Republic of the Philippines Department of Health
Food and Drug Administration
Focus Group Discussion
CDRR Fee Restructuring
Center for Drug Regulation and Research Food and Drug Administration
23 March 2015
I. Legal Bases
II. Background
III. Considerations for the Proposed Fees
IV. Inclusions
V. Sample Computation
VI. Proposed Fees and Charges
VII. Comparisons
Presentation Outline
2
Republic of the Philippines Department of Health
Food and Drug Administration
I. Legal Bases
3
Chapter III – Creation of Food and Drug Administration, Section 4, f
Chapter XIII – Financing, Section 31
Republic Act No. 3720 4
Section 15
Executive Order No. 175 5
Chapter 4 – Strengthening of the Bureau of Food and Drugs, Section 31, (a)-(b)
Republic Act No. 9502 6
Chapter 4 – Strengthening of the Bureau of Food and Drugs, Section 31, (a)-(b)
Republic Act No. 9502 7
Section 17 – Amending Section 31 of RA 3720
Republic Act No. 9711 8
Republic of the Philippines Department of Health
Food and Drug Administration
II. Background
9
Administrative Order No. 50 s. 2001
10
Passing of RA 9502
11
Passing of RA 9502
12
Draft Revised Scheduled of Fees
2009
13
Draft Revised Scheduled of Fees
2013
14
Business Plan
• February 2015 - approval of the organogram and 1st year staffing pattern
• Revised schedule of fees is needed
15
Republic of the Philippines Department of Health
Food and Drug Administration
III. Considerations for the Proposed
Fees
16
General
• Business Plan
– Financial sustainability through retention of income
– Reduce impending funding shortfall
– Facilitate implementation of strengthening measures and activities
• Inflation from 2003-2014*
• Growth in the number of establishments and products registered**
17
Inflation
18
Year Inflation Rate* 2002 2.7 2003 2.3 2004 4.8 2005 6.5 2006 5.5 2007 2.9 2008 8.3 2009 4.2 2010 3.8 2011 4.6 2012 3.2 2013 3.0 2014 4.1
Obtained from BSP Economic and Financial Statistics
Product Registered
19
Year Rx HR/OTC Vet Bio MO Total
2003 1298 50 45 27 6 1426 2004 1184 41 36 27 4 1292 2005 2055 46 72 62 0 2235 2006 3079 111 124 40 4 3358 2007 4055 265 284 81 9 4694 2008 4025 313 194 108 16 4656 2009 4460 295 270 68 7 5100 2010 5541 324 193 151 9 6218 2011 5282 379 178 143 7 5989 2012 5541 209 214 86 10 6060 2013 6498 357 223 104 6 7188 2014 5073 184 158 143 2 5560
Licensing Fees
• Drug Establishments – no SME classification
• Cover inspection fees once a year for every valid year
• Validity changes:
– Initial: from 1 year to 2 years
– Renewal: from 2 years to 3 years
• From amendment to variations:
– Major, Minor-Prior Approval, Minor-Notification
20
Registration Fees
• New drug classification:
– Investigational Product*
– New Chemical Entities
– Generic Products
– Biotechnological Products
– Other class: OTC, Veterinary, TM, HR, Medical Gas
• One-step submission – quality and clinical/non-clinical review (streamlined process)
21
Registration Fees
• Cover PMS fees (sampling and lab testing*) throughout the validity
• From amendment to variations:
– Major, Minor-Prior Approval, Minor-Notification
• Removal of the distinction between branded and unbranded registration fees
22
Laboratory Testing
Dosage Form Tests Considered
Tablets Visual Examination, Assay, Dissolution, Disintegration, ID Test, Purity Test, Moisture
Content
Capsules Visual Examination, Assay, Dissolution, ID Test, Purity Test, Moisture Content, pH, Aerobic
Plate, Aerobic Halophilic, Aerobic Thermophilic, Coliform Plate
Emulsion Visual Examination, Assay, ID Test, Purity Test, pH, Aerobic Plate, Aerobic Halophilic, Aerobic
Thermophilic, Coliform Plate
