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
Part 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 (https://www.fda.gov.ph)
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Schedule A of the Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) is no longer applicable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:
List of Accredited Laboratories 2023 | |||
I. Private Laboratories | |||
1. ADIP Testing and Research Laboratory Inc. (ADIP TRLab Inc.) | |||
Address | : | 136 B Scout Fuentebella Street, Barangay Sacred Heart, | |
Kamuning, Quezon City, 1103 | |||
Telephone No. | : | (3) 410-0930 or (7) 799-2257 | |
Fax No. | : | 3410-0930 | |
: | [email protected] | ||
Contact Person | : | Beverly C. Leaño | |
Deputy Technical Director | |||
Field of Testing | : | Chemical Testing | |
2. Ascxent Knowledge Resources Inc. | |||
Address | : | Philippine Cooperative Center, No. 90 Balete Drive Extension, Quezon City 1112, Metro Manila | |
Telephone No. | : | (02)8638 5392 / 8463 4569 | |
Fax No. | : | None | |
: | [email protected] [email protected] [email protected] |
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Contact Person | : | Nida U. Autor | |
Laboratory Manager | |||
Field of Testing | : | Microbiological Testing and Chemical Testing | |
3. CHEMPRO Analytical Services Laboratories, Inc. | |||
Address | : | 2F-3F P1 Building, 131-135 Shaw Boulevard Barangay Oranbo, Pasig City | |
Telephone No. | : | (632) 8634-8600; 8635-6773 | |
Fax No. | : | (632) 8634-8600 | |
: | [email protected] | ||
[email protected] | |||
Contact Person | : | Marietta N. Bernardino | |
Marketing Manager | |||
Ivorie Gayle I. Sta Ana | |||
Administrative Manager | |||
Ronet L. Rodriguez | |||
Laboratory Head | |||
Field of Testing | Chemical Testing and Microbiological Testing | ||
4. 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 protected] | ||
Contact Person | : | Ms. Lovebeth S. Mendoza- Laboratory Manager Yehlen Salilid- Quality Assurance Manager |
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Field of Testing | : | Chemical Testing and Microbiological Testing | |
5. 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 protected] | ||
Contact Person | : | Ms. Evangeline B. Valdez | |
Laboratory Business Manager | |||
Yehlen Salilid- Quality Manager | |||
Field of Testing | : | Chemical Testing and Microbiological Testing | |
6. Franklin Baker Company of the Philippines- Davao Plant | |||
Address | : | Coronon, Sta. Cruz, Davao del Sur | |
Telephone No. | : | +632 810-2222 Ext. 130 | |
Fax No. | : | +6382 224-2422 Ext. 180 | |
: | [email protected] | ||
Contact Person | : | Ms. Hazel Jane F. Joaquin | |
Quality Assurance Manager | |||
Field of Testing | : | Chemical Testing and 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 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 protected] | ||
Contact Person | : | Ms. Edna C. Mijares President and CEOMs. 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 protected] | ||
Contact Person | : | Glenn U. Pagulayan Laboratory manager |
|
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 protected] | ||
Contact Person | : | Ms. Jennifer R. Maralit General Manager |
|
Field of Testing | : | Microbiological Testing and Chemical Testing | |
11. OSTREA Mineral Laboratories, Inc | |||
Address | : | Bgy. Road, Bo. Mamplasan, Biñan, Laguna | |
Telephone No. | : | (632) 8899058 | |
Fax No. | : | NA | |
: | [email protected] / [email protected] | ||
Contact Person | : | Alvin P. Basco Head of Operations |
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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 protected] | ||
[email protected], | |||
Contact Person | : | Armando Jerome de Jesus, Jr., PhD | |
Quality Assurance Manager | |||
Field of Testing | : | Chemical Testing | |
13. Qualibet Testing Services Corporation | |||
Address | : | 121 Dangay St., Project 7, Quezon City | |
Telephone No. | : | 374-8003/ 372-7993| M: 0917-5593287 | |
Fax No. | : | NA | |
: | [email protected] [email protected] |
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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) |
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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 protected] | ||
Contact Person | : | Ms. Priscila P. Tongco Laboratory Manager |
|
Field of Testing | : | Microbiological Testing and Chemical Testing | |
15. SGS Philippines, Inc. - Multi-Laboratory | |||
Address | : | 2229 Alegria bldg., Chino Roces Avenue, Makati City | |
Telephone No. | : | (02) 8784-9400 | |
Fax No. | : | NA | |
: | [email protected] [email protected] [email protected] |
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Contact Person | : | Jonalyn T. Samonte Laboratory Operations Manager Richardson Billones Jr. Technical Operations Manager – Chemical Testing Rosario P. Castillo Technical Operations Manager – Microbiological Testing |
|
Field of Testing | : | Microbiological Testing and Chemical Testing | |
16. XPRT Analytical Services | |||
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 protected] | ||
Contact Person | : | Edna L. Liwanag Laboratory Head |
|
Field of Testing | : | Chemical Testing | |
II. Government Laboratories | |||
1. Department of Science and Technology – I Regional Standards and Testing Laboratory |
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Address | : | DMMMSU-MLU Campus, San Fernando City, 2500, La Union | |
Telephone No. | : | (072) 242-4878 | |
Fax No. | : | (072) 242-4878 | |
: | [email protected], | ||
[email protected] | |||
Contact Person | : | Ms. Lena C. Rosario | |
Laboratory Head | |||
Field of Testing | : | Chemical Testing and Microbiological Testing | |
2. Department of Science and Technology – III Regional Standards and Testing Laboratory |
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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 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 Laboratory |
