Products in the Philippines Regulated by BFAD
Posted on June 29th, 2009
Based on Republic Act 3720 entitled “Food, Drug and Cosmetic Act,†the Bureau of Food and Drugs (BFAD) has the authority to regulate drugs, cosmetics, processed food and household hazardous substances.
In order to easily determine the applicable documentary requirements for presenting applications for establishment licensing or product registration, a classification of product is used. The classifications of products are based on product classes, categories and type like in the Table of Products.
In order to apply for License to Operate (LTO), the applicant would have to undergo the following processes:
• Application to BFAD of the establishment owner for the renewal or amendment of a License to Operate.
• Payment of the equivalent processing fees
• Then, BFAD will process the application. Evaluation will be made before a decision on the application is made in order to determine if the applicants should be issued an LTO.
• If approved, BFAD will issue the LTO.
With the continuous growth of technology, it is now possible for the Submission of application be made online through the BFAD Integrated Information System (BIIS). Through the BIIS, even the payment, processing and issuance of the LTO can also be made through online.
Service Description and Division
The services performed by the Laboratory Services Division (LSD) are the following:
• They are assigned to do laboratory testing of finished products to identify if it is complying with the standards of safety, efficacy, purity and quality
• It is also their responsibility to do testing on the materials for packaging that was used for foods, cosmetics, drugs, medical apparatus and other products related to it.
• Establishment of scientific data base that can be used in developing standards of products
• For toxicological examinations, bioassay and biological research and development, LSD produces properly bred laboratory animals.
• Inspecting and auditing for BFAD-LSD to recognize analytical laboratories
• Providing and conducting training in the different Centers for Health Development mini laboratory for the Regional FDRO.
