Republic of the Philippines Department of Health …...•Republic Act No. 5921 – Pharmacy Law 5...
Transcript of Republic of the Philippines Department of Health …...•Republic Act No. 5921 – Pharmacy Law 5...
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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