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Why Convergence & Reliance Are Key To Managing The Challenges Of CMC Post-Approval Changes

 
• By Ian Schofield

Implementing post-approval changes (PACs) is a challenging business. Different countries have their own PAC requirements, approval times and classification systems, which can potentially cause or exacerbate drug supply shortages. In this article, a group of pharmaceutical experts led by Andrew Deavin of GSK tells the Pink Sheet about the concrete progress that is being made to address these problems.

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Cooperation helps to smooth the wheels of regulation • Source: Shutterstock

Efforts are under way to encourage the global regulatory convergence of requirements and the use of reliance among world regulators in the area of chemistry, manufacturing and control (CMC) post-approval changes (PACs).

Key Takeaways

Heterogenous requirements together with unpredictable review, approval and implementation timelines make it very difficult for the pharmaceutical industry and regulators to put post-approval changes (PACs) in place.

Duplication of effort, a backlog of PAC requests, and the risk of product shortages are among the problems experienced by industry and regulators.

Industry wants the use of regulatory reliance and convergence procedures to be increased at global level, including maximum review periods for PACs.

The ICH Q12 guideline is intended to make the management of PACs more predictable and efficient and to reduce the regulatory burden.

The COVID-19 pandemic and the introduction of regulatory flexibilities have led to a rethink of how PACs should be managed, particularly in emergency situations and for products of early access.

Pilot programs are under way in numerous countries and at global level to test the principles of regulatory reliance and convergence.

  • The International Coalition of Medicines Regulatory Authorities is exploring the feasibility of further collaboration and convergence among regulators regarding data expectations and assessment approaches.

Efficient and harmonized PAC management by all players is key to ensuring continuous supply in the best interest of patients.

Several pilot programs are currently being conducted to test both convergence and reliance principles as way of supporting the uninterrupted...

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