role of nadfc (bpom) in health strengthening systems · dr. dra. l. rizka andalucia, m.pharm, apt....
TRANSCRIPT
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
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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
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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
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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
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THANK YOU
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