Republic of the Philippines Department of Health

Food and Drug Administration

Quality Medicines for Quality Care:

The Role of Regulatory Standards

MARK ANTHONY M. LEVISTE, MD, MBA Medical Officer III, Head Executive Assistant

Office of the Director-General Food and Drug Administration Philippines

2015 Philippine Pharmacists Association National Convention

I. Legal Bases for Regulation

II. The Food and Drug Administration

III.Mission, Vision, and Quality Policy

IV.Organizational Structure

V. Regulatory Framework Elements – How FDA Ensures the Quality of Medicines

Presentation Outline

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Republic of the Philippines Department of Health

Food and Drug Administration

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I. LEGAL BASES FOR REGULATION

• Republic Act No. 3720 (as amended) – Foods, Drugs and Devices, and Cosmetics Act

• Republic Act No. 9711 – Food and Drug Administration (FDA) Act of 2009

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Legal Bases

• Republic Act No. 9502 – Universally Accessible Cheaper Quality Medicines Act of 2008

• Republic Act No. 7394 – Consumer Act of the Philippines

• Republic Act No. 5921 – Pharmacy Law 5

Legal Bases

• Republic Act No. 6675 – The Generics Act of 1988

• Republic Act No. 10354 – The Responsible Parenthood and Reproductive Health Act of 2013

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Legal Bases

Republic of the Philippines Department of Health

Food and Drug Administration

II. The Food and Drug Administration

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FDA

• Office under the Department of Health

• Created in 1963 by virtue of Republic Act 3720 as amended by Exective Order No. 175, and subsequently Republic Act No. 9711

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General Reforms

IMPROVE EVALUATION

PROCESS

ENHANCE THE

INSPECTORATE

CLARIFY POLICIES AND

PRIORITIES

INCREASE LABORATORY

CAPACITY

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CLARIFY POLICIES AND

PRIORITIES

INCREASE LABORATORY

CAPACITY

General Reforms IMPROVE

EVALUATION PROCESS

ENHANCE THE

INSPECTORATE

Activity-based divisions to product oriented centers

Paperless application system Electronic payment system Publish online application

guidelines Rationalize application forms

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CLARIFY POLICIES AND

PRIORITIES

INCREASE LABORATORY

CAPACITY

General Reforms IMPROVE

EVALUATION PROCESS

ENHANCE THE

INSPECTORATE

Equip inspectors with tablets Set inspection protocols Equip REUs with firearms Police and military training

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CLARIFY POLICIES AND

PRIORITIES

INCREASE LABORATORY

CAPACITY

General Reforms IMPROVE

EVALUATION PROCESS

ENHANCE THE

INSPECTORATE

Procuring more laboratory equipment Continuous training and skills acquisition Improving laboratory security

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CLARIFY POLICIES AND

PRIORITIES

INCREASE LABORATORY

CAPACITY

General Reforms IMPROVE

EVALUATION PROCESS

ENHANCE THE

INSPECTORATE Review Remove Redundant Regulations ISO accreditation and certification IT administrative solutions Rationalize Clinical Trial Process Regulatory Alignment with other govt agencies

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• To ensure the safety, efficacy, and quality of health products

– Food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, and household/urban hazardous substances and/or a combination of and/or a derivative thereof

Mandate 14

Republic of the Philippines Department of Health

Food and Drug Administration

III. FDA Mission, Vision, and Quality Policy

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To ensure the safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with international best practice

MISSION 16

VISION

To be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos

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QUALITY POLICY

Our highest commitment is to ensure the safety, efficacy and quality of health products.

Toward this end, we commit to establish science-based standards as basis for regulatory policies, to continually improve and maintain our competencies in relation to our regulatory function, and to deliver quality public service with integrity.

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Republic of the Philippines Department of Health

Food and Drug Administration

IV. Organizational Structure

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FOOD AND DRUG ADMINISTRATIONOrganizational Structure

*Based on RA 9711

Director-General*

Deputy Director-General*for Administration and Finance

Deputy Director-General*for Field Regulatory Operations

Policy and Planning Service

Legal ServiceAdministrative & Finance

ServiceSouth Luzon FO(NCR, IV-A, IV-B, V)

Mindano West FO(IX, XII, ARMM)

North Luzon FO(CAR, I, II, III)

Visayas FO(VI, VII, VIII)

Policy Formulation & Program

Implementation

Monitoring and Evaluation Division

Investigation Division

Litigation & Enforcement

Division

Human Resource Development

Division

Inf ormation & Communications

Technology Mgt. Div .

Budget and Mgt. Division

Accounting Divison

General Services Division

Center for Device Regulation & Radiation Health & Research

Center for Food Regulation and Research

Center for Cosmetics Regulation and Research

Center for Drug Regulation and Research

Product Licensing and Registration

Division

Product Research & Stds. Dev't. Div.

