Lost In Translation? Japan’s GMP Compliance Dilemma
Executive Summary
As Japan tightens regulations for good manufacturing practice, some members of the domestic pharma industry, including one inspector, are recognizing the need for official translations for foreign companies, which the ministry denied a year ago and continue to present challenges.
You may also be interested in...
India-Japan Partnering Momentum: Regulatory Alignment Is Key
Biopharma executives from India and Japan discuss the need for enhanced “alignment” on the regulatory front, including exploring the possibility of a mutual recognition agreement as the two nations seek to expand biopharma partnering efforts and also build supply chain resilience.
A Year's Struggle: How Japan Is Recovering Damaged Generic Supplies After Quality Violations
Japan struggles to recover its ever-expanding supply chain for generic drugs after several key players had their production stopped because of a series of GMP violations. As the share of generics grows under government policy, some in the industry argue the problems are deeply rooted in a decades-old pricing system.
Kaketsuken Scandal Prompting Japan Regulatory Tightening
Major Japanese vaccines and blood products producer Kaketsuken is sinking ever deeper into a major manufacturing and data falsification scandal it has emerged stretches back more than 40 years, prompting discussion of official administrative sanctions and possibly criminal proceedings and moves to strengthen regulatory oversight.