DIA Middle East Regulatory Conference

Post-approval changes (PAC) to the registered information of authorised medicinal products are introduced routinely worldwide to enhance the robustness and efficiency of the manufacturing process; improve quality control techniques; respond to changes in regulatory requirements; and upgrade to state-of-the-art facilities. The regulatory landscape for PAC varies dramatically across health authorities globally, also within the Middle East region countries have variable regulations with regard to requirements and approval timelines for changes. Implementing simple changes globally can take up to 5 years. There is a need to globally harmonize the post approval regulations to ensure continuous supply of high quality, compliant drugs to patients globally with a flexible supply chain. ICH and WHO are taking a leading role to establish key concepts that can be leveraged globally to drive global regulatory convergence regarding regulatory requirements for PACs. The session will explore the current landscape for PACs globally and specifically in ME, the challenges being faced and recommendations for improvement.