23 Dosage forms and the corresponding tests were derived from the ASEAN Guideline on Stability
of Drug Product
Laboratory Testing
Dosage Form Tests Considered
Oral Solutions/ Suspensions
Visual Examination, Assay, ID Test, Purity Test, pH, Aerobic Plate, Aerobic Halophilic, Aerobic
Thermophilic, Coliform Plate
Oral Powders for Reconstitution
Visual Examination, Assay, ID Test, Purity Test, Moisture content, pH, Aerobic Plate, Aerobic Halophilic, Aerobic Thermophilic, Coliform
Plate
Metered Dose Inhalation/Nasal
Aerosols
Visual Examination, Assay, ID Test, Purity Test, Aerobic Plate, Aerobic Halophilic, Aerobic
Thermophilic, Coliform Plate
24 Dosage forms and the corresponding tests were derived from the ASEAN Guideline on Stability
of Drug Product
Laboratory Testing
Dosage Form Tests Considered
Nasal Sprays Visual Examination, Assay, ID Test, Purity Test, pH, Aerobic Plate, Aerobic Halophilic, Aerobic
Thermophilic, Coliform Plate
Tropical Preparation
Visual Examination, Assay, ID Test, Purity Test, Moisture content, pH, Aerobic Plate, Aerobic Halophilic, Aerobic Thermophilic, Coliform
Plate
Ophthalmic/Otic Solution
Visual Examination, Assay, ID Test, Purity Test, Sterility
25 Dosage forms and the corresponding tests were derived from the ASEAN Guideline on Stability
of Drug Product
Laboratory Testing
Dosage Form Tests Considered
Suppositories Visual Examination, Assay, Dissolution, ID Test, Purity Test, Aerobic Plate, Aerobic Halophilic,
Aerobic Thermophilic, Coliform Plate
Small Volume Parenterals
Visual Examination, Assay, ID Test, Purity Test, pH, Sterility, LAL
Large Volume Parenterals
Visual Examination, Assay, ID Test, Purity Test, pH, Sterility, LAL
Drug Admixture Visual Examination, Assay, ID Test, Purity Test, pH, Sterility, LAL
26 Dosage forms and the corresponding tests were derived from the ASEAN Guideline on Stability
of Drug Product
Laboratory Testing
Dosage Form Tests Considered
Freeze Dried Products
Visual Examination, Assay, ID Test, Purity Test, Moisture Content, pH
27 Dosage forms and the corresponding tests were derived from the ASEAN Guideline on Stability
of Drug Product
28
Dosage Form Estimated Cost
Tablets 9070.6059
Capsules 12349.8315
Emulsions 8380.2429
Oral Solutions/ Suspensions 8380.2429
Oral Powders for Reconstitution 8898.0153
Metered Dose Inhalations/ Nasal Aerosols 7862.4705
Nasal Sprays 8380.2429
Topical Prep 8898.0153
Ophthalmic, Otic 8725.4244
Suppositories 11314.2867
SVP 16146.8292
LVP 16146.8292
Drug Admixture 16146.8292
Transdermal Patches 12177.2408
Freeze Dried Products 5446.1989
Republic of the Philippines Department of Health
Food and Drug Administration
IV. Inclusions
29
• Inflation adjusted licensing fees from 2001
• Inspector’s fee + TEV
• Indirect Costs*
Licensing Fees 30
• Inflation adjusted registration fees from 2001
• Clinical/non-clinical review including post-marketing commitments
• Brand name evaluation and acceptance
• PMS sampling and laboratory analysis
• Indirect Costs*
• For IPs – inclusive of Protocol review, ERB/ERC review
Registration Fees 31
• communication requirements, advocacy and advertisement costs (5%)
• development costs (5%)
• depreciation costs (7%)
• PMS contigency costs (2%)
• Contribution to the legal fund (1%)
Indirect Costs 32
Republic of the Philippines Department of Health
Food and Drug Administration
V. Sample Computation
33
Inflation adjusted Licensing Fee per year for 2 years
+ Inspector’s Fee
+ TEV
+ Indirect Costs
Initial Distributor Licensing Fee
34
• Initial Distributor Licensing Fee for 1 year
5000→8629.5405
8629.5405 x 2 years
17259.009
Inflation adjusted Licensing Fee per year for 2 years
35
