Republic of the Philippines Department of Health Food … Group... · Section 17 – Amending...

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