Regulatory Open Forum

 View Only

  • 1.  Regarding Facility registration as per MoCRA requirements.

    Posted 13-Aug-2023 09:02
      |   view attached
    Hi all,
    As the FDA has released a Draft guidelines regarding Cosmetic registration (draft attached) does anyone know when will the FDA open the site for Facility and Product registration as per the MoCRA requirements? What will be the site url?
    Kind regards,
    Winston Costa Pereira.


  • 2.  RE: Regarding Facility registration as per MoCRA requirements.

    Posted 13-Aug-2023 12:48

    I see comments on that draft guidance are due within a month, and they're planning the site's user acceptance testing in September, so if they don't find too many things that need fixing, it might be finalized soon.

    https://www.federalregister.gov/documents/2023/08/08/2023-16772/pilot-program-for-cosmetic-product-facility-registration-and-listing-electronic-submissions-user



    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------

    Original Message


  • 3.  RE: Regarding Facility registration as per MoCRA requirements.

    Posted 14-Aug-2023 09:19

    In line with Anne's comment - the FDA is working towards making the portal available in October 2023, and has a request out for voluntary participation in a pilot program to evaluate the portal - with interested parties asked to apply by 22 August 2023. The pilot program will run for two weeks (beginning in September) but will not count towards the organization's fulfillment of registration requirements and responsibilities under MoCRA.



    ------------------------------
    Buki Forteau
    Lead, Global Regulatory Intelligence Program
    Roswell GA
    ------------------------------

    Original Message


  • 4.  RE: Regarding Facility registration as per MoCRA requirements.

    This message was posted by a user wishing to remain anonymous
    Posted 14-Aug-2023 15:17
    This message was posted by a user wishing to remain anonymous

    Hi,

    The draft guidance mentions that FDA intends to make the new electronic submission portal available for submitting registration and product listing information under section 607 of the FD&C Act in October 2023.


    Original Message


  • 5.  RE: Regarding Facility registration as per MoCRA requirements.

    Posted 18-Sep-2023 17:10

    Hi folks.

    In case you didn't see this today - FDA released screenshots of the newly planned web portal (still undergoing beta testing) as well as draft paper forms in the event these are necessary.  You can find more information here: FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products | FDA

    Right at the top of the page are hotlinks to the web portal screenshots (not the greatest clarity but this is better than nothing!) as well as draft paper forms.  The paper forms are separate for facility registration and product listing and there are some obvious improvements that might be suggested for the paper product listing form (especially the fact that the form only allows for a total of 3 products or shades per form!) but these will provide you with visibility into the exact types of information that we will be required to provide.  Also, check the guidance carefully because the "product codes" are listed in Appendix A at the end!



    ------------------------------
    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
    ------------------------------

    Original Message


Related Content