• Average Inspector Salary per day
1000
• Average length of inspection of a Drug Distributor
x 2 days
• Initial LTO Validity
x 2 years
4000
Inspector’s Fee
36
• Reasonable TEV per day
400
• Average length of pre-opening inspection of a Drug Distributor
x 2 days
• Initial LTO Validity
x 2 years
1600
TEV
37
Inflation adjusted Licensing Fee per year for 2 years
+ Inspector’s Fee
+ TEV
+ Indirect Costs
Initial Distributor Licensing Fee
38
17259.009
+ 4000
+ 1600
Initial Distributor Licensing Fee
39
22,859.009 + indirect costs of 20% 27,430.8108 = 28,000
Inflation adjusted MR Fee for 5 years
+ Inflation adjusted NCE review
+ Post Marketing Commitments Review (from PMS protocol review fee)
+ Brand Name Acceptance+ 2 proposed Brand Names
+ Inflation adjusted lab testing fee
+ Sampling Costs
+ Indirect Costs
NCE
40
• New Drug Initial Registration for 3 years (AO 50)
20000→34518.1622
• New Drug Initial Registration to full 5 years (FC 2013-004)
+ 20000→34518.1622
69036.324
Inflation adjusted MR Fee for 5 years
41
• NCE Review fee (AO 50)
5000→8629.5405
• For 2 consultants for 3 days
8629.5405 x 2 consultants x 3 days
51777.243
Inflation adjusted NCE review
42
• PMS Protocol Review (AO 50)
2500→4314.7703
4314.7703
Post Marketing Commitments Review (from PMS protocol review fee)
43
• Brand Name Acceptance Fee (AO 50)
2500→4314.7703
• + 2 proposed brand names*
500→ 862.9541
+ (862.9541 x 2 = 1725.9082)
6040.6785
Brand Name Acceptance+ 2 proposed Brand Names
44
• Inflation adjusted average lab testing fee
10554.887 x 4 years
42219.548
Inflation adjusted lab testing fee for five years
45
• Reasonable TEV per day*
400 x 4 sampling
1600
Sampling Costs
46
Inflation adjusted MR Fee for 5 years + Inflation adjusted NCE review for 2 consultants
for 3 days + Post Marketing Commitments Review (from
PMS protocol review fee) + Brand Name Acceptance+ 2 proposed Brand
Names + Inflation adjusted lab testing fee + Sampling Costs + Indirect Costs
NCE
47
69036.324
+ 51777.243
+ 4314.7703
+ 6040.6785
+ 42219.548
+ 1600
NCE
48
174,988.564 + indirect costs of 20% 209,986.277 = 210,000
Republic of the Philippines Department of Health
Food and Drug Administration
VI. Proposed Fees
49
License to Operate
50
Category
Fee (in PhP)
Initial
(2-year
validity)
Renewal
(3-year
validity)
Variation
MaV MiV-PA MiV-N
Drug Manufacturer
(Repacker, Packer,
Trader)
100,000 150,000 9,500 1,100 1,100
Drug Distributor
(Exporter, Importer,
Wholesaler)
28,000 42,000 4,400 1,100 1,100
Drugstore/Pharmacy/B
otica and similar outlets
6,400 9,500 2,800 1,100 1,100
Retail Outlet for Non-
Prescription Drugs
(RONPD)
6,400 9,500 2,800 1,100 1,100
Sponsor/Contract
Research Organization
28,000 42,000 4,400 1,100 1,100
Other Licensing/ Authorization Fees
51
Category Fee (in PhP)
Permits and Clearances* 1,100
Foreign GMP Application Fees
Initial Application 10,000
Renewal Application 2,000
Re-issuance 1,000
Foreign GMP Inspection P3000 + Existing Inspector’s Fees
*Pemits and Clearances shall include:
Generic Labeling Permit / year
Conversion to PCPR
Special Permit
Donation Certificate
Re-issuance
Export Certificate
Sales Promo Permit
BOC Clearances for
o Drugs for Personal Use
o Import Permit for Samples of
Products for Registration
o Import Permit for Clinical Trial Use
Product Registration
52
Category
Fee (in PhP)
Initial
(5-year
validity)
Renewal
(5-year
validity)
Variation
MaV MiV-PA MiV-N
New Chemical Entity
(NCE)
210,000 66,000 64,000 6,300 1,100
Generic Drugs 97,000 66,000 64,000 6,300 1,100
Biotechnological
Products
237,000 86,000 64,000 6,300 1,100
Other Drug Product
Classification
97,000 66,000 64,000 6,300 1,100