(NAR) VOL. 15 NOS. 1-2 / JANUARY - MARCH 2004
BFAD in discharging this responsibility evaluates the following:a. all drug screening test kits/reagents submitted for registration (initial/renewal)
b. drug screening test kits/reagents submitted to BFAD for investigation by concerned citizens; and
c. drug screening test kits/reagents collected from licensed distributors for monitoring purposes.
- Applicant - refers to an establishment or a natural or juridical person that seeks to register drug screening test kits/reagents.
- Conformance - refers to the fulfillment of the requirements of the standard.
- Cut-off value of the drug testing kit - the concentration used to establish and report a specimen as negative or positive.
- Distributor/Exporter - refers to any establishment that exports raw materials, active ingredients and/or finished drug screening test kits/reagents to another country.
- Distributor/Importer - refers to any establishment that imports raw materials, active ingredients and/or finished drug screening test kits/reagents for its own use or for wholesale distribution to other establishment or outlets.
- Distributor/Wholesaler - refers to any establishment that procures raw materials, active ingredients and/or finished drug screening test kits/reagents from local establishment for local distribution on wholesale basis.
- Drug Screening Test Kits/Reagents - refers to testing device/reagents which is used alone or in combination intended for use in the examination of specific type of specimen for the purpose of preliminary identification of drug metabolite.
- Drug Trader - refers to any establishment which is the registered owner of the drug screening test kits/reagents, procures the raw materials and packing components, and provides the production monographs, quality control standards and procedures, but sub-contract the manufacture of such product to a licensed manufacturer.
- Gas Chromatograph-Mass Spectrometry - refers to the combined technique extensively used for qualitative and quantitative analysis. GC separates a sample into its components and MS operating as the detector of GC clarifies the structure. It is the established confirmatory method when a preliminary positive test results for drugs/metabolites is obtained.
- Manufacturer - refers to any establishment engaged in operations involved in the production of devices, including propagation, processing, compounding, finishing, filling, packing, re-packing, altering, ornamenting and labeling with the end in view of storage, distribution or sale of the drug screening test kits/reagents provided that for the purpose of this regulation the compounding and filling of prescriptions in drug testing laboratories and hospital shall not be considered as production operations.
- Negative control specimen - refers to synthetic or human urine specimen found below the cut-off value or absence of substance for drugs/metabolites.
- Performance Evaluation - refers to the procedures to verify the data submitted by the applicant.
- Positive control specimen - refers to synthetic or human urine specimen found positive or spiked with known concentrations of specific drugs/metabolites.
- Registration - means the process of approval to manufacture, import, export, sell, distribute or transfer any drug screening test kits/reagents that is determined to be safe, effective and in conformance to quality and safety standards.
- Samples - refer to the drug screening test kits/reagents subject for performance evaluation.
- Sensitivity - the ability of a test to detect all positive specimen for drug/metabolite. The smallest concentration of drugs/metabolite that can be detected.
- Specificity - the ability to discriminate between various similar drugs and identify all negative specimen for drugs/metabolites correctly.
- Standard - reference material of known purity or a solution containing a metabolite of known concentration.
- Test Efficiency - the over-all liability of a test to correctly identify positives and negatives. The combination of the sensitivity and the specificity of an assay to give an idea of the total effectiveness of the test.
- Notarized Letter of Application from manufacturer/trader/distributor.
- Valid License to Operate (LTO) as drug manufacturer/trader/distributor issued by BFAD.
- Government Certificate of Clearance and Free Sale/Registration Approval of the Product from country of origin and duly authenticated by territorial Philippine Consulate.
- Good Manufacturing Practice (GMP) Certificate attesting to the status of the manufacturer, competency and reliability of the personnel and facilities and duly authenticated by territorial Philippine Consulate.
- Certificate of Agreement between the manufacturer and trader/distributor regarding the product involved. If importer, it must be authenticated by the Philippine Consulate.
- Specific Use and Directions for Use. (Product insert)
- Copy of latest Certificate of Product Registration. (renewal)
- List of all raw materials used as components of the reagents/test kits.
- Technical specifications/physical description of the drug screening test kits/reagents.
