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Republic of the Philippines Department of Health Food and Drug Administration Public Consultation Expanded TWG Consultation Draft Schedule of Fees and Charges of FDA Center for Drug Regulation and Research Food and Drug Administration 09 December 2015

Presentation Outline I. Legal Bases II. Background III. Financial Review IV. Salient Points V. Proposed Fees and Charges VI. Discussion 2

Republic of the Philippines Department of Health Food and Drug Administration I. Legal Bases 3

Article XIII – Social Justice and Human Rights, Health, Section 12 The 1987 Constitution of the Philippines 4

Chapter III – Creation of Food and Drug Administration, Section 4, f Chapter XIII – Financing, Section 31 Republic Act No. 3720 5

Section 15 Executive Order No. 175 6

Section 17 – Amending Section 31 of RA 3720 Republic Act No. 9711 7

Section 17 – Amending Section 31 of RA 3720 Republic Act No. 9711 8

Section 18 Republic Act No. 9711 9

Chapter 4 – Strengthening of the Bureau of Food and Drugs, Section 31, (a)-(b) Republic Act No. 9502 10

Chapter 4 – Strengthening of the Bureau of Food and Drugs, Section 31, (a)-(b) Republic Act No. 9502 11

Republic of the Philippines Department of Health Food and Drug Administration II. Background 12

Administrative Order No. 50 s. 2001 13

Passing of RA 9502 14

Passing of RA 9502 15

Draft Revised Schedule of Fees 2009 16

Draft Revised Schedule of Fees 2013 17

Business Plan • February 2015 - approval of the organogram and 1st year staffing pattern • Revised schedule of fees is needed 18

23 March 2015 FGD 19

23 March 2015 FGD • Attendees: – CHIPI – DSSAP – PAPPI – PAPVI – PCPI – PCRP – PPMA – PVDA 20

March – June 2015 • Creation of the FDA TWG for the review of fees and charges • Financial advisor • Review of income, applications received 21

Summary • Income retention • Withdrawal of government subsidy • Fees and charges as the only source of funding support for operations and capital expenditures 22

Republic of the Philippines Department of Health Food and Drug Administration III. Financial Review 23

Findings • Last adjustment of fees was in 2001, almost 15 years • Automation of services/electronic submission was implemented in 2013 to improve operation efficiency but no adjustments in rates • Replacement of equipment has been very selective • Last capital outlay approved for FDA was in 2006 24

Findings • Main sources of revenue: – Product Registration (49%) – License Fees (20%) • Main expense – Personnel costs (45%) 25

Findings • Net income will not be enough to support salary adjustments, inflationary adjustments, capital expenditures – FDA Rationalization Plan – 5-year prescriptive period for withdrawal of subsidy support • Thus the need to rationalize the FDA rates 26

Public Consultation 27

Republic of the Philippines Department of Health Food and Drug Administration IV. Salient Points 28

Salient Points 1) Assessment and assessment fee 2) Electronic authenticated copies 3) Activities covered by fees and exclusive fees 4) Early renewal 5) Re-application fee 6) Implementation arrangements 29

(1) Assessment and Fee • process of initial review on the completeness of the documents submitted upon payment of assessment fee • Applicable for CPR applications • 1% of CPR 30

(2) Electronic authenticated copies • a valid authorization, CPR or LTO, issued by the FDA for special purposes (e.g. as part of the requirements for bidding). • with bar code • 1 original copy • 19 e-copies 31

(3) Activities covered by fees and exclusive fees Covered: • Receiving • Technical evaluation • Inspection • PMS • Printing, records management, archiving • Courier service 32

(3) Activities covered by fees and exclusive fees Exclusive: • LRF • Other fees for the use of payment collection facilities 33

(4) Early Renewal • Applications made 6-3 months prior to expiration of LTO/CPR • 10% discount. Provided compliant with requirements 34

(5) Re-application Fees • For applications that have failed to meet timelines for compliance • 1% of application fee • Resetting of timelines 35

(6) Implementation Arrangements • CPR and LTO fees – 50% in 2016 (initial and renewal) – 100% in 2016 (variations) – 100% in 2017 (initial and renewal) • Other fees – 100% 2016 36

Republic of the Philippines Department of Health Food and Drug Administration V. Proposed Fees 37

License to Operate Fee (in PhP) Category Initial Renewal Variation (2-year (3-year MaV MiV-PA MiV-N validity) validity) Drug Manufacturer 110,000.00 157,000 9,500.00 1,500.00 1,500.00 (Repacker, Packer) (55,000) (78,500) Drug Trader/ 30,000.00 36,500.00 6,500.00 1,500.00 1,500.00 Distributor (Exporter, (15,000) (18,250) Importer, Wholesaler) Drugstore/Pharmacy/ 6,500.00 9,500.00 3,500.00 1,500.00 1,500.00 Botica and similar (3,250) (4,750) outlets Retail Outlet for Non- 6,500.00 9,500.00 3,500.00 1,500.00 1,500.00 Prescription Drugs (3,250) (4,750) (RONPD) Sponsor/Contract 30,000.00 36,500.00 6,500.00 1,500.00 1,500.00 Research Organization (15,000) (18,250) 38

Product Registration Fee (in PhP) Category Initial Renewal Variation (5-year (5-year MaV-A MaV-B MiV-PA MiV-N validity) validity) New Chemical Entity 215,000.00 74,000.00 40,000.00 25,000.00 6,500.00 1,500.00 (NCE) (107,500) (37,000) Generic Drugs 105,500.00 74,000.00 40,000.00 25,000.00 6,500.00 1,500.00 (52,700) (37,000) Biotechnological 235,000.00 94,000.00 40,000.00 25,000.00 6,500.00 1,500.00 Products (117,750) (47,000) Other Drug Product 105,500.00 74,000.00 40,000.00 25,000.00 6,500.00 1,500.00 Classification (52,700) (37,000) * Major Variation 1, 4, 5, 9, 10, 11, 12, 13 and Country Specific Major Variations as provided in FDA Circular No. 2014-008. For multiple variations on product registration with any major variation enumerated herein, only the major variation fee will be collected. 39

Other Licensing/ Authorization Fees Category Fee (in PhP) Permits and Clearances GLE Permit/year 1,500.00 Conversion to PCPR 1,500.00 CSP 6,000.00 Donation 1,500.00 Export Certificate 1,500.00 BOC Clearances Permit for Samples for Regn 1,000.00 Permit for CT Use CoPP 1,500.00 Product Classification 1,500.00 40

General Certification Fees Category Fee (in PhP) Authenticated Copy first 5 copies 500.00 Succeeding copies 50.00/copy Re-issuance 2,000.00 Certificate/ clearance/ verification/ 500.00 special permit CFS 1,000.00 Verification Certificate 1,000.00 Permit to Carry/Mail (Personal) 50.00/transaction Permit to Carry/Mail (R&D) 500.00 41

Republic of the Philippines Department of Health Food and Drug Administration VI. Discussion 42