting from 8 may 2009, all submissions uploaded within the internal IT system of the Belgian Drug Regulatory Agency FAMHP, will be technically validated using their updated...[more]