- Process-control procedure and expected performance specifications.
- Flowchart of the manufacturing procedure.
- Stability studies of the product to justify claimed shelf-life. Signed by the authorized company representative.
- Immediate label, box label, package insert, brochure.
- Representative samples (2) in the market or commercial presentation
- Evidence of registration fee/payment (charge slip/official receipt)
- Letter of endorsement from BFAD.
- Letter of compliance to NRL-EAMC (In case of Deficiency)
- List of raw materials used as components of the drug screening test kits/reagents.
- Test Procedures/in-process controls to conduct Drug screening test kits.
- Physical description and technical specifications of the drug screening products which includes:
5.1 Data on sensitivity and specificity tests to be conducted for:5.1.1 Negative Specimens
One hundred twenty (120) independent analyses using three different lots at different concentration from 0 to 50% below of cut-off. All test results must be negative for drug.
5.1.2 Positive Specimens
One hundred twenty (120) independent anlyses using three different lots at different concentration from cut-off to 150% cut-off. All test results must be positive for drug.
5.2 Other statistical indices that shall describe the performance characteristics of the test kits.- Performance comparison studies with GC/MS.
- Certificate of analysis of finished product.
- Not less than 150 samples for evaluation.
- Evidence of registration fee/payment (charge slip/official receipt)
- All data/information must be submitted in English. When data/material is not originally in English, an authenticated translation shall be submitted.
- All text, drawings, pictures and photographs must be legible and drawings/picture clearly labeled and in full size four, (4) copies.
- BFAD/NRL reserves the right to ask any other requirement not indicated in this order but deemed necessary to support the reliability and authenticity of the submitted documents.
- The initial registration shall be valid for five years minimum of 2 years.
- For renewal registration, application shall be made on a form promulgated by the Bureau of Food and Drugs.
- Renewal application shall be reviewed and evaluated on the basis of the product and the applicant meeting the current BFAD and NRL-EAMC standards of identity, purity, quality and efficacy.
- Filing for renewal of registration of drug screening test kits/reagents shall be accepted starting ninety (90) calendar days before the expiry date.
- All requirements shall be submitted as indicated in the checklist of requirements (BFAD and NRL) as enumerated in Section V A and B.
- Application for renewal registration filed after the validity date of the registration shall be imposed with corresponding surcharge.
- The renewal registration shall be valid for five years minimum of three years.
- Application that failed to meet standards of safety, efficacy and quality shall be disapproved.
- Submission of requirement by the applicant to BFAD including issuance of order of payment/charge slip for registration.
- Evaluation of documents at the Product Services Division (PSD) - BFAD.
- Endorsement letter from the BFAD Director with attached complete documents listed in the NRL checklist to be forwarded to NRL.
- Review of documents by NRL.
- Issuance of Notice of Submission by NRL to the applicant.
- Payment of technical evaluation fee to NRL-EAMC by the Applicant.
- NRL performs technical evaluation of product samples.
- Submission of technical evaluation report and recommendation to Product Services Division (PSD-BFAD) for final action on the application for registration.
- Certificate of Registration (CPR) shall be issued by BFAD upon recommendation of the NRL.
- BFAD shall submit list of registered screening drug test kits/reagents to Bureau of Health Facilities and Services (BHFS), NRL and Dangerous Drugs Board (DDB). The same shall be posted in the Department of Health website.
- Fees shall be payable to BFAD for registration and NRL-EAMC for performance evaluation.
- Fees and charges are subject to change as may be deemed necessary.
- Expenses and fees (including freight and handling of samples) for laboratory testing, if required, shall be borne by the applicant.
- The manufacture, sale, offering for sale or transfer of drug screening test kits that does not meet all requisite specifications and product standards on safety, quality and effectiveness.
- Misrepresentation or concealment of significant data or information about the product sought to be registered.
- Alteration, mutilation, destruction, obliteration or removal of any part of labeling.
- Drug screening test kits that has a biological, chemical or physical property that may cause a health risk.
- Submission of falsified documents.
- Failure to notify BFAD of changes or alteration to the test.
- Invalid test results identified by users or through some other program/activities.