25 August 2009
ADMINISTRATIVE ORDER
No. ___________________
Subject:
Revised Schedule of Fees for Services Rendered by the Food and Drug
Administration
I.
RATIONALE:
The FDA’s financial sustainability is anchored on increases
in income/revenue, continued cost-effectiveness, enhanced financial management,
and an appropriate cost-recovery framework. Full financial sustainability
requires full cost recovery. Through all this, FDA is expected to pursue its
strengthening objectives and improvements of its services.
The rationale of the proposed fees and charges is financial sustainability consistent with RA9711 (Food and Drugs Administration Act of 2009) and RA9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008). However, expenditure and revenue forecasts for period 2010 to 2014 reveal that the difference between obligations and operating expenditures to fee generated from regulatory services under the current fee structure will result in a shortfall position.
Considering projected spending, financial figures reveal
that FDA’s projected income will not be sufficient to cover its projected
operational requirements under the current fees and charges. Additionally, the
projected expenditures do not account for FDA’s Programs/Activities/Projects
(PAPs) consistent with its strengthening measures and requirements, a
substantial amount of which is envisaged for the increase in staffing
complement, the upgrade and procurement of laboratory equipment, and
enhancements in FDA’s physical and human infrastructure. Given the intention to improve FDA’s’s regulatory function, BFAD is expected to face a
potentially large funding gap.
To be financially
sustainable, FDA must increase its income by at least 40 percent. The required
increase in income will have to be price driven. This is because growth in the
number of registered products and licensed establishment of about seven (7) to
ten (10) percent will be insufficient to cover the income increase requirement.
Further, it is important to note that about
fifty (50) percent of FDA’s income comes from registration fees, which can vary
considerably depending on market conditions and regulatory changes. This is
ascribed to the strong market dependence of the number of products being
registered to overall economic activity and changes in market demand. This
suggests that any significant economic event that may impact on the number of
applications submitted to FDA for registration of products will have a strong
bearing on FDA’s income/revenue stream.
II.
DECLARATION OF POLICY
Whereas, pursuant to Sec.54, Chapter 12, Book IV of Executive
Order No. 292 (Administrative Code of 1987), heads of bureaus, offices or
agencies, may upon approval of the department head, charge and collect the cost
of services rendered by the bureau, office or agency concerned;
Whereas, Executive Order No. 197 series of 2000 has been issued to reiterate the importance of revising the rates of fees and charges and to direct all departments, bureaus, commissions, agencies, offices and instrumentalities of the National Government, including government-owned and controlled corporations, to increase their rates of fees and charges by not less than 20 percent;
Whereas, pursuant to Section 17 of Republic Act No. 9711, the authorization and other fees shall annually be determined and reviewed by FDA upon sole approval of the Secretary; that there shall be determined and constituted additional fees such as sale of publications and services, assessment fees, fines, penalties and other fees and charges outside the usual licensing and registration fees, to be known as “ other regulated fees” ; and that the Director-General of the FDA, upon approval of the Secretary, shall be authorized to promulgate rules and regulations governing the collection of the “other related regulatory fees”.
At present, the basis for FDA’s current fees and charges is Administrative Order No. 50 s. 2001. These fees and charges have been in place since 2001 and do not reflect FDA’s cost structure and drivers. Given that fees and charges have been in place for eight (8) years, updating BFAD’s cost recovery program will help ensure financial sustainability, reduce any impending funding shortfall, and facilitate implementation of its strengthening measures and activities. A recent review of BFAD’s expenditure and revenue streams indicate a looming net budgetary shortfall. This underscores the urgency to revisit and revise BFAD’s fees and charges towards cost recovery and financial sustainability, following RA 9711 and RA9502.
III.
OBJECTIVE
This Administrative Order prescribes the schedule of fees for the services rendered by the Bureau of Food and Drugs in order to share the cost incurred by the Government in the regulation of products and establishments within its jurisdiction.
IV.
SCOPE
AND COVERAGE
This schedule of fees shall apply to all food, drug and cosmetics establishments and products, all private citizens who wanted to avail of any of the services of the FDA (e.g. licensing and registration services as well as other related regulatory services) including government agencies and personnel.
