Head of the National Agency of Drug and Food Control

Medical and Pharmaceutical Session EIBD Conference

Jakarta, 30 November 2010 1

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TOPICS

NATIONAL DRUG POLICY 2006

Objectives :

To ensure 1. Availability, accessibility and affordability of essential drugs 2. Safety, efficacy and quality of marketed drugs. 3. Rational drug use

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STRATEGIC ENVIRONMENT ON DRUG AND FOOD CONTROL

  Commitment on Trade Liberalisation :  Non-dicrimination,  Harmonisation

The main concern is to Protect Public Health

  Increasing “product competitiveness”

STRATEGIC ISSUE

Change of Strategic Environment

1. Regulation 2. Free Trade (Regional, International) 3. In-country Market Protection

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Strategic Issue ( 1)

FREE TRADE

 ASEAN Free Trade Area (AFTA)  ASEAN Charter Single Market  ASEAN - China Free Trade Agreement (ACFTA)

Harmonisation of Standard & Requirement For Drug and Food

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Strategic Issue ( 2)

In – Country Market Protection

 Law Enforcement combating illegal and counterfeit products

 Fulfillment of standards and requirements  Enhancement of competitiveness

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Drug and Food Control System including the ability of reliable laboratory

Strategic Issue (3)

STRATEGIC POLICY OF NADFC 2010-2014

1. Strengthening Regulatory System on Drug and Food Control

2. Strengthening reliable Drug and Food laboratory

3. Increasing Management capacity of NADFC 4. Strengthening cross-sector networking in

Drug and Food Control

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Strategic Steps (general)

  Revitalization and adjustment of Drug and Food Regulation

  Strengthening control system based on international standard, including harmonization and strategic control based on Quality Risk Management (QRM)

  Revitalization and Synchronizing roles, tasks, and responsibilities of NADFC and NADFC Regional Office

  Enhancement of partnership with Province and District/City government, stakeholders in the field of drug and food

  Strengthening NADFC Quality Management System (QMS)

  Enhancement of capability and professionalism of human resources

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Strategic Steps (on Pharmaceuticals/Drugs )

  Preparation of regulatory development roadmap in pharmaceutical sector in Indonesia in purpose to enhance global competitive strategy and to face the ASEAN and FTA harmonization with emerging countries (China, India)

  Intensify effort on in-country drug control in order to safeguard domestic market from illegal, counterfeit and substandard products.

  Increasing public service i.e .one roof services; development of electronic drug registration system, strengthening (atau establishment) drug certification GMP,GDP ,service on NSW.

  Preparation of IND Like System concept, including technology transfer and formula development (BA/BE)

  Strengthening regulatory to support drug exportation

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OPERATIONAL POLICY ON DRUG CONTROL

1.  Determine roadmap of regulatory development on pharmaceuticals/drugs

2.  Enhancement of public service on electronic based drug registration

3.  Strengthening regulatory and technical aspect on pharmaceutical industries in Indonesia

4.  Strengthening regulatory and technical aspect on drug distribution sector in Indonesia

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1999 -

2004

1999 – 2004:

Revitalization and Improvement Era

  Reinforcement of drug registration system in order to implement concept on ACTR,ACTD, ASEAN GL

  Mapping concept on pharmaceutical industry profile and its implementation

  Implementation of current GMP concept

  Preparation of GDP concept

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OPERATIONAL POLICY ON DRUG CONTROL (1)

2004 -

2006

2005 -

2007

2006 -

2008

2004 – 2009:

Transition and Adaptation Era

  Dissemination and voluntary implementation of ACTR and ACTD

  Strengthening technical supervision and mapping of Pharmaceutical Industries & GDP

  Corrective Action and Preventive Action (CAPA) for Pharmaceutical Industries

  Adjustment to current standard and requirement (Continuous Improvement) on GMP and GDP

OPERATIONAL POLICY ON DRUG CONTROL (1)

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2010 -

2012

2012 -

2014

2010 – 2014:

“the Turning Point” Era

  Compulsory Implementation and evaluation of ACTR and ACTD implementation

  Technical supervision including specific supervision for certain group of Pharmaceutical industries, implementation of GMP re-certification and GDP certification

  Re-certification & consistent implementation of GMP re-certification result for drug registration

