Trends, challenges and priorities
Progressing the regulatory vision
In 2021, the team gained further knowledge and understanding of the emergency use authorization processes and discovered the possibilities for sustaining different products post Covid-19. Examples include the use of post-approval change management protocols (PACMPs) that have been included in some of the Covid-19 vaccines and therapies for global use; PACMPs are described in the Chinese Health Questionnaire 12 (CHQ12) as one of the tools available for the simplification of post-approval changes.
BioPhorum Regulatory continues to focus on the implementation of our vision. One element of BioPhorum Regulatory is to support workstreams to implement and design regulatory technical changes. We encourage workstreams to collaborate with standards organizations, other industry groups and regulatory agencies to promote BioPhorum’s changes to global industry standards.
We have embarked on a new path since the start of 2021, by creating our own deliverables through the support we offer to cross-phorum initiatives on the global implementation of in-line monitoring and real-time release (ILM/RTR) and raw materials. Additional pieces of work delivered this year include the review and feedback to agencies or standards organizations on multiple guidance or draft monographs. The team has embarked on the transformative journey to ‘one standard’ through an initiative aimed at pharmacopeial harmonization.
Our work is always very cognoscente of the global aspect of our members products and work with the FDA, EMA, JDA requirements and other organizations that provide a global regulatory view. We promote and encourage harmonization through cross-phorum initiatives.
In 2021 we have facilitated training within BioPhorum, to ensure the businesses are is aware of the necessary processes and armed with knowledge of the regulatory and standards environment in which they operate in, this will impact innovation and drive opportunities. We are working on the raw materials cross-phorum initiative to promote the use of regulatory tools to build in our members regulatory files to support flexibility of supply, which has been an important issue for years, but came to the forefront of concerns during the pandemic. Through the proposal for change, we encourage members to demonstrate the understanding of raw materials in their regulatory applications and provide evidence of enhanced quality to national health agencies. We use quality by design tools and ICH Q12 guidelines published in 2020 to ease the delays prior to implementation due to regulatory review and approval.
We are supporting the global implementation of ILM/RTR, which is a significant change for manufacturing processes that are likely to be reflected in the registration pathways. There is currently limited information, guidance, or standards for the implementation of ILM/RTR for biologics, specifically from a regulatory point of view. We are working in conjunction with the ILM/RTR team to understand the changes needed in technology, point of analysis, infrastructure, and controls to define how these are reflected and presented to regulatory agencies, in regulatory submissions, and during regulatory inspections so that processes and products are accepted by regulatory agencies.
BioPhorum Regulatory encourages dialogue with standards organizations and regulatory agencies and drives alignment across industry viewpoints and regulatory expectations. This is exemplified by the team’s recent comment on an USP protocol for the collection of additional data for the addition of a new method to detect endotoxins in parenteral drugs.
Regulatory deliverables 2021
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