V.
SCHEDULE
OF FEES
This schedule of fees is prescribed for the following services of the FDA:
A. ESTABLISHMENT LICENSING
|
ITEMS |
Old Fees (AO50) |
New Fees |
||
|
|
Initial (1 year validity) |
Renewal (2 year validity) |
Initial (1 year validity) |
Renewal (2 year validity) |
|
1 a) Drug Outlets: |
||||
|
1.1 Drugstores |
|
|
|
|
|
Below 500K |
|
|
3,500 |
7,000 |
|
500K to below 1M |
|
|
4,000 |
8,000 |
|
1M to below 5M |
|
|
8,000 |
16,000 |
|
5M and Above |
|
|
11,500 |
23,000 |
|
1.2
Hospital Pharmacies
(c/o DoH one-stop shop) |
|
|
|
|
|
1.3
Retail Outlet for Non-Prescription Drugs |
|
|
3,500 |
7,000 |
|
1.4
Botika ng Barangay |
|
|
500 |
1,000 |
|
b)
Device Outlets |
1,000 |
2,000 |
3,500 |
7,000 |
|
2 Drug Distributors: Importers, Exporters, Wholesalers |
5,000 |
10,000 |
17,500 |
35,000 |
|
3 Medical Device Distributors: Importers, Exporters, Wholesalers |
4,000 |
8,000 |
14,000 |
28,000 |
|
4 Food Distributors: Importers, Exporters,
Wholesalers |
4,000 |
8,000 |
14,000 |
28,000 |
|
5 Iodized Salt Importers |
1,000 |
2,000 |
3,500 |
7,000 |
|
6 Cosmetic Distributors: Importers,
Exporters, Wholesalers |
3,000 |
6,000 |
10,500 |
21,000 |
|
7 Household Hazardous Substance Distributors: Importers, Exporters, Wholesalers |
3,000 |
6,000 |
10,500 |
21,000 |
|
8 Drug Manufacturers: |
||||
|
8.1
20 Million and below |
10,000 |
20,000 |
37,000 |
74,000 |
|
8.2
over 20 Million but below 50 Million |
15,000 |
30,000 |
54,000 |
108,000 |
|
8.3
50 Million and above |
20,000 |
40,000 |
70,500 |
141,000 |
|
9 Drug Traders: |
||||
|
9.1
20 Million and below |
3,000 |
6,000 |
11,500 |
23,000 |
|
9.2
over 20 Million but below 50 Million |
5,000 |
10,000 |
19,000 |
38,000 |
|
9.3
50 Million and above |
7,000 |
14,000 |
26,000 |
52,000 |
|
10 Cosmetic Manufacturers: |
||||
|
10.1 20 Million and below |
5,000 |
10,000 |
19,000 |
38,000 |
|
10.2 over 20 Million but below 50 Million |
10,000 |
15,000 |
37,000 |
74,000 |
|
10.3 50 Million and above |
15,000 |
15,000 |
54,000 |
108,000 |
|
11 Cosmetic Traders: |
||||
|
11.1
20 Million and below |
3,000 |
6,000 |
11,500 |
23,000 |
|
11.2
over 20 Million but below 50 Million |
5,000 |
10,000 |
19,000 |
38,000 |
|
11.3
50 Million and above |
7,000 |
14,000 |
26,000 |
52,000 |
|
12 Medical Device Manufacturers: |
||||
|
12.1
20 Million and below |
5,000 |
10,000 |
19,000 |
38,000 |
|
12.2
over 20 Million but below 50 Million |
10,000 |
15,000 |
37,000 |
74,000 |
|
12.3
50 Million and above |
15,000 |
20,000 |
54,000 |
108,000 |
|
13 Medical Device Traders: |
||||
|
13.1
20 Million and below |
3,000 |
6,000 |
11,500 |
23,000 |
|
13.2
over 20 Million but below 50 Million |
5,000 |
10,000 |
19,000 |
38,000 |
|
13.3
50 Million and above |
7,000 |
14,000 |
26,000 |
52,000 |
|
14 Food Manufacturers: |
||||
|
14.1
Micro SMEs |
|
|
1,500 |
3,000 |
|
14.2
1 Million and below |
1,000 |
2,000 |
4,000 |
8,000 |
|
14.3
over 1 Million but below 5 Million |
2,000 |
4,000 |
8,000 |
16,000 |
|
14.4
5 Million but below 10 Million |
3,000 |
6,000 |
11,500 |
23,000 |
|
14.5
10 Million but below 20 Million |
5,000 |
10,000 |
19,000 |
38,000 |
|
14.6
20 Million but below 50 Million |
10,000 |
20,000 |
37,000 |
74,000 |
|
14.7
50 Million and above |
15,000 |
30,000 |
54,000 |
108,000 |
|
15 Household Hazardous Substance Manufacturers: |
||||
|
15.1
1 Million and below |
1,000 |
2,000 |
4,000 |
8,000 |
|
15.2
