This workstream strives for harmonization of post-approval changes through direct interaction with regulatory agencies. The aim is to consolidate industry opinion and encourage the adoption of WHO guidelines and ICH principles.
Complexity is a burden
WHO and ICH guidelines are not universally adopted. The same change may be assigned a different change category and will require different data packages, depending on local regulations. Complexity is a burden, regulatory frameworks for PAC, often differ significantly from WHO guidelines, this results in:
- Delays – For patient access, to market, or the manufacturer. Slow approval process and high cost to make change
- Long lead time for change (from initiation to implementation)
- Market fragmentation and parallel manufacture
- Process improvements are delayed and discouraged
- Principle of reliance between agencies cannot be applied
The team aims to be the consolidated opinion of the industry to trade bodies and regulatory authorities for changes post license by market and encourage the adoption of WHO guidelines and/or ICH principles for harmonization of regulatory requirements for PAS changes. This will accelerate the implementation of changes across the markets, reduce market fragmentation and supply chain complexity, reduce the number of different submissions or increase the efficiency of the submission process and increase the efficiency of the review and approval process by agencies resulting in improved compliance and fewer investigations related to raw materials.
Post-Approval Strategy deliverables
More related workstreams
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.
To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.