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FOOD AND DRUG ADMINISTRATION 18 January 2019

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Page 1: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

FOOD AND DRUG ADMINISTRATION18 January 2019

Page 2: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

AGENDA

1

2

3

About FDA

Way Forward

Regulatory Framework

Page 3: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

The Food and Drug Administration

Legal Basis

1963

RA 3720Creation of FDA

1982

EO 851BFAD

2009

RA 9711FDA Strengthening

Page 4: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

Current Organogam

Atty. Emilio L. Polig, Jr.OIC, Field Regulatory Operations

Office

Atty. Katherine M. Austria-Lock

OIC, Center for Drug Regulation and

Research

Ma. Cecilia C. Matienzo

OIC, Policy Planning Service

Atty. Michelle S. Lapuz

OIC, Legal Service

Racquel P. Alvendia, CPA, MBA-HDirector III,

Administrative and Finance Service

Fda Action

Center

Regulatory

Enforcement

Unit

Page 5: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

The Four Centers of the FDA

Center for Cosmetics Regulation and Research

Center for Drug Regulation and Research

Center for Food Regulation and Research

Center for Device Regulation, Radiation Health and Research

Health Product Center Product Jurisdiction

Human

Drug

Products

Veterinary

Drug

Products

Medical

OxygenTraditional

Medicine

Vaccine

and

Biological

Products

Cosmetic

Products

Household/

Urban

Hazardous

Substances

Household

Pesticides

Toys and

Childcare

Articles

Processed Food

Products

Raw Materials

for Food

Food

Supplements

Medical

Devices

Radiation-

emitting

Devices

Health-

related

Devices

Radiation

Facilities

Page 6: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

REGULATORY FRAMEWORK

Post-marketing Surveillance

Pre-Market Approval

Licensing and Inspection

Page 7: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

FDA Core Funtions

Licensing of Establishments

• Manufacturers

• Traders

• Distributors/ Importers/ Exporters/ Wholesalers

• Retailers/ (Drugstores)/ Operators/ Applicators

Registration of Health Products

• Drug

• Food and Food Supplements

• Medical Devices

• Household/Urban Pesticides

• Cosmetics (Notification)

• Toys and Childcare Articles (Notification)

Post-Marketing Surveillance

• Inspection

• Health Product Vigilance

• Enforcement

• Advertisements and Promotions Regulation

Page 8: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

Barriers and Challenges

Manpower Complement vs mandated functions

Outdated System

Bureaucratic

Process

Fast technology

change

Never-ending

new products

Consumer/

Stakeholder

Demands

Page 9: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

WAY FORWARD

FDA Three Marching Orders

72-hour Turnaround Time

Zero Backlog Strengthened Enforcement

Page 10: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

FDA ACTION CENTER (FDAC)

Bringing the services nearer to our stakeholders

Page 11: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

Ease of Doing Business

Page 12: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

KKK PROGRAMKAAGAPAY SA KALUSUGAN AT KALIGTASAN

FDA – DOH Program

Main Objective: Improve turnaround time for laboratory testing of

government procured pharmaceutical products

Page 13: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

MSME: DTI-DOH-FDA Program FOCUS: Micro Enterprise of Food Products: Pilot Program

APPLICANT START

PAYMENT

INSPECTION

EVALUATION /

CHECKING

APPROVAL / DENIAL

ISSUANCE OF LTO/LOD

PRINTING &

RELEASING

90 CALENDAR DAYS PROCESSING TIME

PRE-ASSESSMENT

AND ISSUANCE OF

LETTER OF

ENDORSEMENT

APPLICATION

START

CONDUCT OF

INSPECTION

EVALUATION OF

APPLICATION

PRINTING &

RELEASING

15 CALENDAR DAYS PROCESSING TIME

OLD PROCESS

PROGRAMLicense to Operate

Page 14: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

DIGITAL TRANSFORMATION

Page 15: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

International Alignment

• Harmonization of Technical Requirement and Standards

• FDA Accession Plan

Pharmaceutical Inspectorate Cooperation Scheme PIC/S (>45

countries)

WHO Global Benchmarking Tool (pre-qualification for WHO listed

inspectorate)

ASEAN GMP Mutual Recognition Arrangement (MRA)

Page 16: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration
Page 17: FOOD AND DRUG ADMINISTRATION - PIDS Admin · FOOD AND DRUG ADMINISTRATION 18 January 2019. AGENDA 1 2 3 About FDA Way Forward Regulatory Framework. The Food and Drug Administration

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