over 1 Million but below 5 Million |
2,000 |
4,000 |
8,000 |
16,000 |
|
15.3 5 Million but below 10
Million |
3,000 |
6,000 |
11,500 |
23,000 |
|
15.4
10 Million but below 20 Million |
5,000 |
10,000 |
19,000 |
38,000 |
|
15.5
20 Million but below 50 Million |
10,000 |
20,000 |
37,000 |
74,000 |
|
15.6
50 Million and above |
15,000 |
30,000 |
54,000 |
108,000 |
|
16 Others |
||||
|
16.1 Bioequivalence
Testing Center (3-year validity) |
|
|
10,000 |
97,000 |
|
16.2 |
|
|
5,000 |
48,500 |
|
Amendment
of LTO (with inspection, refer to associate per diem costs in Annex 2) |
|
|||
|
-
with site inspection (manufacturer) |
1,000 |
|||
|
-
with site inspection (trader/distributor) |
1,000 |
|||
|
-
with site inspection (retailer) |
1,000 |
|||
|
- without site inspection |
500 |
|||
|
|
|
|||
|
Accreditation
of Bioequivalence Testing Center (3 year validity) |
20,000
(per year) |
|||
|
16.6 Accreditation
of Testing Laboratories |
20,000
(per year) |
|||
Note:
1)
All figures in Php.
B. AUDITS AND
INSPECTIONS
|
ITEMS |
New Fees |
|
I
GMP Audit (minimum of 2 inspectors / audit) |
|
|
1. Local (Including Food Fortification Inspection) |
Php 10,000 + GOP Local Per Diem Rate + Transportation Cost |
|
2 Overseas |
|
|
2.1 ASEAN Countries |
US$3,500 + UNDP Per Diem Rate + Transportation Cost |
|
2.2 (other than ASEAN) |
US$7,000 + UNDP Per Diem Rate + Transportation Cost |
|
2.3 All countries outside of Asia Pacific |
US$10,500 + UNDP Per Diem Rate + Transportation Cost |
|
II HACCP Audit / per product (minimum of 2 inspectors / audit) |
|
|
3
Local |
Php 10,000 + GOP Local Per Diem Rate + Transportation Cost |
|
4 Overseas |
|
|
4.1 ASEAN Countries |
US$3,500 + UNDP Per Diem Rate + Transportation Cost |
|
4.2 (other than ASEAN) |
US$7,000 + UNDP Per
Diem Rate + Transportation Cost |
|
4.3 All countries outside of Asia Pacific |
US$10,500 + UNDP Per Diem Rate + Transportation Cost |
|
III GDP / GSP Audit (applicable to all auditable
establishments) (minimum of 2 inspectors / audit) |
|
|
5 Local |
Php7,000 + Per
Diem/Per Inspector + Transportation Cost |
|
GCP/GLP audit of clinical trial
sites/ Bioavailability/Bioequivalence Testing Centres
(minimum of 2
auditors) |
|
|
6 Local |
Php 15,000 + Per Diem/Per Inspector +
Transportation Cost |
|
7 Overseas |
|
|
7.1 ASEAN Countries |
US$3,500 + UNDP Per Diem Rate + Transportation Cost |
|
7.2 (other than ASEAN) |
US$7,000 + UNDP Per
Diem Rate + Transportation Cost |
|
7.3 All countries outside of Asia Pacific |
US$10,500 + UNDP Per Diem Rate + Transportation Cost |
|
IV GLP Audit of Testing Laboratories |
|
|
8 Local |
Php10,000 + Per Diem/Per Inspector + Transportation Cost |
|
9 Overseas |
|
|
9.1 ASEAN Countries |
US$3,500 + UNDP Per Diem Rate + Transportation Cost |
|
9.2 (other than ASEAN) |
US$7,000 + UNDP Per
Diem Rate + Transportation Cost |
|
9.3 All countries outside of Asia Pacific |
US$10,500 + UNDP Per Diem Rate + Transportation Cost |
|
10 Product Information
File/Product Safety Audit |
Php7,000 same as GDP/GSP |
|
Fees for Product Registration |
(Old Fees) Initial (for 1 year) |
(Old fees) Renewal (for 5 years) |
Initial (for 3
years) |
Renewal (for 1 year) |
|
1 Drugs: |
|
|
|
|
|
1.1 New Drug/Monitored Release (3
yrs) |
6,667 |
20,000 |
210,000 |
70,000 |
|
1.2 Unbranded - over-the-counter
(low-risk), at least 4 apps/day; Prescription (high-risk; two
applications per day |
2,000 |