Radiation Regulation Division

Physics Laboratory

Product Licensing and Registration

Division

Product Research & Stds. Dev't. Div.

Product Licensing and Registration

Division

Product Research & Stds. Dev't. Div.

Product Licensing and Registration

Division

Product Research & Stds. Dev't. Div.

Common Services Laboratory

Policy Dissemination and Training Division

Mindano East FO(X, XI, CARAGA)

Administrative and Finance Division

Establishment Licensing, Inspection

& Enf orcement Div ision

Administrative and Finance Division

Establishment Licensing, Inspection

& Enf orcement Div ision

Administrative and Finance Division

Administrative and Finance Division

Administrative and Finance Division

Establishment Licensing, Inspection

& Enf orcement Div ision

Establishment Licensing, Inspection

& Enf orcement Div ision

Davao Testing & Quality Assurance

Laboratory

Alabang Testing & Quality Assurance

Laboratory

Cebu Testing & Quality Assurance

Laboratory

Establishment Licensing, Inspection

& Enf orcement Div ision

Four centers according to product jurisdiction

Inspection

Laboratory analyses

Republic of the Philippines Department of Health

Food and Drug Administration

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V. Regulatory Framework Elements

1. Licensing and Inspection of establishments

2. Pre-marketing assessment

3. Post-marketing surveillance

4. Communication, Coordination, and Collaboration

Regulatory Framework Elements

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Establishments must comply with the requirements of different good practices:

• Good Manufacturing Practice

• Good Distribution Practice

• Good Storage Practice

• Good Laboratory Practice

• Good Clinical Practice

• Good Tissue Practice

Licensing and Inspection of

Establishments 23

Prior to the marketing of products:

1. The conduct of clinical trials must comply with ICH GCP

2. Proof of safety, efficacy, and quality must pass the requirements of FDA • For innovative drugs – full quality, safety, and efficacy review,

compliant with ASEAN reqts

• For generic drugs – full quality plus proof of interchangeability

Pre-marketing Assessment 24

Also included:

• Sample submission and evaluation

• Labeling review

• Review and imposition of post marketing commitments (where applicable)

Pre-marketing Assessment 25

Post-Marketing Surveillance

1. Pharmacovigilance

Safety monitoring of drugs on the market for unexpected health risks and informing the public of risks posed by specific drugs and other health products;

2. Monitoring, collecting, sampling and testing of drugs

3. Audits and inspection of manufacturers/ distributors/ retail outlets

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Post-Marketing Surveillance

4. Advertisements and claims monitoring

5. Consumer reporting of ADR/complaints processing

6. Product recall / Labeling revision/ restrictions on use

7. Other administrative sanctions

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Communication, Coordination, and

Collaboration

1. International Collaboration

• MFDS Korea – technical assistance on vaccines regulation, laboratory strengthening

• USP-PQM – monitoring of drugs in the market, particularly TB drugs and other anti-infectives

• EU-PHSRC – technical assistance on various areas: SBPs, radiopharmaceuticals, blood and blood products, OTCs, clinical trials, PV and SSFFC

• Other DRAs - trainings, GMP audits, dossier evaluations, coaching (Taiwan FDA, MFDS Korea, HSA Singapore)

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Communication, Coordination, and

Collaboration

2. Alignment with other government agencies

• Pharmaceutical Division – RUM, AMR, IEC development and dissemination

• HFSRB – Stem cell facilities

• Disease Prevention and Control Bureau (formerly NCDPC) – PV, safety information

• Epidemiology Bureau (formerly NEC/EPI) – vaccines monitoring, AEFI

• PRC-BOP – inspection of drug establishments and pharmacy practice

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Communication, Coordination, and

Collaboration

2. Alignment with other government agencies

• PDEA and DDB – policy-making and regulation of dangerous drugs

• BOC – regulation of imported drug products and raw materials

• PHREB and PHRR – monitoring and evaluation of clinical trials

• BOI – technical assistance on drug registration

• TESDA – trainings for personnel engaging in pharmacy services

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Communication, Coordination, and

Collaboration

2. Alignment with other government agencies • BAI and BFAR – regulation of veterinary drugs and products

• DTI-BPS – drug product and traditional medicines standards

• IPOPHL – patent protection, data exclusivity, trademarks

• NBI/PNP/DILG – SSFFC monitoring

• PhilHealth – Primary Care Benefit 2 (PCB2) package

• PITAHC –regulation of traditional medicine

• TESDA – trainings for personnel engaging in pharmacy services

• BOC – regulation of imported drug products and raw materials

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Communication, Coordination, and

Collaboration

3. Partnerships with professional associations and private institutions

• PPhA – PV, reporting of non-compliance to regulations, information dissemination

• PMA – referrals of malpractice of doctors

• ASC – technical assistance and capacity building on the monitoring of advertisements

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