The Food and Drug Administration (FDA) is mandated to issue standards and appropriate marketing authorizations (MAs) to all its covered establishments, facilities, and health products. Through this endeavor, the FDA streamlined its processes through the establishment of various online application platforms for the issuance of MAs including License to Operate (LTO) for Manufacturers, Distributors, Traders, Drug Outlets, Retailers, Clinical Research Organizations, and other health establishments as determined by the FDA. Relative to this, the FDA drafted an Administrative Order entitled, “Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration” which aim to reengineer and automate the FDA’s processes for initial, renewal, and variation of LTO.
In the interest of service and to seek the inputs of stakeholders that will be affected by the above-mentioned proposed policy, the FDA is respectfully inviting one (1) representative of each company/ organization from the health industry to attend the Public Hearing to be scheduled on the following dates at the FDA Conference Hall, Civic Drive, Filinvest, Alabang, Muntinlupa City:
|
Target Participant |
Type of Health Product | FDA Resource Speaker | Date/Time |
| 1. Manufacturer
2. Trader 3. Distributor (Wholesaler, Importer, Exporter) 4. Drug Outlets – Drugstores – Pharmacies – Retail Outlet for Non-Prescription Drugs 5. Clinical Research Organizations and Sponsors
|
· Drug products for human use
· Biological drug products · Radiopharmaceuticals and precursors · Advance therapy drug products · Homeopathic products · Medical gases · Herbal and traditional medicines · Orphan drugs · Animal health products · Other drug products |
CDRR & FDA
INSPECTORATE
|
04 July 2023
9:00 AM – 12:00 PM Tuesday |
| 1. Manufacturer
2. Trader 3. Distributor (Wholesaler, Importer, Exporter) 4. Retailers of Medical Devices
|
· Medical devices
· Radiation-emitting devices · In-vitro diagnostic devices and reagents · Refurbished medical devices · Custom-made medical devices · Equipment or devices used for treating sharps, pathological, and infectious wastes · Water treatment devices/systems · Other health-related devices |
CDRRHR & FDA
INSPECTORATE |
04 July 2023
1:30 PM – 4:30 PM Tuesday |
| 1. Manufacturer
2. Trader 3. Distributor (Wholesaler, Importer, Exporter)
|
· Cosmetic products
· Household/urban pesticides · Toys and childcare articles · Other cosmetic products |
CCHUHSRR & FDA
INSPECTORATE |
05 July 2023
9:00 AM – 12:00 PM Wednesday |
| 1. Manufacturer
2. Trader 3. Distributor (Wholesaler, Importer, Exporter)
|
· Processed food products
· Food/dietary supplements · Raw materials, ingredients, and additives for food · Other food products |
CFRR & FDA
INSPECTORATE |
05 July 2023
1:30 PM – 4:30 PM Wednesday |
|
1. Micro, Small, and Medium Enterprises 2. Industry Associations 3. Government-Agencies 4. Concerned/Interest Groups 5. Other identified stakeholders |
|
The Public Consultation is on a first-come, first-served basis and we have allotted fifty (50) slots in each schedule. The FDA will restrict the registration link access once we already receive the allotted number of participants to attend the public consultation. Registration is through this link: https://forms.office.com/r/NUSx0U7cNy .
For those who are not registered, you may send an e-mail to the FDA-Policy and Planning Service at [email protected] signifying your interest to participate by following the below subject title:
“FDA-LTO PUBCON [Name of Organization/Company/Association/Government Agency] [FDA-CONCERNED CENTER (e.g. CDRRHR)]”
Further, provided herewith a copy of the draft Administrative Order. You may provide the comments prior the scheduled public consultation and send it to [email protected] not later than 30 June 2023.
Thank you very much.