The Indonesian Food and Drug Authority ('' id, Badan Pengawas Obat dan Makanan, , Agency for Drug and Food Control'') or ''Badan POM''/''BPOM'' or Indonesian FDA, is a government agency of
Indonesia
Indonesia, officially the Republic of Indonesia, is a country in Southeast Asia and Oceania between the Indian and Pacific oceans. It consists of over 17,000 islands, including Sumatra, Java, Sulawesi, and parts of Borneo and New Guine ...
responsible for protecting public health through the control and supervision of
prescription and
over-the-counter
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...
pharmaceutical drug
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field an ...
s (medication),
vaccine
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. s,
biopharmaceutical
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
s,
dietary supplements,
food safety,
traditional medicine
Traditional medicine (also known as indigenous medicine or folk medicine) comprises medical aspects of traditional knowledge that developed over generations within the folk beliefs of various societies, including indigenous peoples, before the ...
and
cosmetics
Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protect ...
. The task and purposes of this agency is similar to the
USFDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
.
History
The predecessor of BPOM was formed during the
colonial period and was named (DVG). Operating under the auspices of the Dutch pharmaceutical company, DVG itself was in charge of producing chemical drugs as well as operating a pharmaceutical research center. In 1964, during the
Guided Democracy
Guided democracy, also called managed democracy, is a formally democratic government that functions as a ''de facto'' authoritarian government or in some cases, as an autocratic government. Such hybrid regimes are legitimized by elections th ...
era, DVG was nationalized and became the Pharmacy Inspectorate () of the Indonesian
Ministry of Health. Three years later, it was renamed the Inspectorate of Pharmaceutical Affairs (). In 1976, it was again renamed the Directorate General Drug and Food Control (, Ditjen POM).
In accordance with Presidential Decree No. 166/2000, the Directorate-General of Drug and Food Control was officially divested from the Ministry of Health to become an independent agency which reports directly to the president, though it continues to coordinate with the Ministry.
Since 2017, BPOM has been regulated by Presidential Decree No. 80/2017.
In 2020, the head of BPOM issued a decree regarding the standardization of English-language nomenclature used in reference to BPOM, which now includes an official translation of the agency name in English.
The agency was previously known in English as the National Agency for Drug and Food Control.
Task and function
Task
As stipulated in article 2 of Presidential Decree No. 80/2017, BPOM was tasked to execute government role in the field of drug and food control.
Function
According to article 3 of Presidential Decree No. 80/2017, BPOM has the following functions:
# Drafting and executing national policy in drug and food control;
# Drafting and establish norms, standard, procedure, and criterion in supervision on before and after obtaining
marketing authorisation
Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold.
This process is performed within a legal fr ...
;
# Executing supervision before and after obtaining marketing authorisation;
# Coordinating drug and food control within the central and regional governments;
# Providing technical assistance and supervision in drug and food control;
# Enforcing the law in regards to the field of drug and food control;
# Coordinating execution, supervision and administrative support for all entity within BPOM;
# Managing state assets within BPOM;
# Overseeing task and functions execution within BPOM.
Organization
Based on article 5 of Presidential Decree No. 80/2017, BPOM is organized into the following:
* Head of Indonesian Food and Drug Authority
* Secretariat General
* Deputy for Drug Control, Narcotics, Psychotropics, Precursors and Addictive Substances Supervision
** Directorate of Pharmaceutical, Narcotics, Precursors and Addictive Substances Standardization
** Directorate of Pharmaceutical Registration
** Directorate of Pharmaceutical, Narcotics, Psychotropics, and Precursors Production Supervision
** Directorate of Pharmaceutical, Narcotics, Psychotropics, and Precursors Distribution Supervision
** Directorate of Pharmaceutical, Narcotics, Psychotropics, Precursors, and Addictive Substances Safety, Quality, and Export-Import Supervision
* Deputy for Traditional Medicines, Health Supplements, and Cosmetics Supervision
** Directorate of Traditional Medicines, Health Supplements, and Cosmetics Standardization
** Directorate of Traditional Medicines, Health Supplements, and Cosmetics Registration
** Directorate of Traditional Medicines and Health Supplements Supervision
** Directorate of Cosmetics Supervision
** Directorate of Public and Business Empowerment in Traditional Medicines, Health Supplements, and Cosmetics
* Deputy for Processed Food Supervision
** Directorate of Processed Food Standardization
** Directorate of Processed Food Registration
** Directorate of Processed Food Supervision
** Directorate of Processed Food Distribution Supervision
** Directorate of Public and Business Empowerment in Processed Food
* Deputy for Law Enforcement
** Directorate of Prevention
** Directorate of Food and Drug Intelligence
** Directorate of Food and Drug Cyber
** Directorate of Food and Drug Investigation
* Inspectorate General
BPOM has four centers, those are:
* Center of Drug and Food Data and Information
* Center of Drug and Food Human Resource Development
* Center of National Drug and Food Testing Development
* Center of Food and Drug Research and Studies
BPOM has several Technical Implementation Units (TIUs) which spread across Indonesia. TIUs in NAFDC are Bureau () and Office ().
References
External links
National Agency for Drug and Food Control of Indonesia
Government agencies of Indonesia
Government agencies established in 1936
1936 establishments in the Dutch East Indies
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