"This guide also aims to support Indonesia's self-reliance in drug production, especially human cell-based medicines. This is in line with Presidential Instruction No. 6 of 2016 on accelerating development of the pharmaceutical industry and medical device industry," BPOM's acting deputy for drug, narcotic, psychotropic precursor and addictive substance control, Rita Endang, noted in a written statement released on Friday.
Several sides have begun to study and use human cell-based drugs for treatment therapy in line with the developments in health technology, Endang pointed out.
Endang cited the example of stem cell used for the treatment of bone fracture, clogged blood vessel, and stroke.
To control the quality, efficacy, and security of human cell-based drugs before its widespread use among members of the public, the BPOM organized a meeting to disseminate information on its Regulation Number 18 of 2020 on a guide to evaluating human cell-based drugs, she noted.
Endang explained that the BPOM regulation is a policy issued to support the development of downstream human cell-based drugs since the start.
The guide covers a manual for the development and production of drugs, including quality control and the clinical and non-clinical development of human cell-based drugs to be produced en masse until the BPOM issues a circulation permit for the medicines.
The BPOM expects the guide to evaluate human cell-based medicines to serve as a comprehensive manual for both business agents and BPOM evaluators.
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