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KMID : 1142220170120010051
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 1 p.51 ~ p.58
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Indonesia Regulatory System : How to Register Domestic Drug in Indonesia
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Sohn Ji-Young
Choi Tae-Myung
Choi Young-Ju
Kim Hee-Sung
Lee Eui-Kyung
Kwon Jin-Won
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Abstract
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The market expansion through exports is very important due to astronomical amount of money for the development of new drug. The first step in exporting the medicines is to be approved by the regulatory agencies, and understanding the country’s regulatory approval system may be the basis for the exports. Based on the webpage of the National Agency of Drug and Food Control (NADFC) and related laws, we researched and reviewed the Indonesian pharmaceutical regulatory system to contribute to the promotion of the Korean pharmaceutical companies’ exports to Indonesia. The market authorization requires a different set of documents for the approval of the new drugs and the generic drugs. For the application of the new drug, full dossiers in the format of the International Council on Harmonization-Common Technical Documents (ICH-CTD) or ASEANCTD (ACTD) were required. But, generic drug needs generic dossiers in the format of only ACTD. The valid period of the market authorization is 5-year and should be renewed every 5 year. The validity periods of the GMP certification in Indonesia is also 5-year, and it is mutually recognized among ASEAN 10 countries. Indonesia has pharmacovigilance and risk management system, and requires to report all adverse drug reaction (ADR) or adverse drug events (ADE). Product Safety Update Report (PSUR) should be reported regularly by 5 years (i.e. every
6 month during first 2 year and annual report during 3-5 year) from product launch. The stability test condition corresponds to Zone IVb(30 ± 2oC, RH 75 ± 5%) different from Korean stability guideline condition (Zone II : 25 ± 2oC, RH 60 ± 5%). In addition, it is needed to follow the HALAL laws as Indonesia is a representative Islamic state. It is worth considering to establish the pharmaceutical factories to continue selling the medicines within Indonesia because it gives benefit for review period and renewal. This research will give the useful information to the Korean pharmaceutical companies which make inroads into Indonesian market by comparing the Indonesian regulatory with the domestic system.
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KEYWORD
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Indonesia, approval application, regulatory system, new drug, generic
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