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The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products.  WHO consider the role of the Drug Regulatory Authority (DRA) in a country as an essential part of the health system that contributes to the health status of the community. Inefficient drug control systems will make access barriers to safe, qualified and efficacious medicines and vaccines.

 

Indonesia is one of the exporting country of vaccine in South East Asia region to the low income countries. Indonesia has produced 12 vaccines that have been exported to 130 countries. Since 1997, 12 vaccine products from Indonesia has gained WHO recognition of the WHO Pre-Qualification (PQ). With such confidence, only a few vaccine producers have the capacity to supply vaccines for the prevention of infectious diseases around the world to improve global health quality. Exports of vaccines are conducted through global health agencies such as the United Nations Children 's Fund (UNICEF), the Global Alliance of Vaccines and Immunization (GAVI) and the Pan American Health Organization (PAHO), thereby the global harmonization of the pharmaceutical industry in Indonesia will contribute to global access of qualified vaccine products from Indonesia. National Agency of Drug and Food Control (NADFC) ensures the quality, efficacy and safety of medicines, including vaccines in order to provide benefits in the framework of patient safety. NADFC control activity starts from the process of assessment of efficacy, safety and quality of the drugs, supervision of production process in accordance with Good Manufacturing Practice (GMP), supervision of distribution in accordance with Good Distribution Practice (GDP) including cold chain products, and also post market safety surveillance through pharmacovigilance activities.

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Pada tahun ini World Immunization Week campaign diperingati pada tanggal 24 sampai dengan 30 April 2018, kampanye ini bertujuan untuk menegaskan kembali bahwa vaksinasi dapat melindungi seluruh lapisan masyarakat. Tema yang diangkat dalam kampanye ini adalah “Protected Together, #VaccinesWork”. Imunisasi dapat melindungi semua kelompok umur – dari bayi hingga lanjut usia – melawan penyakit, kecacatan dan kematian akibat penyakit yang dapat dicegah melalui pemberian vaksin. Berita selengkapnya terkait World Immunization Week campaign dapat dilihat di tautan berikut

World Immunization Week

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Starting this year and for the next four years, NADFC will go into partnership with Japan International Cooperation Agency (JICA) to ensure the safety of pharmaceutical products and food products in Indonesia; one of them is concerning the activities of Pharmacovigilance. A series of activities to promote this project have been carried out. From 23 to 30 September, 2013 JICA once again gave supports to “Strengthening of Pharmacovigilance Activities” as the follow-up activities of the joint project. Several staff members of NADFC and Provincial office of NADFC were sent to Japan to learn and to observe directly the system of Japanese Pharmacovigilance and to get the positive points to be implemented in Indonesia. Those activities were participated by Director of Distribution Control of Therapeutic Product and Household Medical Supplies, the Chairman of Provincial Office of NADFC in Medan, the Chairman of Provincial Office of NADFC in Padang, the Chairman of Provincial Office of NADFC in Menado, Section Head of Surveillance of Therapeutic Product and Household Medical Supplies, and also staff members of Directorate of Distribution Control of Therapeutic Product and Household Medical Supplies and staff members of Directorate of Drug and Biological Product Evaluation.

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Pharmacovigilance program in Indonesia has been started and promoted by NADFC (National Agency for Drug and Food Control) as the national drug control authority. The main goal of pharmacovigilance program is not only to improve patient's safety of using drugs, but also to contribute towards the evaluation of benefit, danger, effectiveness and risks of using certain drugs, and also to encourage the safety, rationality, and effectiveness (including cost savings) of using drugs.

So far, the system that has been adopted in Indonesia concerning this activity is a spontaneous report delivered by health professionals using a yellow form which is a standard report of adverse drug reactions. It needs efforts to improve feedbacks because the reporting rate of spontaneous reporting system is still low compared to the number of population or the number of drugs distributed in Indonesia. To overcome these challenges, Indonesia has to strengthen they system and network of pharmacovigilance in all areas and healthcare facilities.

Based on what have been done, WHO once again offered its supports to NADFC to strengthen the program of pharmacovigilance in Indonesia by holding a workshop for health professionals with the theme of Strengthening Drug Safety Monitoring in Indonesia—National Pharmacovigilance Workshop from October 23 to October 25, 2017 in Bekasi. The workshop was attended by 135 participants consisting of hospitals and Community Health Centers in Sumatra, Java, and Bali, Health Department of DKI Jakarta (either Provincial Health Department or Public Health Service of DKI Jakarta), Health Department of Bekasi City, Health Department of Tanggerang City, and also Provincial Office of NADFC in Jakarta, Bandung, Semarang, Surabaya and Serang.

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