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.
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Initiatives from regulators around the world seek to promote regulatory reliance at global level.
As medicines agencies increasingly turn to worksharing and other mechanisms to reduce duplication of effort, the Access Consortium has thrown its weight behind the use of reliance processes for national good manufacturing practice inspection outcomes.