Rabu, Oktober 26, 2022

BPOM Set to Introduce Updated Guidelines for Preclinical Pharmacodynamic Trials of Traditional Medicines

In an attempt to ensure that the applicable guidelines for preclinical pharmacodynamic trials of traditional medicines ("Guidelines") are in line with current scientific and technological developments, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will adjust some of the provisions set out under the Guidelines, as previously addressed under Regulation of the BPOM No. 18 of 2021 ("Regulation 18/2021"). Ultimately, when the Draft Regulation comes into force, Regulation 18/2021 will be repealed and replaced.
The Guidelines can be utilized as a reference by the following parties: 1) BPOM evaluators when carrying out evaluations of the efficacy of traditional medicines based on scientific protocols and/or preclinical pharmacodynamic trials; and 2) Traditional pharmaceutical businesses who are submitting applications for the preparation of supporting data in order to support the efficacy of their medicines and to conduct research and development activities in relation to traditional medicines.
The above-mentioned applicants may use other methodologies based on valid scientific references and/or methods that have been approved by the BPOM when carrying out research and development activities in relation to traditional medicines.
The BPOM is currently soliciting input on this Draft Regulation up until a deadline of 28 October 2022. Said inputs may be submitted via the following email address: [email protected] cc: [email protected] by downloading the format available at https://bit.ly/FormMasukanFarmakodinamikLanjutan.

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*Syarat dan ketentuan berlaku

In an attempt to ensure that the applicable guidelines for preclinical pharmacodynamic trials of traditional medicines ("Guidelines") are in line with current scientific and technological developments, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will adjust some of the provisions set out under the Guidelines, as previously addressed under Regulation of the BPOM No. 18 of 2021 ("Regulation 18/2021"). Ultimately, when the Draft Regulation comes into force, Regulation 18/2021 will be repealed and replaced.
The Guidelines can be utilized as a reference by the following parties: 1) BPOM evaluators when carrying out evaluations of the efficacy of traditional medicines based on scientific protocols and/or preclinical pharmacodynamic trials; and 2) Traditional pharmaceutical businesses who are submitting applications for the preparation of supporting data in order to support the efficacy of their medicines and to conduct research and development activities in relation to traditional medicines.
The above-mentioned applicants may use other methodologies based on valid scientific references and/or methods that have been approved by the BPOM when carrying out research and development activities in relation to traditional medicines.
The BPOM is currently soliciting input on this Draft Regulation up until a deadline of 28 October 2022. Said inputs may be submitted via the following email address: [email protected] cc: [email protected] by downloading the format available at https://bit.ly/FormMasukanFarmakodinamikLanjutan.

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