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Regulatory Pharmacist: registering and testing of new medicines and drug therapies being developed by government or private pharmaceutical

cal companies compile data, prepare reports and make presentations to governing bodies regarding the tests and clinical trials that have been completed on the drug ability to interpret test results, analyze data and make recommendations is very important. Management skills in working with research groups and outside stakeholders an investors is an asset

Questions on Product Registration with BFAD How do we know whether our product will be classified by BFAD as food, drugs, or cosmetics? Clients may apply for product classification at BFAD. Application documents with sample and complete product information and proof of payment may be submitted at the Policy, Planning, and Advocacy Division - Public Assistance and Compliance Division (PPADPAICS), Room 101.

How do we register our products? A local company in the Philippines must secure a License to Operate (LTO) from BFAD before applying for product registration. All issuances and guidelines, checklists of requirements, and forms pertaining to licensing of establishments and product registration may be downloaded from the BFAD Website: http://www.bfad.gov.ph.

How much is the processing fee for licensing or product registration? Fees are listed in Administrative Order No. 50 s. 2001: Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs. This is available thru http://www.bfad.gov.ph/AO/ao 50 2001.pdf.

We need to conduct a specific test analysis for our products. How can we have our products tested? Clients may access the BFAD Website for the list of recognized laboratories (http://www.bfad.gov.ph/laboratories_modified.htm). The list contains the addresses, contact numbers, and types of analysis offered by the laboratories.

What types of establishments are required to apply for a License to Operate with BFAD? Establishments involved in the manufacture, packaging, re-packaging, importation, exportation, distribution, and retailing of processed foods, drugs, medical devices, in vitro diagnostic reagents, cosmetics, and household hazardous substance products must secure a License to Operate from BFAD.

What types of products are registered with BFAD?

BFAD handles the registration of processed foods, drugs, medical devices, in vitro diagnostic reagents, cosmetics, and household hazardous substance products.

Where can we get a copy of the guidelines for licensing of establishment and product registration? Guidelines may be downloaded from the BFAD Website thru the Laws and Regulations link: http://www.bfad.gov.ph/left_laws_regulations.htm. New guidelines may also be downloaded thru the New Issuances link: http://www.bfad.gov.ph/new_issuances.htm.