ANALYZING THE IMPACT OF THE BUSINESS LICENSING EASE POLICY FOR DRUG AND FOOD MSME BUSINESS ACTORS: A CASE STUDY IN EAST KALIMANTAN PROVINCE FROM 2018 TO 2023

R. Wulandari, Pranandari Kenyowulan, Marheni Juwitaningsih, Akhmad Kamaluddin Jaffar
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Abstract

The limited number of products registered with the Indonesian FDA by MSMEs is primarily attributable to their ignorance of the procedures involved in obtaining product authorization.  The Samarinda provincial office of the Indonesian Food and Drug Administration has launched the "Si Jebol" program, which assists MSMSEs in obtaining product authorization. This study aims to determine how the policy of ease of business licensure for pharmaceutical and food micro, small, and medium enterprises (MSMEs) affected product authorization in the province of East Kalimantan from 2018 to the first semester of 2023. This research methodology employs a descriptive qualitative analysis of secondary data obtained from the Samarinda annual reports of the provincial office of the Indonesian FDA. The findings indicate that the convenience of business licensing policy, which was executed by the Provincial office of the Indonesian FDA in Samarinda, effectively stimulates the issuance of product authorization permits. The obstacles encountered by MSMEs during the registration process for product authorization may serve as the foundation for future policies designed to assist MSMEs. Additional research on the challenges encountered by micro, small, and medium enterprises (MSMEs) is crucial in order to establish intervention strategies that the provincial office of the Indonesian FDA in Samarinda can implement.   Keywords: Indonesian FDA, Product Authorization, East Borneo, Policy, Micro Small and Medium Enterprise (MSME)
东加里曼丹省 2018-2023 年商业许可放宽政策的影响分析:2018年至2023年东加里曼丹省案例研究
中小微企业在印尼食品药品管理局注册的产品数量有限,主要原因是他们不了解获得产品授权的相关程序。 印尼食品与药物管理局三马林达省办事处推出了 "Si Jebol "计划,帮助中小微企业获得产品授权。本研究旨在确定 2018 年至 2023 年上半年,药品和食品中小微企业经营许可便利化政策对东加里曼丹省产品授权的影响。本研究方法采用描述性定性分析,对从印尼食药监局省办公室三马林达年度报告中获得的二手数据进行分析。研究结果表明,印尼食品与药物管理局三马林达省办事处执行的商业许可政策的便利性有效地刺激了产品授权许可的发放。中小微企业在产品授权注册过程中遇到的障碍可作为未来旨在帮助中小微企业的政策的基础。对微型、小型和中型企业(MSMEs)遇到的挑战进行更多的研究,对于制定印尼食品与药物管理局三马林达省办事处可以实施的干预策略至关重要。 关键词印尼 FDA、产品授权、东婆罗洲、政策、中小微型企业(MSME)
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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