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.

Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents.

Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012.

Competitive Strategies for Japanese Clinical Trial Sites: A New Approach to Quality.

In Japan and other major East Asian countries in the global drug development scene, trial sites play a major role in conducting clinical trials by intervening between sponsors and investigators. The recent globalization of clinical development has been intensifying competition among the regions, trial sites, and investigators in terms of cost, speed, and quality. The quality of clinical trials-the key factor for competitiveness-is now being defined with a risk-based approach.

The ICH, the GHTF, and the Future of Harmonization Initiatives.

Comparison of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Global Harmonization Task Force (GHTF), the global regulatory harmonization initiatives in the field of drugs and medical devices, respectively, reveals that "harmonization" activities contain several categories. It was also found that the target level of harmonization (ie, that of technical regulatory requirements and that of regulatory processes) greatly affects the implementability of final work products. Those products concerning regulatory processes (most of the GHTF Documents) often require legal changes and are more difficult to implement than those regarding technical requirements (all of the ICH Guidelines), usually implementable by regulatory authorities publishing them as nonbinding suggestions.

International vision and strategy for drug regulatory authority: the PMDA's international vision.

The past several years saw various countries' drug regulatory authorities (DRAs) internationalizing their activities in response to the rapid globalization of pharmaceutical affairs. This is the second surge of internationalization, coming after the first in the 1990s, when the International Conference on Harmonisation (ICH) and the Global Harmonization Task Force were founded. For maximum effect, a DRA needs to carefully strategize its international activities.