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In pursuant to FDA Circular No. 2014-003: Filing and Receiving of Registration, Licensing and Other Applications Using the Integrated Application Form, the following are the steps of the LTO and CPR Processing
CRO and Sponsor_Integrated Application Form.xlsxPart I
Part II
Part III
Part IV
Analytical Validation
Bioavailability & Bioequivalence Study
Provisional List
Process Validation
Stability
Variation
*Note: This is for establishments seeking to process their excise tax collection under the Bureau of Internal Revenue during the eighteen (18) month transitory period, pursuant to BIR Revenue Regulations No. 7-2021.
1. Secure a CCRR User Account by sending a request to [email protected] following the format below:
2. After securing the CCRR user account, log in at the FDA e-Portal (http://a0933.com)
3. Select “New Case” and accomplish the ASEAN Notification Form.
4. Download the Order of Payment and assign the task to FDA Cashier.
5. Pay the fee at any Landbank Branch or thru online Bancnet payment and wait for the Result of Application.
6. If approved, download and print the notice of acknowledgement.
7. For more information, you may download the following for your reference/guidance:
Do’s and Don’ts
1. Fields with red asterisk (*) are mandatory and shall not be left blank.
2. DO NOT COMMIT ANY SPELLING MISTAKE, FDA won’t be liable for this.
3. For the Restricted Ingredient, make sure to provide the function of that ingredient and its corresponding percentage.
IMPORTANT NOTE:
Schedule A of the Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) is no longer applicable
1. Letter of Intent
2. Photocopy of the following
3. Proof of payment (Php 510/product/country)
Note: If the cosmetic formulation contains placenta ingredient, submit the following:
Please see Issuances:
General Guidelines
License to Operate (LTO) and Certificate of Facility Registration (CFR) for an X-ray Facility
Scope: Free-standing Clinics and Dental Facilities, New Therapeutic X-ray Facilities utilizing Linear Accelerators, Transportable X-ray Facilities and Non-medical X-ray Facilities
Certificate of Compliance (COC) for the X-ray Facility
Scope: Medical X-ray Facilities under the DOH One-Stop Shop (OSS) Licensing System (Level 1, 2, and 3 General and Specialized Hospitals, Infirmaries, Primary Care Facilities, Ambulatory Surgical Clinics, and Medical Facility for Overseas Workers and Seafarers)
Certificate of Registration for Magnetic Resonance Imaging (MRI) Facilities
Pre-Operational Permit for Therapeutic X-ray Facility
Application Form for a Pre-Operational Permit of a Therapeutic X-Ray Facility
Certificate of Safety Evaluation (CSE) for Radiofrequency Radiation (RFR) Facilities
Scope: Radiofrequency emitting antennas and facilities (Indoor and Outdoor mobile phone base stations / cell sites, FM/AM and TV Stations)
Regulatory Standards and Requirements
General Guidelines
LIST OF ACCREDITED LABORATORIES 2020 | |
| I. PRIVATE LABORATORIES | |
| 1. Center of Excellence in Drug and Research, Evaluation and Studies, Inc. (CEDRES) | |
| Address: | 4/F BMD Building, RITM Compound, Filinvest
Corporate City, Alabang, Muntinlupa City |
| Telephone No.: | 8785-6379 |
| Fax No.: | N/A |
| Email: | [email protected] |
| Contact Person: | Salvador de Guzman Jr. Laboratory Manager |
| Field of Testing: | Chemical Testing |
| 2. F.A.S.T Laboratories Services and Technical Cooperative_Calamba | |
| Address: | Allied Concrete Building, Km. 54. Bgy. Makiling, Calamba City, Laguna |
| Telephone No.: | (02)584-4577; (049)-508-7138; 0917-562-6339+C29C20:C28 |
| Fax No.: | 635-6773 |
| Email: | [email protected]; This email address is being protected from spambots. You need JavaScript enabled to view it.;”>[email protected]; [email protected] |
