Role of NADFC (BPOM)

in Health Strengthening Systems

Dr. Dra. L. Rizka Andalucia, M.Pharm, Apt.

Policy Discussion: A Comprehensive View toward ESRD Cost and Modality

InaHEA Annual Scientific Meeting 2018Thursday, 1 November 2018

Jakarta

Mandate and Regulatory Responsibility of The

NADFC (BADAN POM)

Protection of Public Health

Scientific Review and Good

Regulatory Practices

SupportingR&D and Product

Innovation

Safety Measure and Law

Enforcement

3 Pillars System within The

Mandate of Badan POM

1. to oversight medicines marketed in Indonesia in terms of quality, safety and efficacy assurance throughout the product life cycle in the pre-market and post-market control framework.

2. to support government on increasing provision of affordable medicines for public access.

Badan POM’s Responsibilities

2

Vision of BPOM:Safe Food and Medicine to Improve Public Health and National Competitiveness.

TASK & FUNCTION of BPOM IN MEDICINE CONTROL

Product

Manufacturing facility

PRODUCT Drug Registration

Marketing Authorization

DISTRIBUTION

CONSUMER

PRODUCT SAMPLING & LAB TESTING

Communication& Information

REGULATORY INSPECTION GMP& GDP

INDUSTRY

GMP Certificate

Drug labelling &

advertisement control

PRE-MARKETCONTROL

POST-MARKETCONTROL

R n D

3

Control of distribution channels

• sampling intensification for testing with proportional location selection

• Risk based sampling and testing

• GDP inspection

Control of production lines

• GMP inspection

• more upstream sampling (production facilities)

• Granting rewards and sanctions to the pharmaceutical industry

• Regulatory support and assistance to the pharmaceutical industry

Supporting drug availability

•Acceleration of drug registration (generic, new drug, Biological product)•Deregulation (Process

simplification)

• Implementation of electronic registration (New-Aero)

• Increase competency and quality of HR/evaluator

• Regulatory support and assistance • First track mechanism for

local drug development

• First product investment in Indonesia

•Medicine for national program use

STRATEGIC STEPS FOR INCREASING ACCESSIBILITY AND AVAILABILITY OF MEDICINE

4

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Dialysis consist of Haemodialysis and Peritoneal Dialysis

• Peritoneal Dialyses using clean solution contain glucose, electrolyte and lactate,

• Different from haemodialysis which blood is pumped out and return to the body by using an artificial kidney machine

• Authorized Medicine for Peritoneal Dialysis

– Extraneal

– Dianeal

– Dialisan

BPOM monitoring

compliance to QSE standard

Product Information

QUALITY EFFICACY &SAFETY

Based on Quality data:• Active substance• Finished productComply with cGMP

Should be:• complete• Objective• ClearTo ensure rational medicine use

Based on:• Nonclinical studies• Clinical studies

Evaluation Criteria

Criteria On Drug Evaluation(Risk Based Assessment)

Role of BPOM in CAPD Q,S,E Control

Ensuring QSE through evaluation on quality, non clinical and clinical studies

Ensuring the manufacturing process of CAPD comply with GMP compliance

BPOM is committed to support accessibility and availability of safe, efficacious and quality medicines.

Acceleration of drug registration and Regulatory support & assistance are strategic steps for increasing accessibility and

availability of safe, efficacious and quality medicines

CONCLUSION

8

THANK YOU

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