Electronic Submission Portal for Cosmetics
Recommendation
23/24 October 2024
Requirements, Challenges & Solutions
The U.S. FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). According to the agency, Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. This will help the applicant organize their registration and listing submission to include the information needed for FDA and will give access to the previous Cosmetic Direct registrations and listing submissions.
FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. However, applicants that prefer to submit paper registrations and listings will still have the option to do so. Draft screenshots of the electronic system are available below for review and comments:
- Draft Cosmetics Direct Electronic Submissions Portal
- Draft FDA Form 5066 -Registration of Product Facility
- Draft FDA Form 5067 - Cosmetic Product Listing
For more information please see the Registration and Listing of Cosmetic Product Facilities and Products View on the FDA Website.
Related GMP News
26.06.202410 points on how the FDA's CDER monitors the Quality of Medicinal Products
08.05.2024EMA Plans for the next three Years
30.04.2024Lean GMP: is "right-sizing" GMP and Compliance possible?
24.04.2024Unexpected Deviations: the Role of the QP
10.04.2024FDA's current Thinking on KPIs and Quality Metrics
21.02.2024What is the African Medicines Agency?