ISPE has launched this program to catalyze consistent and harmonized interpretation and implementation of ICH guidelines with the intention of improving patient access to innovative medicines and technology.
Why Are We Doing This?
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. Rather than the adoption of globally harmonized regulatory criteria, localized interpretations of ICH guidelines have resulted in widely different regulatory expectations that have forced companies to adopt multiple control strategies for a single product using the same manufacturing process globally , or worse, diluting the control strategy toward the most conservatively harmonized common denominator.
The initiative will focus on identifying barriers to interpretation and implementation of ICH guidelines with respect to progressing the introduction of new technology for development, manufacture, lifecycle management, and distribution of pharmaceutical products and innovative medicines and promote efforts to establish durable globally harmonized regulatory process implementation and guidance.
Activities generally in scope for this initiative:
- Conducting research, data gathering to illustrate what happens when there is lack of harmonization (complement to the IQ paper)
- Publishing white papers, convening industry/regulatory roundtable discussions
- Sponsoring sessions or workshops to share industry and regulatory experience and engage in discussions to progress improvements in implementation globally of innovative technology.
- Providing training programs for industry as well as regulatory inspectors and assessors.
- Acting as a potential focus for companies in the post approval ICMRA pilot to share experiences and benchmark, as well as companies who have had experiences attempting to introduce new technology?
As a first phase of this initiative, ISPE is conducting a survey to gather data on the extent and severity of challenges/barriers globally in developing and implementing innovative technologies, from which specific solutions will be sought to enable innovation in the future.
What Will Success Look Like?
The ultimate success of this initiative will be when similarly situated innovative technology is routinely and consistently assessed and accepted globally by regulatory authorities whether introduced during development via investigational applications, in commercial marketing applications, or as post authorization/approval lifecycle continuous improvement opportunities. However intermediate incremental success factors include:
- Positive acknowledgement from global regulatory authorities on the merit of the proposal and recommendations developed from this initiative.
- Advancement of regulatory programs in accordance with the conceptual recommendations developed from this initiative.
- Demonstrated regulatory acceptability for innovative technology across regions representing ICH member countries.
How You Help
- Complete the survey & encourage others to complete survey
- Contact the initiative team with case studies.
For More Information
The Enabling Pharmaceutical Innovation: Delivering for Patients initiative and survey are conducted under the auspices of ISPE’s Regulatory Steering Committee (RSC). For any questions concerning the survey or for more information, please contact Carol Winfield, ISPE Sr. Director Regulatory Operations at CWinfield@ispe.org.