Outline of the Project

Project Name

Project for Enhancing Drug and Food Safety

Subject

Health

Country

Indonesia

Date R/D Signed

August 27th, 2015

Project Site

Jakarta

Term of Cooperation

2016/7/11-2022/3/31

Implementing Organization

National Agency of Drug and Food Control

Background

In Indonesia, as a result of economic growth, ensuring the safety of processed foods, which is estimated to triple the market size from 2009 to 2020. In addition, the system for detecting side effects and health hazards is not sufficient for the drugs on the market. For this reason, it is in a state where it cannot be detected when health damage occurs to the general public information who ingested pharmaceuticals and processed products. The damage information cannot be disclosed to prevent it from spreading. This project will strengthen the functions of the Food Safety Department, Pharmaceutical Department, and Food Inspection Department of the National Agency of Drug and Food Safety Republic Indonesia, and support the establishment of a system for monitoring pharmaceuticals and processed foods, as well as respond promptly when problems occur.

The Overall Goal

Post-market control system for drug and food safety of NADFC in Indonesia is strengthened.

Project Purpose

Post-market control system for drug and food safety of NADFC at the central level and in the targeted provinces is strengthened.

Output

1. Food safety surveillance and control system in Indonesia is strengthened.
2. Post-market drug safety control system in Indonesia is strengthened.
3. Capacity of NQCLDF and NADFC regional laboratories for food testing is strengthened.

Project Activities

0-1	Organize Joint Coordinating Committee (JCC) meetings annually
0-2	Conduct a baseline survey
0-3	Conduct an end-line survey
1-1	Pre-and post-market processed food control
1-1-a	Train selected core technical personnel in Japanese food control system incl. food business license system, monitoring plan for domestically-distributed and imported food, in comparison with pre-and post-market control system applied in Indonesia
1-1-b	Develop report on pre- and post-market control system for processed food
1-2	Food safety crisis/ risk management
1-2-a	Train selected core technical personnel in food safety crisis/ risk management incl. case studies based on expertise of Japan
1-2-b	Develop guidelines and training program on food safety crisis/ risk management, and conduct training for NADFC staff, regional NADFC staff, etc.
1-3	Develop guidelines on traceability system for SMEs, and conduct training on traceability and withdrawal system for unsafe processed food
1-4	Food contact materials control
1-4-a	Train selected core technical personnel in food contact materials control including recycled plastic for food packaging
1-4-b	Develop guidelines and training program, and conduct training on food contact materials control for NADFC staff, regional NADFC staff, etc.
1-5	Processed food monitoring/ inspection program
1-5-a	Select parameters/ commodity combination for monitoring/ inspection program based on the activities under the Output 3
1-5-b	Conduct the monitoring/ inspection program
2-1	Develop risk analysis algorithm (incl. signal detection and evaluation for risk management plan), evaluation and decision making procedures for responding to drug safety issues, based on advanced Pharmacovigilance framework in Japan and/or other countries.
2-2	Train PV staff of NADFC Deputy I on the risk analysis algorithm (incl. signal detection and Evaluation for Risk Management Plan), evaluation and decision making procedures of adverse effects in Japan
2-3	Expand the operation of PV framework for regional centers (piloting in targeted Provinces) incl. development/ revision of manuals and procedures for reporting
2-4	Develop PV training module and materials, and conduct training for relevant parties, such as : - NADFC Regional offices (PV training modules including PV inspection) - NADFC staff (PV Inspection)- Pharmaceutical companies (PV training modules).
2-5	Develop guidelines and conduct training on internet investigation of counterfeit drugs
3-1	Conduct training on food testing of contaminants and pathogenic microbes in Japan, e.g. mycotoxin, heavy metal, veterinary drug residues, Enterohemorrhagic E. coli, L. monocytogenes and salmonella
3-2	Develop Standard Operational Procedures (SOPs) on testing methods and laboratory work based on the training
3-3	Conduct echo training for other lab staff of NADFC at the central and regional levels by trainers trained in 3-1
3-4	Conduct training based on Good Laboratory Practice (GLP) in NQCLDF and NADFC Regional Laboratories in the targeted provinces to strengthen quality assurance of food testing

Inputs

Japanese side

• Dispatch of Experts
• Training in Japan or in another country
• Provision of equipment
• Operational costs

Indonesian side

• Counterpart Personnel
• Provision of office space
• Operational cost