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Address | : | S & T Complex, Jamboree Road, Timugan, Los Baños Laguna | |
Telephone No. | : | (049) 536-4390 | |
Fax No. | : | (049) 536-4390 | |
: | [email protected], [email protected] | ||
Contact Person | : | Emelita P. Bagsit Quality Manager |
|
Field of Testing | : | Chemical Testing and Microbiological Testing | |
4. Department of Science and Technology – V Regional Standards and Testing Laboratory |
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Address | : | Regional Center Site, Rawis, Legazpi City | |
Telephone No. | : | (052) 482-0376; 105 loc. 113 | |
Fax No. | : | (052) 820-5039 | |
: | [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 Laboratory |
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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 |
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Field of Testing | : | Chemical Testing Microbiological Testing |
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6. Department of Science and Technology – VII Regional Standards and Testing Laboratory |
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Address | : | S & T Complex, Sudlon, Lahug, Cebu City | |
Telephone No. | : | (032) 254-7051 | |
Fax No. | : | (032) 254-7049 | |
: | [email protected] | ||
Contact Person | : | Robert Edra Laboratory Head |
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Field of Testing | : | Chemical Testing and Microbiological Testing | |
7. Department of Science and Technology – VIII Regional Standards and Testing Laboratory |
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Address | : | Government Center, Candahug, Palo, Leyte | |
Telephone No. | : | (053) 323-6356 | |
Fax No. | : | (053) 323-7110 | |
: | [email protected] | ||
Contact Person | : | Marilyn O. Radam | |
Field of Testing | : | Chemical Testing | |
8. Department of Science and Technology – IX Regional Standards and Testing Laboratory |
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Address | : | Pettit Barracks, Zamboanga City | |
Telephone No. | : | ( 062) 991-1024 | |
Fax No. | : | (062) 992-1114 | |
: | [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 Laboratory |
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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 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 Laboratory |
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Address | : | DMC Compound, Dumanlas Road, Bajada, Davao City | |
Telephone No. | : | (082) 227-5672/ 221-5428 | |
Fax No. | : | (082) 221-5295 | |
: | [email protected] | ||
Contact Person | : | Ms. Sheryl N. Napoco Deputy Quality Assurance Manager |
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Field of Testing | : | Chemical Testing and Microbiological Testing | |
11. Department of Science and Technology – XII (Satellite Laboratory) Regional Standards and Testing Laboratory |
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Address | : | Barangay Hall Compound, Calumpang, General Santos City | |
Telephone No. | : | (083)554-7997 | |
Fax No. | : | NA | |
: | [email protected] | ||
Contact Person | : | Ms. Samerah B. Macabalang-Datudacula Technical & Laboratory Manager |
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Field of Testing | : | Microbiological Testing | |
12. Department of Science and Technology – XIII (CARAGA) Regional Standards and Testing Laboratory |
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Address | : | CSU Campus, Ampayon, Butuan City | |
Telephone No. | : | (085) 342-6225 | |
Fax No. | : | (085) 342-9053 | |
: | [email protected] [email protected] |
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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 |
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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 protected] | ||
Contact Person | : | Engr. Angel L. Maguen Quality Manager |
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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. | : | NA | |
: | [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 |
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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 protected], [email protected] | ||
Contact Person | : | Rosalinda C. Torres, PhD, RCh, Quality Manager |
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Field of Testing | : | Chemical Testing and Microbiological Testing | |
16. Philippine Coconut Authority (PCA) | |||
Address | : | PCA Compound, Eliptical Road, Diliman, Quezon City, 1101 | |
Telephone No. | : | (632)8928-4501 loc 532 | |
Fax No. | : | N/A | |
: | [email protected] [email protected] [email protected] (copy furnish) |
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Contact Person | : | BENJAMIN R. MADRIGAL, JR. Administrator Philippine Coconut AuthorityMA. CELIA M. RAQUEPO Division Chief III Laboratory Services Division |
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Field of Testing | : | Chemical Testing and Microbiological Testing | |
17. Philippine National Collection of Microorganisms (PNCM) | |||
Address | : | Room 204, | |
National Institute of Molecular Biology and Biotechnology, | |||
UPLB, College, Laguna | |||
Telephone No. | : | 0946-200-1853 | |
Fax No. | : | none | |
: | [email protected] | ||
Contact Person | : | Dr. Rosario G. Monsalud | |
Scientist I | |||
Fellow, PAM | |||
Laboratory Manager, | |||
Technical Manager, Head Curator | |||
and Head Microbiologist | |||
ARMI R. CREENCIA | |||
[email protected] | |||
University Researcher II / Specialist Microbiologist / Quality Manager | |||
Field of Testing | : | Microbiological Testing | |
Civic Drive Filinvest Corporate City
(02) 8857-1900
local 1000
(02) 8842-5635
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