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

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.