7,500 |
85,500 |
28,500 |
|
1.3 Branded - over-the-counter
(low-risk), at least 4 apps/day; Prescription (high-risk; two
applications per day |
3,000 |
10,000 |
108,000 |
36,000 |
|
2 Medical Device |
1,500 |
5,000 |
64,500 |
21,500 |
|
3 Diagnostic Reagents |
1,500 |
5,000 |
43,500 |
14,500 |
|
4 Food: |
|
|
|
|
|
4.1 Category I (low risk) |
200 |
1,000 |
4,500 |
1,500 |
|
4.2 Category 2 (high risk) |
250 |
1,250 |
9,000 |
3,000 |
|
4.3 Food Supplement / Health
Supplements |
1,000 |
5,000 |
75,000 |
25,000 |
|
4.4 Bottled Water |
1,000 |
5,000 |
28,500 |
9,500 |
|
5 Cosmetics: |
|
|
|
|
|
5.1 Notification |
750 |
3,750 |
21,000 |
1,250 |
|
+ 200.00 per variant or
100.00/variant if more than 6 variants |
||||
|
6 Household Hazardous Substance (including
Urban Pesticide |
500 |
2,500 |
9,000 |
3,000 |
|
7 Traditional Medicines (pegged at OTC low risk) |
3,000 |
10,000 |
75,000 |
25,000 |
|
8 Other Fees and Charges (per product): |
|
|
|
|
|
Registration (non-registrable
product) |
|
|
|
|
|
8.1
Re-Application: |
|
|
|
|
|
-
Drug, Device, Reagent |
1,000 |
|
9,500 |
|
|
- Food |
200 |
|
1,500 |
|
|
- Cosmetics |
250 |
|
2,000 |
|
|
- HHS |
250 |
|
2,000 |
|
|
8.2 Amendment of CPR (with technical
evaluation) |
|
|
|
|
|
- Food |
200 |
|
1,500 |
|
|
- Drugs, Devices, Re-agent, per
product/ per
change |
500 |
|
4,500 |
|
|
- Cosmetics/HHS per product, per change |
300 |
|
2,500 |
|
|
8.3
Extension of Shelf-life |
1,000 |
|
9,500 |
|
|
8.4
Drug |
|
|
|
|
|
Clinical review |
|
|
|
|
|
-
New Chemical/New Biological Entity/New Drug |
5,000 |
|
48,500 |
|
|
-
New Dosage Form/Strength/Line Extension |
2,500 |
|
24,000 |
|
|
- New Formulation/Reformulation (SUPAC
Guidelines |
2,500 |
|
24,000 |
|
|
-
Protocol for Monitored Release/ Post
marketing Surveillance Study |
2,500 |
|
24,000 |
|
|
-
Protocol for Clinical Trial/Study (Phases I to III) per
phase |
2,500 |
|
24,000 |
|
|
- Protocol Amendment per phase |
1,000 |
|
9,500 |
|
|
-
Extension of monitored release per year |
6,000 |
|
58,000 |
|
|
- Reclassification (Rx to OTC, OTC to DRHR etc.) |
3,000 |
|
29,000 |
|
|
-
Rationale for fixed-dose combination |
3,000 |
|
29,000 |
|
|
-
New Chemical/New Biological Entity/New Drug |
|
|
|
|
|
8.5
Cosmetics |
|
|
|
|
|
` - Approval for product/label claim |
500 |
|
4,500 |
|
|
Variation / Amendment
Fees |
|
|
9
Drug |
|
|
9.1 Major Variations |
|
|
- Major
A |
108,000 (following fees on drug registration application
–initial for 3 years) |
|
- Major
B |
35,000 (per product / per change) |
|
9.2 Minor
Variations |
4,000 (per product / per change) |
|
10 Medical
Device/Diagnostic Reagent/ Drug Screening Test
its/Food/Cosmetic HHS/Pesticide |
4,000 (per product / per change) |
|
11 Registration of Raw
Materials – API: |
|
|
-
API
require registration 1 CPR whether for production or distribution |
Php 2,000 initial mandatory for two
years; renewal is PhP 1,000 per year |
|
-
Listing/
notification of excipients and food additives (documentary
requirements: COA, MSDS, tech. specs, pro forma invoice, COS) |
free for initial year; renewal is Php 500 per year per excipients |
|
-
Clearance
to Import Antibiotics- (penicillin, amoxicillin, cloxacillin
(Raw material (EO 776)) |
4,000 per product |
|
12 Approval
for change in packaging materials/revision of packaging design (e.g. for
mergers/labeling design/ layout |
4,500 |
Note: All figures in Php.
