의약품 허가 규제 국제 협력에서의 허가참조제도

초록

This study sought to understand the current regulatory collaboration practices of reference country systems inselected countries. The study included eight countries, namely; Nigeria, South Africa, Malaysia, Vietnam, Singapore,Indonesia, Switzerland, Mexico, and two alliances;, namely European Union and ACCESS consortium. The latest data onthe reference country systems in the selected countries were collected and analyzed. The reference regulatory authoritiesinclude (1) internationally recognized countries (e.g., Stringent Regulatory Authority, SRA), (2) internationally recognizedcollaborations (e.g. Pharmaceutical Inspection Co-operation Scheme), (3) internationally recognized programs (e.g., WHOPrequalification), and (4) mutual recognition between countries. The SRA is the most frequently mentioned reference inunilateral reference systems, which are not based on mutual recognition. A reference country system could affect regulatoryprocesses in two ways; either by countries requiring market approval from a reference country as a condition for a newapplication or by reducing the period of review if an applicant submits an assessment report and relevant data reviewedby a reference country. The European Union Mutual Recognition has resulted into efficient work-flow among memberstates, and similar international alliances are emerging. Of these, the ACCESS consortium is seeking the possibility of anew collaboration not based on geographical region, in contrast to regional collaboration, which seems seclusive to worksharingamong nonequivalent member states.

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