The Philippine FDA Reiterates the Mandatory Implementation of One ASEAN Regulation

Nanomaterials Cosmetics Bottle Cream Regulation
The FDA Philippines provides information on the ASEAN Cosmetic Directive’s pre-and post-marketing regulatory processes, such as Cosmetic Notification and the Cosmetic Product Information File (PIF), among others.
The PIF is a document containing the technical and safety information of the cosmetic product. CF No. 2018-001 specifies the list of documents that must be part of the PIF, as shown below:
  • Part I: Administrative Documents and Product Summary
  • Part II: Quality Data of Raw Material
  • Part III: Quality Data of Finished Product
  • Part IV: Safety and Efficacy Data

Moreover, the FDA reiterates the following responsibilities of the Marketing Authorisation Holder (MAH):

  1. The MAH or the “Company Responsible for Placing the Product in the Market” who has notified a cosmetic product to FDA shall keep and maintain an updated PIF
  2. Every cosmetic product duty notified to FDA shall have a corresponding PIF
  3. The MAH shall follow the PIF format as stipulated in CF No. 2018-001
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