The ICH-M4Q guidance has not been reviewed for 20 years: the upcoming review by the International Council for Harmonisation (ICH) will all allow for new modalities and technologies to be incorporated into the guideline. Given the long review periods, it is essential the biopharmaceutical industry voice is heard in order to future-proof the guidelines to support innovations in manufacturing and analytical processes.
Our workstream will focus on three deliverables:
- comments and feedback to ICH when the review is announced;
- creation of a summary paper that will capture the challenges, risks and benefits of implementation;
- creation of a case study for a single modality, illustrating how the new guidance impacts upon regulatory approval for that modality
These deliverables will help us work towards our strategic objective of harmonization. New ways of working, for example, the mature approach to definition of product quality (as defined in other ICH guidelines) are not part of the current version, leading to divergence in implementation and regulatory expectations. Regional and national requirements lead to different submissions for different markets are a particular pain point, these lead to non-value-adding activities for regulatory professionals as they adapt dossiers for different markets. The ease of post-approval changes (implementation of ICH Q12 and ICH Q14), and advances in the digitalization of dossiers (industry and agencies lead) are further benefits expected to impact heavily on the industry via this review.
Additional industry goals which will be realized are:
- Compliance with regulatory expectations, even for future modalities, future technologies and ways of working
- The new guideline will offer new regulatory tools that will ease the submission process and lifecycle management changes, the Regulatory CMC Phorum discussions and summary document will allow members to implement these ASAP
- The BioPhorum feedback at the forefront of innovation will allow easier adoption of new and unique technologies, benefiting from modalities focused discussions. Aligning with future submissions strategy and anticipating data structure (KASA for example), being 21st century aligned and driven.
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Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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