3rd twg-drug presentation - expanded twg on the new licensing

Republic of the Philippines Department of Health

Food and Drug Administration

Public Consultation Expanded TWG Consultation

Draft Guidelines on the Revised Licensing Requirements

Center for Drug Regulation and Research Food and Drug Administration

09 December 2015

I. Legal Bases

II. Background, Objective and Scope

III. Salient Points from AO 34

IV. Application Requirements

V. Inspection

VI. Variation

VII. Discussion

Presentation Outline

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“To ensure the safety, efficacy, and quality of drug products, all

establishments involved in the supply chain must continuously comply with

good practices”

Republic of the Philippines Department of Health

Food and Drug Administration

I. Legal Bases

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The 1987 Constitution

• Article II, Section 15

• Article XIII, Section 11

The 1987 Constitution

Republic Act No. 3720

Republic Act No. 9711

Republic Act No. 5921

Republic Act No. 7394

Republic Act No. 9502

Center for Drug Regulation and Research

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Republic Act No. 8792

Center for Drug Regulation and Research

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Republic of the Philippines Department of Health

Food and Drug Administration

II. Background, Objective, and Scope

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Administrative Order No. 2014-0034

Center for Drug Regulation and Research

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Drug Manufacturer

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Drug Distributor

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Drugstore/ Pharmacy/ Botica and other Similar Outlets

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RONPDs

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New Licensing Regulation for Drug

Establishments

• 13 October 2014

• Issued to align with recently promulgated laws

• Streamline regulations and requirements

• IRR issued 21 November 2014

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Rationale

• To improve FDA’s effectiveness and efficiency in carrying its mandate → harmonize and streamline processes and requirements in the approval of applications for LTO across all centers.

• more efficient and effective FDA will ensure availability of better quality health products in the market

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Harmonize and streamline requirements and process for approval

Objective 21

• Shall cover: – manufacturers, traders and distributors (importers,

exporters, and wholesalers) of drugs

– drugstores/pharmacies/boticas including hospital pharmacies and institutional pharmacies, and retail outlets for non-prescription drugs (RONPD)

• Shall not cover: – Organizations or persons engaged in donations,

medical missions and other humanitarian activities

– Sponsors and CROs (AO 2014-0034 and FC 2015-003)

Scope 22

Republic of the Philippines Department of Health

Food and Drug Administration

III. From AO 34

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• Section V General Guidelines (except for CRO/Sponsor related provisions)

• Section VI:

– Application Process (except inspection)

– Validity and Fees

– Cancellation

– Accessibility

• Penalty Clause

Retained Sections/Provisions

24

Republic of the Philippines Department of Health

Food and Drug Administration

IV. Application Requirements

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Initial Application

• Accomplished Application Form and Notarized Declaration and Undertaking

• Proof of Business Name Registration

• Site Master File (for manufacturers)

• Risk Management Plan

• Payment

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Renewal Application

• Accomplished Application Form with Notarized Declaration and Undertaking

• Payment

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Republic of the Philippines Department of Health

Food and Drug Administration

V. Inspection

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• Pre-opening inspection based on current best practices → mandatory for manufacturers

• All covered establishment may be inspected at any time by FDA as part of PMS activities in order to monitor continuous compliance with existing requirements and standards

Inspection 29

Republic of the Philippines Department of Health

Food and Drug Administration

VI. Variation

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• Major Variation

– changes in the operations of the establishment that may affect significantly and/or directly the aspects of safety and quality and when applicable, efficacy of products

– shall only be approved upon proper notification, submission of requirements to the FDA, and inspection

• Minor Variation

– changes in administrative matters and/or changes in the operations of the establishment with minimal impact on the safety and quality, or when applicable, the efficacy, of products.

Variations 31

• Major Variation

– Transfer of Location of Manufacturing Plant

– Expansion of Manufacturer

– Additional Production Line

– Change of Manufacturing Activity

– Transfer/Addition of Warehouse

Major Variations 32

• Minor Variation – Transfer of Location of Offices

– Change of Distributor Activity

– Expansion of Office Establishments

– Additional Drug Retailer Activity

– Change of Ownership

– Change of Business Name

– Zonal Change in Address

– Change of Qualified Personnel

– Deletion of Activity

Minor Variations 33

Republic of the Philippines Department of Health

Food and Drug Administration

VII. Discussion

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