| Contact Person: | Ms. Yehlen Ma. Salilid Quality Assurance Manager Dennis P. Sibongga Laboratory Business manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 3. F.A.S.T Laboratories Services and Technical Cooperative_CDO | |
| Address: | 2nd Floor, Asia United Bank Bldg., CM Recto Ave., corner Camp Alagar Road, Brgy. Lapasan, Cagayan de Oro City /2F 281 Tan-Leh Bldg., CM Recto Ave., Brgy Lapasan, CDO City |
| Telephone No.: | 088-880-8574; 088-852-4846; 09173753278 |
| Fax No.: | (02)913-8848 |
| Email: | [email protected] |
| Contact Person: | Ms. Lovebeth S. Mendoza- Laboratory Manager Yehlen Salilid- Quality Assurance Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 4. F.A.S.T Laboratories Services and Technical Cooperative_Cubao | |
| Address: | 62 20th Avenue Cubao Quezon City, 112 |
| Telephone No.: | (02)8913-0241 |
| Fax No.: | (02)8913-8848 |
| Email: | [email protected] |
| Contact Person: | Patricia B. Parales Laboratory Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 5. Franklin Baker Company of the Philippines- Davao Plant | |
| Address: | Coronon, Sta. Cruz, Davao del Sur |
| Telephone No.: | 82 286-2508 |
| Fax No.: | 82 224-2422 |
| Email: | [email protected] |
| Contact Person: | Ms. Hazel Jane F. Joaquin Quality Assurance Manager |
| Field of Testing: | Microbiological Testing |
| 6. GCH Center for Food Safety and Quality, Inc. | |
| Address: | 2F Tres Borces St., Brgy. Mabolo, Cebu City, 6000 Philippines |
| Telephone No.: | (32) 412-1229 (032) 232-1929 |
| Fax No.: | (32) 231-0103 |
| Email: | [email protected] |
| Contact Person: | Catherine Rose G. Aliganga – Laboratory Head Quennelyn M. Gaviola – Laboratory Supervisor |
| Field of Testing: | Microbiological Testing |
| 7. Intertek Testing Services Philippines, Inc. | |
| Address: | 2307 Chino Roces Avenue Extension Makati City |
| Telephone No.: | 8195841 loc 619 |
| Fax No.: | 8195848 |
| Email: | [email protected] |
| Contact Person: | Chester Lou A. Allones QMS/Compliance Officer |
| Field of Testing: | Chemical and Microbiological Testing |
| 8. JEFCOR Laboratories, Inc. | |
| Address: | Main St., Engineering Building, First Cavite Industrial Estate, Langkaan II, Dasmariñas, Cavite |
| Telephone No.: | (046)402-1318 |
| Fax No.: | (046)402-1318 |
| Email: | [email protected] |
| Contact Person: | Ms. Edna C. Mijares President and CEO Ms. Joselette G. Reyes-Blauta Technical and Marketing Manager |
| Field of Testing: | Chemical Testing |
| 9. Mach Union Water Laboratory, Inc. | |
| Address: | Mach Union Bldg., 335 Alabang-Zapote Road, Talon 3, Las Piñas City |
| Telephone No.: | (02) 553-8381,(02) 553-8382, (02) 553-8879 |
| Fax No.: | (02) 553-8878 |
| Email: | [email protected] |
| Contact Person: | Glenn U. Pagulayan |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 10. Optimal Laboratories, Inc. | |
| Address: | Purok I, Balintawak, Lipa 4217 Batangas |
| Telephone No.: | (043) 756-1292, (043) 702-4513, (02) 806-2863 |
| Fax No.: | (043)981-3992 |
| Email: | [email protected] |
| Contact Person: | Ms. Jennifer R. Maralit General Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 11. OSTREA Mineral Laboratories, Inc. | |
| Address: | Bgy. Road, Bo. Mamplasan, Biñan, Laguna |
| Telephone No.: | (632) 8899058 |
| Fax No.: | N/A |
| Email: | [email protected] / [email protected] |
| Contact Person: | Alvin P. Basco Head of Operations |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 12. Philippine Institute of Pure and Applied Chemistry (PIPAC) | |
| Address: | Ateneo de Manila University Katipunan Ave., Loyola Heights, Quezon City 1108 |
| Telephone No.: | (+632) 8426 6072; (+632) 84266001 loc. 4856, 4857) |
| Fax No.: | (+632) 8426 6073) |
| Email: | [email protected] [email protected], |
| Contact Person: | Armando Jerome de Jesus, Jr., PhD Quality Assurance Managerr |
| Field of Testing: | Chemical Testing |
| 13. Qualibet Testing Services Corporation | |
