The Comparisons of BPOM 20/2023 and BPOM 18/2021 As a Guidelines for Preclinical Pharmacodynamic Testing of Traditional Medicines
Nov 27, 2023
Indonesian herbal medicine has gained international recognition for its effectiveness and natural authenticity. Further, Indonesia is not just renowned for its traditional herbal medicine but is also its adaptability to modern wellness practices. As technological advancements progress, it is necessary to scientifically prove the efficiency of herbal medicine before they can be distributed under the supervision of National Agency of Drug and Food Control (“BPOM”).
Herbal medicines must adhere to safety, efficacy, and quality standards in order to be consumed safely by consumers. Traditional herbal medicines' efficacy can be validated through pre-clinical pharmacodynamic assessments, which involve evaluating their impact on animal testing.
On August 9 2023, BPOM issued BPOM No. 20 of 2023 on Guidelines for Preclinical Pharmacodynamic Testing of Traditional Medicines (“BPOM 20/2023”) which replaced the BPOM No. 18 of 2021 (“BPOM 18/2021”). BPOM 18/2021 was replaced with BPOM 20/2023 due to the determination that the guidelines were no longer in compliance with legal requirements and the rapid advancements in the field of traditional medicine brought about by science and technology.
Please see the table below for a comparison of BPOM 20/2023 and BPOM 18/2021.
| No. | BPOM 18/2021 | BPOM 20/2023 |
|---|---|---|
|
1. |
BPOM 18/2021 has been ratified on 7 July 2021. |
BPOM 20/2023 has been ratified on 9 August 2023. |
|
2. |
BPOM 18/2021 has been enacted on 9 July 2021. |
BPOM 20/2023 has been enacted on 9 Agustus 2023. |
|
3. |
BPOM 18/2021 consists of 4 articles in total. |
BPOM 20/2023 consists of 6 articles in total, with 1 amendment, 1 revocation and an additional of 2 articles. Amendment Amendments to Article 4 BPOM 20/2023, concerning the request for approval to conduct preclinical pharmacodynamic tests on traditional herbal medicine that was submitted before the enactment of BPOM 20/2023, shall continue to be processed in accordance with BPOM 18/2021. Revocation Revocation on Article 1 paragraph 5 which defines Research Institutions. Additional Article The addition of Article 5 BPOM 20/2023, as of the effective date of BPOM 20/2023, BPOM 18/2021 is revoked and declared invalid. |
|
4. |
BPOM 18/2021 is a guideline for using animal test to ensure the efficiency of traditional herbal medicine for the therapy of:
|
BPOM 20/2023 is a guideline that adding the efficiency of traditional herbal medicine using animal test for the therapy of:
|
As a result, it is hoped that the new guidelines of BPOM 20/2023 will serve as a benchmark for conducting preclinical assessments on test animals to establish the scientific effectiveness of traditional herbal medicines in Indonesia. Naturally, such testing must be conducted by qualified professionals in strict adherence to the principles of Good Laboratory Practice (GLP) and the ethical tenets of laboratory animal research, known as the '3R' principles, which encompass replacement, reduction, and refinement (JP/SAS).
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