|
ITEM |
AO 50 |
NEW FEES |
|
|
I. General Tests for All Products: |
|||
|
|
1. Physico-chemical
Tests and Assay |
||
|
|
1.1 Assay (Single Component) |
1,500 |
3,500 |
|
|
1.2
Assay (Double Component) |
|
6,000 |
|
|
1.3 Assay (Multi Component) |
2,000 |
9,000 |
|
|
1.4 Identification Test (Single Component) |
500 |
2,000 |
|
|
1.5
Identification Test (Double Component) |
|
3,000 |
|
|
1.6
Identification Test (Multi Component) |
|
5,000 |
|
|
1.7 Acid Insoluble Ash |
500 |
2,000 |
|
|
1.8
Alcohol determination (e.g.methanol, IPA) |
|
3,500 |
|
|
1.9
Fill Volume |
|
750 |
|
|
1.10 Hardness Test |
350 |
1,000 |
|
|
1.11 Loss on Drying |
300 |
2,000 |
|
|
1.12 Moisture content |
300 |
2,000 |
|
|
1.13 pH |
300 |
750 |
|
|
1.14 Refractive Index |
300 |
750 |
|
|
1.15 Residue on Ignition |
|
2,000 |
|
|
1.16 Saponification
Number |
500 |
1,250 |
|
|
1.17 Specific Gravity |
|
750 |
|
|
1.18 Turbidity |
|
750 |
|
|
1.19 Viscosity |
300 |
1,500 |
|
|
1.20 Visual/Organoleptic
Examination |
300 |
1,000 |
|
|
1.21 Organic Volatile Impurities |
|
5,000 |
|
|
1.22 Pesticide Residue |
2,000 |
20,000 |
|
|
1.23 Total Heavy Metals (4 elements) |
500 |
7,500 |
|
|
1.24 Other Heavy Metals (per metal) |
|
2,000 |
|
|
1.25 Arsenic |
300 |
2,000 |
|
|
1.26 Cadmium |
300 |
2,000 |
|
|
1.27 Chromium |
300 |
2,000 |
|
|
1.28 Lead |
500 |
2,000 |
|
|
1.29 Mercury |
300 |
2,000 |
|
|
1.30 Tin |
300 |
2,000 |
|
2. Microbiological Test |
|||
|
|
2.1 Commercial Sterility (thermally processed
foods in hermetically sealed containers) |
1,000 |
3,000 |
|
|
2.2
Preservative Efficacy Tests |
|
25,000 |
|
|
2.3 Sterility Tests (Injectables,
Medical Devices and Large Volume Parenterals) |
2,500 |
12,000 |
|
Microbial Limit Tests |
|||
|
|
2.4 Aerobic Plate Count |
500 |
1,500 |
|
|
2.5 Aerobic Thermophillic
Count |
500 |
1,500 |
|
|
2.6
Bacterial Spore Count |
|
1,500 |
|
|
2.7 Coliform Plate
Count |
500 |
1,500 |