| Address: | 121Dangay St., Project 7, Quezon City |
| Telephone No.: | 374-8003/ 372-7993| M: 0917-5593287 |
| Fax No.: | N/A |
| Email: | [email protected] |
| Contact Person: | Joyce Tividad General Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 14. Sentro sa Pagsusuri, Pagsasanay at Pangangasiwang Pang-Agham at Teknolohiya Corp. (SENTROTEK Additional Scope of Accreditation for Water) | |
| Address: | No. 208 Pilar St., Brgy. Addition Hills, Mandaluyong City, 1550 |
| Telephone No.: | (02)8721-6500, (02) 8721-9699, (02) 8718-3514 |
| Fax No.: | (02) 8727-9016 |
| Email: | [email protected] |
| Contact Person: | Ms. Priscila P. Tongco Laboratory Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 15. SGS Philippines, Inc. – Multi-Laboratory | |
| Address: | 2229 Alegria bldg., Chino Roces Avenue, Makati City |
| Telephone No.: | (02) 8784-9400 |
| Fax No.: | N/A |
| Email: | [email protected] / [email protected] / [email protected] |
| Contact Person: | Neriza N. Ramos Laboratory Operations Manager Jonalyn T. Samonte Technical Operations Manager – Chemical Testing Rosario P. Castillo Technical Operations Manager – Microbiological Testing |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 16. XPRT Analytical Sevices | |
| Address: | 3759 Skrene Properties Bldg., Cuenca cor. Emilia Sts., Brgy. Palanan, Makati City |
| Telephone No.: | (+632) 8551 3422 loc. 132 |
| Fax No.: | (+632) 551 3330 |
| Email: | [email protected] |
| Contact Person: | Edna L. Liwanag Laboratory Head |
| Field of Testing: | Chemical Tesing |
| II. Government Laboratories | |
| 1. Department of Science and Technology – I Regional Standards and Testing Laboroatory | |
| Address: | DMMMSU-MLU Campus, San Fernando City, 2500, La Union |
| Telephone No.: | (072) 242-4878 |
| Fax No.: | (072) 242-4878 |
| Email: | [email protected] |
| Contact Person: | Anita A. Criste Laboratory Head |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 2. Department of Science and Technology – III Regional Standards and Testing Laboroatory | |
| Address: | Diosdado Macapagal Gov. Center, Maimpis, City of San Fernando Pampanga 2000 |
| Telephone No.: | (045) 455-0800, (045) 455-0554 |
| Fax No.: | (045) 455-0800 |
| Email: | [email protected] |
| Contact Person: | Diana Cecilia Estrella Technical Manager, Chemistry Laboratory |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 3. Department of Science and Technology – IVA (CALABARZON) Regional Standards and Testing Laboroatory | |
| Address: | S & T Complex, Jamboree Road, Timugan, Los Baños Laguna |
| Telephone No.: | (049) 536-4390 |
| Fax No.: | (049) 536-4390 |
| Email: | [email protected], [email protected] |
| Contact Person: | Emelita P. Bagsit Quality Manager |
| Field of Testing: | Chemical Testing Microbiological Testing |
| 4. Department of Science and Technology – V Regional Standards and Testing Laboroatory | |
| Address: | Regional Center Site, Rawis, Legazpi City |
| Telephone No.: | (052) 482-0376; 105 loc. 113 |
| Fax No.: | (052) 820-5039 |
| Email: | [email protected] , [email protected] |
| Contact Person: | Christopher G. Millena Laboratory Head |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 5. Department of Science and Technology – VI Regional Standards and Testing Laboroatory | |
| Address: | Magsaysay Village, La Paz, Iloilo City |
| Telephone No.: | (63 33) 320-0907; (63 33) 330-1565 Local: 108 |
| Fax No.: | (63 33) 320-0908 |
| Email: | [email protected]; [email protected] |
| Contact Person: | Ma. Lina B. Gelonga Laboratory Head |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 6. Department of Science and Technology – VII Regional Standards and Testing Laboroatory | |
| Address: | S & T Complex, Sudlon, Lahug, Cebu City |
| Telephone No.: | (032) 254-7051 |
| Fax No.: | (032) 254-7049 |
| Email: | [email protected] |
