MoCRA: FDA provides update on upcoming launch of electronic submission portal

MoCRA: FDA provides update on upcoming launch of electronic submission portal

As previously reported, the submission of information about existing facilities who are marketing cosmetic produscts in the US, and listing of their cosmetic products according to MoCRA will be required from 29^th December 2023. The FDA is about to set up an electronic portal (“CDER Direct”) for this purpose. However, as of November 3, only the start page is available. The launch was originally announced for October 2023.

On November 1, 2023, the FDA announced on its website that further information on the launch of the electronic submission portal and paper submission forms will be provided “in the coming weeks“.

At the same time, the electronic submission route is strongly recommended by the FDA to facilitate the processing of submitted data. The industry is also advised to continue preparing for facility registration and product listing with the help of the documents already provided (e.g. the draft guidance) and to proactively reviewing and collecting the relevant information.

The deadline for facility registration and product listing remains December 29, 2023 (status: November 3, 2023).