|
|
2.8 Halophillic Yeast
Count |
500 |
1,500 |
|
|
2.9 Yeast and Mold Count |
500 |
1,500 |
|
|
2.10 Coliforms/ E.
coli (MPN) |
500 |
2,000 |
|
|
2.11 Psychrotrophic
Bacteria |
|
1,500 |
|
|
2.12 Lactic Acid Bacteria |
|
1,500 |
|
|
2.13 Bacillus cereus |
|
3,000 |
|
|
2.14 Staphylococcus aureus |
600 |
3,000 |
|
|
2.15 Candida albicans |
|
2,500 |
|
|
2.16 Clostridium perfringens |
|
3,000 |
|
|
2.17 Enterobacter sakazakii |
|
3,000 |
|
|
2.18 Enterobacteriaceae |
|
3,000 |
|
|
2.19 Escherichia coli |
|
3,000 |
|
|
2.20 Fecal Streptococci |
600 |
3,000 |
|
|
2.21 Listeria monocytogenes |
|
5,200 |
|
|
2.22 Pseudomonas aeruginosa |
600 |
3,000 |
|
|
2.23 Salmonella |
|
3,000 |
|
|
2.24 Vibrio parahaemolyticus |
|
3,000 |
|
3 Biological Test and Assay |
|||
|
|
3.1 Antibiotics-Microbial Assay |
2,500 |
6,250 |
|
|
3.2 Skin Irritation Test |
5,500 |
13,750 |
|
|
3.3
Depressor Substance Test |
|
5,500 |
|
|
3.4 Eye Irritation Test |
5,700 |
14,250 |
|
|
3.5 Paralytic Shellfish Poisoning Test (Red
Tide) |
1,000 |
2,500 |
|
|
3.6 Safety Test |
1,500 |
3,750 |
|
|
3.7 Acute Toxicity Test (Rat) |
22,000 |
55,000 |
|
|
3.8 Acute Toxicity Test (Mouse) |
10,000 |
25,000 |
|
|
3.9 Pyrogen Test |
5,200 |
13,000 |
|
|
3.10 Bacterial Endotoxin
Test (LAL) |
4,000 |
10,000 |
|
II.
Specific Tests for: |
|||
|
4 Processed Food Products |
|||
|
|
4.1
Total Dissolved Solids |
|
750 |
|
|
4.2
Water Conductivity |
|
750 |
|
|
4.3 Protein |
1,000 |
2,500 |
|
|
4.4 Fat/Oil |
500 |
2,500 |
|
|
4.5
Food Allergens |
|
5,000 |
|
|
4.6 Crude Fibers |
500 |
1,500 |
|
|
4.7 Dietary Fibers |
2,000 |
6,000 |
|
|
4.8 Total Solids |
300 |
1,000 |
|
|
4.9 Water Insoluble Solids |
300 |
1,000 |
|
|
4.10 Total Soluble Solids (Brix) |
300 |
750 |
|
|
4.11 Ash |
300 |
1,500 |
|
|
4.12 Filth |
500 |
1,250 |
|
|
4.13 Trans-Fatty Acids |
|
10,000 |
|
|
4.14 Peroxide Value |
500 |
1,250 |
|
|
4.15 Free Fatty Acids |
||