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PDA has just released the 2021 PDA Post-Approval Change Issues and Impacts Survey, which provides experts’ views on the most significant post-approval change issues faced by manufacturers of drug products (DPs) and active pharmaceutical ingredients (APIs). By understanding the challenges that industry faces in making manufacturing changes to products after the initial regulatory approval, regulators and industry together can develop effective solutions and prioritize the issues with greatest impact on global operations. This comprehensive survey includes data on:
- Customization of APIs and drug products for different markets and customers
- Sourcing of ingredients by DP manufacturers
- The impact of ICH guidance implementation on the manufacturer’s ability to make post-approval changes
- The types of post-approval changes typically made
- The challenges presented by inconsistencies in how regulators treat post-approval changes
- Respondents’ experience with specific regulators
- Management of post-approval changes within the pharmaceutical quality system
The survey was conducted in July 2020. The report includes data on 106 diverse respondents who manufacture all types of DPs and the APIs for each and manufacture and market products in all marketable continents. You can purchase this survey for $325 at any time. Click to purchase or gain access to a free person digital copy when you join PDA by 11 March 2021 for just $279. When you become a PDA member, you will also gain on-demand access to view the entire online library of more than 80 peer-reviewed Technical Reports.