eCTD Industry Update (02 August 2022)

eSubmissions (eCTD)

The 1st DADI newsletter has been published on the EMA website

• The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of the DADI project.
• You can find the first issue of the newsletter here.

Presentation from the public webinar “DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live” held on 12th July 2022

• The presentation from the public webinar is now available.

CMDh

• UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines

MHRA

• Register medical devices to place on the market