의료제품 국제규제협력의 발전과 국제규범화에 대한 연구

Overcoming the international public health crisis known as COVID-19, it was realized that better access to medical products could have been achieved with international regulatory harmonization. International regulatory cooperation for medical products has evolved in response to globalization, technological development and increasing complexity of supply chains. As national regulatory authorities ensure safe, effective and quality medical products under their own national laws and regulations, their international regulatory cooperation has taken a voluntary and flexible form rather than a formal negotiation for legally binding agreements. Furthermore, as regulating medical products requires a certain level of regulatory system and resources, regulatory cooperative mechanisms such as ICH, GHTF were launched initially among the advanced countries. These mechanisms facilitated information exchange and developed standards and guidelines, thereby laying the groundwork for international harmonization and convergence. As global supply chains become more complex and innovative technology advances, these cooperative mechanisms became more responsive, expanding the membership to developing countries, broadening scope of topics addressed and modernizing their structure. However, their regulatory cooperation is still voluntary basis and flexible as final decision-making remains within each national authority. Accordingly, international regulatory cooperation resulted in a limited binding rules. Nonetheless, it is noteworthy that some outcomes discussed and developed in regulatory cooperative mechanisms have been incorporated into legally binding trade rules. Recently concluded CPTPP and USMCA reflect documents and instruments developed by the regulatory cooperative mechanisms from ICH and GHTF. Mutual recognition agreements for pharmaceutical good manufacturing practices(GMPs) are considered as trade agreements and some of them incorporate PIC/S standards and guidelines. Although the coverage of those incorporated rules is limited to specific areas such as GMP or technical documents, it should be noted that international regulatory cooperation developed basis for a rule-setting for trade agreements and become a part of them.