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KMID : 1142220160110020135
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 2 p.135 ~ p.145
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Analysis of Drug Approval System for Exporting Domestic Drug Products to International Market - Philippines
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Kwon Sun-Jin
Choi Young-Ju
Kim Hee-Sung
Cho Hea-Young
Kwon Jin-Won
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Abstract
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While the pharmaceutical market growth of developed countries is getting slow, pharma-emerging countries shows significant growth. Recently domestic pharmaceutical industry's interest has been diverted from generic/ domestic market to global market through developing new drugs. In this environment, this study aimed to investigate the drug approval system in the Philippines among pharma-emerging countries to contribute the diversification of drug export. This study is designed to appreciate differences on the drug approval systems between Philippines and Korea on the basis of the laws, regulations and expert advices. FDA Philippines emphasizes ethical & technical review by central Ethical Review Board (ERB) at the time of Investigational New Drug (IND) application. In New drug application (NDA), ASEAN Common Technical Documents (ACTD) or International Conference on Harmonisation (ICH)-CTD format are required to be submitted. For foreign drug manufacturer, cGMP is required and FDA Philippines has the authority to carry out inspections. The overseas manufactures which belongs to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) member countries would be waivered from the GMP inspection. In addition, due to the strick application of bioequivalence guideline, the bioequivalence data suitable for Philippines' guidelines should be prepared for the export of generics. FDA Philippines applies Periodic Safety Updated Report (PSUR) to the Monitored Release Products of new drugs/generics and Risk Management Plan (RMP) would be implemented in the near future. One of the things we need to pay attention to is that FDA Philippines does not allow Korean Pharmacopoeia (KP), and a separate analytical procedure/method validation is required for the ingredients which has KP standards. The stability criteria is also different from Korea, that is "Zone IVb(30oC ± 2oC, 75% ± 5%RH)". Such awareness and preparation for the differences on approval regulations between Korea and Philippines would lead to make the acquisition of approval more easier and contribute to export increase.
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KEYWORD
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Philippines, pharmaceutical drug approval, new drugs, generic drugs
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