Indonesian Food and Drug Authority

Last updated

Indonesian Food and Drug Authority
Badan Pengawas Obat dan Makanan
BPOM
Logo Badan POM.png
Logo of Badan POM
Agency overview
Formed1936;88 years ago (1936)
Preceding agency
  • Directorate General of Drug and Food Control of Ministry of Health
Jurisdiction Government of Indonesia
HeadquartersJl. Percetakan Negara No.23, Central Jakarta 10520, Indonesia
Agency executive
  • Penny Lukito, Head of BPOM
Website www.pom.go.id

The Indonesian Food and Drug Authority ( Indonesian : Badan Pengawas Obat dan Makanan, lit.  'Food and Drug Supervisory Agency'), Badan POM/BPOM, or Indonesian FDA is a government agency of Indonesia responsible for protecting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medication), vaccines, biopharmaceuticals, dietary supplements, food safety, traditional medicine and cosmetics. The task and purposes of this agency is similar to the USFDA.

Contents

History

The predecessor of BPOM was formed during the colonial period and was named de Dienst der Volksgezondheid (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 era, DVG was nationalized and became the Pharmacy Inspectorate (Inspektorat Farmasi) of the Indonesian Ministry of Health. Three years later, it was renamed the Inspectorate of Pharmaceutical Affairs (Inspektorat Urusan Farmasi). In 1976, it was again renamed the Directorate General Drug and Food Control (Direktorat Jenderal Pengawasan Obat dan Makanan, Ditjen POM). [1]

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. [2] [1] Since 2017, BPOM has been regulated by Presidential Decree No. 80/2017. [3]

In 2020, the head of BPOM issued a decree regarding the standardization of English-language nomenclature used in reference to BPOM, which includes an official translation of the agency name in English. [4] 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. [3]

Function

According to article 3 of Presidential Decree No. 80/2017, BPOM has the following functions: [3]

  1. Drafting and executing national policy in drug and food control;
  2. Drafting and establish norms, standard, procedure, and criterion in supervision on before and after obtaining marketing authorisation;
  3. Executing supervision before and after obtaining marketing authorisation;
  4. Coordinating drug and food control within the central and regional governments;
  5. Providing technical assistance and supervision in drug and food control;
  6. Enforcing the law in regards to the field of drug and food control;
  7. Coordinating execution, supervision and administrative support for all entity within BPOM;
  8. Managing state assets within BPOM;
  9. Overseeing task and functions execution within BPOM.

Organization

Based on article 5 of Presidential Decree No. 80/2017, [3] and as expanded by BPOM Decrees No. 21/2020 and 13/2022, BPOM is organized into the following:

BPOM has four centers, those are:

BPOM has several Technical Implementation Units (TIUs) which spread across Indonesia. TIUs in NAFDC are Bureau (Balai Besar) and Office (Balai).

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References

  1. 1 2 Chryshna, Mahatma (21 January 2021). "Badan Pengawas Obat dan Makanan (BPOM)". Kompas (in Indonesian). Retrieved 3 October 2021.
  2. ↑ Keputusan Presiden RI Nomor 166 Tahun 2000 tentang Kedudukan, Tugas, Fungsi, Kewenangan, Susunan Organisasi, Dan Tata Kerja Lembaga Pemerintah Non Departemen (Presidential Decision 166) (in Indonesian). President of Indonesia. 2000.
  3. 1 2 3 4 Peraturan Presiden RI Nomor 80 Tahun 2017 tentang Badan Pengawas Obat dan Makanan (Presidential Decree 80) (in Indonesian). President of Indonesia. 2017.
  4. ↑ Keputusan Kepala Badan POM Tahun 2020 Nomor HK.02.02.1.2.03.20.115. Tentang Standardisasi Nomenklatur BPOM dalam Bahasa Inggris (Head of BPOM decree HK.02.02.1.2.03.20.115.) (in Indonesian). 2020.
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