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Public Consultation Expanded TWG Consultation Draft Schedule of - - PowerPoint PPT Presentation

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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

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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

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I. Legal Bases II. Background

  • III. Financial Review
  • IV. Salient Points

V. Proposed Fees and Charges

  • VI. Discussion

Presentation Outline

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Republic of the Philippines Department of Health Food and Drug Administration

  • I. Legal Bases

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Article XIII – Social Justice and Human Rights, Health, Section 12

The 1987 Constitution of the Philippines

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Chapter III – Creation of Food and Drug Administration, Section 4, f Chapter XIII – Financing, Section 31

Republic Act No. 3720

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Section 15

Executive Order No. 175

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Section 17 – Amending Section 31 of RA 3720

Republic Act No. 9711

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Section 17 – Amending Section 31 of RA 3720

Republic Act No. 9711

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Section 18

Republic Act No. 9711

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Chapter 4 – Strengthening of the Bureau of Food and Drugs, Section 31, (a)-(b)

Republic Act No. 9502

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Chapter 4 – Strengthening of the Bureau of Food and Drugs, Section 31, (a)-(b)

Republic Act No. 9502

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Republic of the Philippines Department of Health Food and Drug Administration

  • II. Background

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Administrative Order

  • No. 50 s. 2001

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Passing of RA 9502

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Passing of RA 9502

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Draft Revised Schedule of Fees 2009

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Draft Revised Schedule of Fees 2013

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Business Plan

  • February 2015 - approval of the organogram and

1st year staffing pattern

  • Revised schedule of fees is needed

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23 March 2015 FGD

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23 March 2015 FGD

  • Attendees:

– CHIPI – DSSAP – PAPPI – PAPVI – PCPI – PCRP – PPMA – PVDA

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March – June 2015

  • Creation of the FDA TWG for the review of fees

and charges

  • Financial advisor
  • Review of income, applications received

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  • Income retention
  • Withdrawal of government subsidy
  • Fees and charges as the only source of

funding support for operations and capital expenditures

Summary

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Republic of the Philippines Department of Health Food and Drug Administration

  • III. Financial Review

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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

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Findings

  • Main sources of revenue:

– Product Registration (49%) – License Fees (20%)

  • Main expense

– Personnel costs (45%)

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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

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Public Consultation

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Republic of the Philippines Department of Health Food and Drug Administration

  • IV. Salient Points

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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

Salient Points

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  • process of initial review on the

completeness of the documents submitted upon payment of assessment fee

  • Applicable for CPR applications
  • 1% of CPR

(1) Assessment and Fee

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  • 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

(2) Electronic authenticated copies

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Covered:

  • Receiving
  • Technical evaluation
  • Inspection
  • PMS
  • Printing, records management, archiving
  • Courier service

(3) Activities covered by fees and exclusive fees

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Exclusive:

  • LRF
  • Other fees for the use of payment collection

facilities

(3) Activities covered by fees and exclusive fees

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  • Applications made 6-3 months prior to

expiration of LTO/CPR

  • 10% discount. Provided compliant with

requirements

(4) Early Renewal

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  • For applications that have failed to meet

timelines for compliance

  • 1% of application fee
  • Resetting of timelines

(5) Re-application Fees

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  • CPR and LTO fees

– 50% in 2016 (initial and renewal) – 100% in 2016 (variations) – 100% in 2017 (initial and renewal)

  • Other fees

– 100% 2016

(6) Implementation Arrangements

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Republic of the Philippines Department of Health Food and Drug Administration

  • V. Proposed Fees

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License to Operate

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Category Fee (in PhP) Initial (2-year validity) Renewal (3-year validity) Variation MaV MiV-PA MiV-N Drug Manufacturer (Repacker, Packer) 110,000.00 (55,000) 157,000 (78,500) 9,500.00 1,500.00 1,500.00 Drug Trader/ Distributor (Exporter, Importer, Wholesaler) 30,000.00 (15,000) 36,500.00 (18,250) 6,500.00 1,500.00 1,500.00 Drugstore/Pharmacy/ Botica and similar

  • utlets

6,500.00 (3,250) 9,500.00 (4,750) 3,500.00 1,500.00 1,500.00 Retail Outlet for Non- Prescription Drugs (RONPD) 6,500.00 (3,250) 9,500.00 (4,750) 3,500.00 1,500.00 1,500.00 Sponsor/Contract Research Organization 30,000.00 (15,000) 36,500.00 (18,250) 6,500.00 1,500.00 1,500.00

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Product Registration

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Category

Fee (in PhP) Initial (5-year validity) Renewal (5-year validity) Variation MaV-A MaV-B MiV-PA MiV-N New Chemical Entity (NCE) 215,000.00 (107,500) 74,000.00 (37,000) 40,000.00 25,000.00 6,500.00 1,500.00 Generic Drugs 105,500.00 (52,700) 74,000.00 (37,000) 40,000.00 25,000.00 6,500.00 1,500.00 Biotechnological Products 235,000.00 (117,750) 94,000.00 (47,000) 40,000.00 25,000.00 6,500.00 1,500.00 Other Drug Product Classification 105,500.00 (52,700) 74,000.00 (37,000) 40,000.00 25,000.00 6,500.00 1,500.00

*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.

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Other Licensing/ Authorization Fees

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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 Permit for CT Use 1,000.00 CoPP 1,500.00 Product Classification 1,500.00

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General Certification Fees

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Category Fee (in PhP) Authenticated Copy first 5 copies Succeeding copies 500.00 50.00/copy Re-issuance 2,000.00 Certificate/ clearance/ verification/ special permit 500.00 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

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Republic of the Philippines Department of Health Food and Drug Administration

  • VI. Discussion

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