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.Read More
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 berikutRead More
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.Read More