The Development of Registration System Model to Expedite Approval of Biological and Herbal Medicinal Products Researched and Manufactured in Thailand for National Security and Exportation

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Prapon Aungtrakul
Winid Ausawadkidwiree
Worasuda Yoongthong
Ananchai Asawamekin
Wasamon Ondee
Kornkanok Neadtip

Abstract

Drug registration system for undergone research and drug development is not effectively facilitate national research and development especially for herbal and biological drugs. Consequently most locally researched products have failed to be registered and marketed. Therefore we conducted the descriptive action research to develop registration system model to expedite approval of biological and herbal medicinal products researched and manufactured in Thailand. The model was designed by incorporating the scientific advice system with current drug registration system. We tested the model by conducting scientific advice for pilot products under research development. We found that criteria, laws and regulations are the key problems of the registration of herbal products under research development and in urgent need to be revised.  The revision of product classification system and guidelines for herbal product registration are highly important to suit product development. For biological products, the official technical registration guidelines of specific products researched for local manufactures are key priorities in order that prouct development will be in line with the requirements. The regulatory pathway should also be revised in accordance with international system.                The effective registration system model for products under development consists of three key components. The first one is the product classification system timely developed in accordance with advance in technology and research. Secondly the scientific advice system for drug products under development serves as a key mechanism for continuing development of the overall registration system based on the ongoing problems of products under development. Lastly the registration system and stepwise approach for products under development are necessary together with necessary technical guidelines.                 Administratively, we constructed the supportive system by setting the administrative unit within Bureau of Drug Control to provide the consultation on development of pre-marketing registration. Then we extended to overall herbal products by establishing the new administrative unit in Thai FDA called “Pilot office for evaluation and registration of herbal and researched health products" in order to strengthen the scientific advice and stepwise registration system including the development of laws and regulations. Further studies should be conducted to strengthen the drug control system to meet WHO standard functions of national regulatory authority as well as reconsideration regarding the human resource development and budget, to make this system sustainable.

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รายงานการวิจัย