Kamis, Agustus 24, 2023

Updated Guidelines on the Preclinical Pharmacodynamic Testing of Traditional Medicines Issued

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - "BPOM") has updated the Guidelines for the Preclinical Pharmacodynamic Testing of Traditional Medicines (collectively referred to as "Testing"), through the issuance of Regulation No. 20 of 2023, which has been in force since 9 August 2023.
These guidelines should now be used as a reference by the following parties: 1) Evaluators (during evaluations of traditional medicines); or 2) Registrars (during the implementation of Testing, research and development).
The guidelines are comprehensively set out under the Appendix to the Regulation, including chapters on general guidelines that address various arrangements concerning the following areas: 1) Ethical clearance; 2) Implementation approvals for preclinical testing; 3) Application of good laboratory practice during animal testing (cara berlabroaturium hewan uji yang baik); 4) Management of testing; and 5) Management of animal testing. Various arrangements for Testing based on the relevant therapy classes are also regulated under the Appendix to the Regulation.

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*Syarat dan ketentuan berlaku

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - "BPOM") has updated the Guidelines for the Preclinical Pharmacodynamic Testing of Traditional Medicines (collectively referred to as "Testing"), through the issuance of Regulation No. 20 of 2023, which has been in force since 9 August 2023.
These guidelines should now be used as a reference by the following parties: 1) Evaluators (during evaluations of traditional medicines); or 2) Registrars (during the implementation of Testing, research and development).
The guidelines are comprehensively set out under the Appendix to the Regulation, including chapters on general guidelines that address various arrangements concerning the following areas: 1) Ethical clearance; 2) Implementation approvals for preclinical testing; 3) Application of good laboratory practice during animal testing (cara berlabroaturium hewan uji yang baik); 4) Management of testing; and 5) Management of animal testing. Various arrangements for Testing based on the relevant therapy classes are also regulated under the Appendix to the Regulation.

......

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