New Initiative Seeks to Back up ICH's Harmonization Mission
07 May, 2024
The International Society for Pharmaceutical Engineering (ISPE) has recently released a survey report aimed at understanding barriers to innovation in the pharmaceutical industry, with a focus on regulatory harmonization. ISPE’s report, titled "Enabling Pharmaceutical Innovation: Delivering for Patients," highlights key insights from nearly 400 industry representatives on this topic.
In an interview with Bioprocess Online, Roger Nosal, chair of the initiative, has weighed in on the survey's findings and the initiative's objectives, emphasizing the importance of industry-regulator cooperation in shaping the pharmaceutical landscape.
Enabling Pharmaceutical Innovation: A report on the Barriers to Innovations Survey
During the last decade, industry has experienced a proliferation of regulatory divergence with respect to the interpretation and implementation of ICH guidelines (and control strategies) across geographic regions. In 2023 ISPE conducted a survey to gather data on the extent and severity of challenges/barriers globally in developing and implementing innovative technologies. The Report on the Barriers to Innovation Survey contains survey background, summaries of findings, conclusions and recommendations, and a discussion of next steps. Complete survey results are included in an Appendix.
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