| Contact Person: | Robert Edra Laboratory Head |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 7. Department of Science and Technology – VIII Regional Standards and Testing Laboroatory | |
| Address: | Government Center, Candahug, Palo, Leyte |
| Telephone No.: | (053) 323-6356 |
| Fax No.: | (053) 323-7110 |
| Email: | [email protected] |
| Contact Person: | Marilyn O. Radam |
| Field of Testing: | Chemical Testing |
| 8. Department of Science and Technology – IX Regional Standards and Testing Laboroatory | |
| Address: | Pettit Barracks, Zamboanga City |
| Telephone No.: | (062) 991-1024 |
| Fax No.: | (062) 992-1114 |
| Email: | [email protected] |
| Contact Person: | Rosemarie Salazar Laboratory Head |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 9. Department of Science and Technology – X Regional Standards and Testing Laboroatory | |
| Address: | Jesus V. Seriña St., Carmen, Cagayan de Oro City |
| Telephone No.: | (088) 858-3931 to 33 loc 26, (088) 850-2653 |
| Fax No.: | (088) 858-3931, (088) 850-2653 |
| Email: | [email protected] |
| Contact Person: | Engr. Romela N. Ratilla, DPA Quality Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 10. Department of Science and Technology – XI Regional Standards and Testing Laboroatory | |
| Address: | DMC Compound, Dumanlas Road, Bajada, Davao City |
| Telephone No.: | (082) 227-5672/ 221-5428 |
| Fax No.: | (082) 221-5295 |
| Email: | [email protected] |
| Contact Person: | Ms. Sheryl N. Napoco Deputy Quality Assurance Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 11. Department of Science and Technology – XII (Satellite Laboratory) Regional Standards and Testing Laboroatory | |
| Address: | Barangay Hall Compound, Calumpang, General Santos City |
| Telephone No.: | (083)554-7997 ; 0997-632-5459 |
| Fax No.: | N/A |
| Email: | [email protected] |
| Contact Person: | Ms. Samerah B. Macabalang-Datudacula Technical & Laboratory Manager |
| Field of Testing: | Microbiological Testing |
| 12. Department of Science and Technology – XIII (CARAGA) Regional Standards and Testing Laboroatory | |
| Address: | CSU Campus, Ampayon, Butuan City |
| Telephone No.: | (085) 342-6225 |
| Fax No.: | (085) 342-9053 |
| Email: | [email protected] |
| Contact Person: | Jennifer Dejarme Laboratory Head |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 13. Department of Science and Technology – Cordillera Administrative Region (CAR) Regional Standards and Testing Laboratory | |
| Address: | BSU Compd., Km. 6, La Trinidad Benguet 2601 |
| Telephone No.: | (074) 422-0979, (074) 422-2214 |
| Fax No.: | (074) 422-0979, (074) 422-2214 |
| Email: | [email protected] |
| Contact Person: | Engr. Angel L. Maguen Quality Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 14. Food and Nutrition Research Institute (FNRI) -Service Laboratory | |
| Address: | FNRI Building, DOST Compound, Gen. Santos Ave., Bicutan, Taguig, City |
| Telephone No.: | (+632) 8837-8113 loc. 310, (+632) 8512-3077 |
| Fax No.: | N/A |
| Email: | [email protected] |
| Contact Person: | Ms. Rosemarie J. Dumag – Quality Manager Ms. Joan M. Castro – Chemical Laboratory Technical Manager Christine Eden C. Sevilla – Microbiological Laboratory Technical Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
| 15. Industrial Technology Development Institute (ITDI), Department of Science and Technology Standard Testing Division | |
| Address: | Department of Science and Technology Compound, Gen. Santos Avenue, Bicutan, Taguig City |
| Telephone No.: | (632)8837-2071 to 82 loc2198 |
| Fax No.: | (632)837-3167 |
| Email: | [email protected], [email protected] |
| Contact Person: | Rosalinda C. Torres, PhD, RCh Quality Manager |
| Field of Testing: | Chemical Testing and Microbiological Testing |
Civic Drive Filinvest Corporate City
(02) 8857-1900
local 1000
(02) 8842-5635
09617709691
09616845994
09610574926
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