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KMID : 1142220180130010035
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 1 p.35 ~ p.43
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Thailand Regulatory System : How to Register Domestic Drug in Thailand
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Yoon Keun-Yeong
Kwon Jin-Won
Lee Eui-Kyung
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Abstract
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The growth rates of traditional developed countries of the pharmaceutical industry continue to slow down while those of pharmerging countries are experiencing a rapid growth. Korean pharmaceutical countries are starting to promote export and expansion into the overseas market as the concluded FTAs with other countries result in market opening and the prices of their pharmaceutical products are being reduced in the domestic market. Consequently, the need to understand the regulatory system that is different for each country is ever more increasing. Thailand is the second largest market after Indonesia in Southeast Asia whose healthcare demand is increasing and the governmental spending on healthcare is relatively high compared to other countries in the region. This study focuses on the regulatory system of Thailand for pharmaceutical products by comparing it with that of Korea to promote export. In Thailand, regulatory documents should be submitted in the form of ASEAN CTD (ASEAN Common Technical Document). In order to conduct clinical trials in Thailand, review and approval by the IEC (Independent Ethics Committee) are mandatory whose requirements, timeline and administrative procedure are different for each IEC. In addition, investigational new drugs have to go through the import procedure after IEC approval. NDA (New Drug Application) is applied through the Central Queue Reservation System, where the applicant submit the power of attorney together with the documents required for using the system to to reserve a queue, the date of which is fixed for each type of drug and the preliminary review takes place on the reserved date. There is no legal basis for renewal of marketing authorization and the license for manufacture and import of drug persists. Also, there are no legally binding regulations related to DMF or pharmacovigilance in Thailand. Korea-ASEAN FTA is in effect since the June of 2007 and Thailand is one of the ASEAN countries. Since the pharmaceutical market of Thailand relies heavily on import and possess a great potential as mentioned earlier, export to the country is recommended and it would provide a good basis for entering other markets of the ASEAN countries as well.
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KEYWORD
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Thailand, pharmaceutical products, regulatory system, approval, clinical trials
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