Expert Commentary: Diverse Meanings of Regulatory "Convergence"

The term regulatory "convergence" is apparently given many meanings in the field of medical products. Originally defined as a process of making regulatory requirements similar across countries, the term can now mean regulatory similarity of any degree, sometimes mixed with regulatory cooperation of almost any kind among countries. More concretely, the term can refer to regulatory authorities' complete or incomplete adoption of global guidelines, joint review/inspection of the dossiers or facilities with other regulatory authorities, accepting other authority's decision critically or uncritically, or any combination thereof. While the term has introduced a useful notion, the acquired ambiguity is causing a certain confusion in the discussion. This article tries to clarify the term's meanings in different contexts and resolve confusions. By going deeper than "convergence" to identify the elements that matters, the regulatory authorities, inter alia, should be able to formulate a more conscious and effective strategy on global medical product regulations.