OPERATIONAL POLICY ON DRUG CONTROL (1)

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Equivalent Era

Self Reliance

Era

2015 - 2020

Equivalent and Self Reliance Era

  Comprehensif concept of Pharmaceutical Industry equivalent to International requirements

  Self reliance of Pharmaceutical Industry in support to Economic and National Health Development

OPERATIONAL POLICY ON DRUG CONTROL (1)

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To enhance public service on electronic based drug registration :

Goal : To enhance professionalism and transparency of drug registration

service, including providing assurance of timeframe

Activities : •  Electronic queue system and document screening •  Revision of Head of NADFC decree, guidance and SOPs, e.g. Criteria

& Procedure of Drug Registration •  Establishment of online registration system gradually •  Harmonization of result on manufacturer control with drug

development for registration purpose •  To enhance professional communication amongst NADFC and

stakeholders related to drug registration

OPERATIONAL POLICY ON DRUG CONTROL (2)

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Strengthening Regulatory and Technical Aspect in Pharmaceutical Industry :

Goal : Strengthening cGMP implementation and pharmaceutical industry professionalism as well as`increasing competitiveness

Activities : •  Input for Revision of Minister of Health Decree No 245/1990 •  Improvement of cGMP Guideline •  Preparation of NADFC to be a member of PIC/s •  Strengthening capacity for preparation of ASEAN GMP MRA •  Implementation of GMP re-certification , Toll Manufacturing and

New Drug Registration based on status of GMP certificate. •  Preparation concept for control of Investigational New Drug (IND

Like System), including technology transfer and development of formula (BA/BE)

•  Improvement of professional communication between NADFC and stakeholder related to GMP implementation

OPERATIONAL POLICY ON DRUG CONTROL (3)

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Strengthening Regulatory and Technical Aspects in Distribution of Pharmaceutical in Indonesia:

Goal : Implementation of GDP and improvement of wholesalers professionalism to ensure consistency of drug quality

Activities : •  Input for Revision of Minister of Health Decree No. 1191/ 2002 on

Wholesalers •  Dissemination of GDP and mapping of wholesale profil for vaccine

distribution to GMP Implementation •  Strengthening preparation of GDP certification •  Intensify control for distribution chanel to avoid illicit and illegal

pathways •  Improvement of professional communication between NADFC and

stakeholder related to GDP implementation

OPERATIONAL POLICY ON DRUG CONTROL (4)

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Goal : Improvement of accuracy and professionalism of pre market evaluation in ensuring drug efficacy, safety and quality

Activities : •  Screening of drug registration document through integrated

electronic system. •  Intensify fullilment of drug registration requirements •  Verification of quality document in order to fulfill GMP

compliance to increase domestic product competitiveness •  Development of Risk Evaluation and Mitigation Strategy

(REMS) of new drugs.

Improvement of drug Evaluation Concept (Pre Market)

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  National and International Pharmaceutical Industry Association (GP Farmasi and IPMG) Industry involvement on discussion for revision of regulation, e.g. :  revision of The Decree of Ministry of Health No. 245/1990;  revision of The Decree of the Head of NADFC on Criteria

and Procedure of Drug Registration

  Working Group on Pharmaceutical and Cosmetics between EU and Indonesia

  Industry Involvement on discussion and drafting new technical guidance for harmonization in ASEAN, e,g :   ASEAN Stability GL;  ASEAN BA/BE GL

COLLABORATION WITH STAKEHOLDER IN PHARMACEUTICAL SECTOR

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  Synergy strategic efforts need to be

implemented in order to establish beneficial

Drug and Food sector in globalization era.

  The concept of “Growth with Equity” (in

purpose to be perceived in community)

becomes philosophy of policy on Drug and

Food Control, despite priority of efficacy,

safety and quality assurance of drug and food

CONCLUSION (1)

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  Drug Control needs a comprehensive Drug

Quality Assurance in the framework of Total

Drug Quality Management (TDQM) with the

implementation of systematic cGMP, GLP,

GSP, GDP, GPP and QMS

  Collaboration with stakeholder strengthens

NADFC regulatory framework to keep in line

with regional and international

harmonization.

CONCLUSION (2)

ThankYouTerimaKasih