PDA Research: 2021 Post-Approval Change Issues and Impacts Survey (single user digital version)

Feb 2021
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The 2021 PDA Post-Approval Change Issues and Impacts Survey 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.

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    Format: PDF (1 file 1 MB)

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  • Table of Contents

    Table of Contents:

    Demographics of API Manufacturer Respondents
    Demographics of Drug Product Manufacturer Respondents
    Customization of APIS and Products
    Sourcing of Ingredients by Drug Product Manufacturers
    The Impact of ICH Guidance Implementation on Manufacturer's Ability to Manage Post-Approval Changes
    Types of Post-Approval Changes
    Experience with Specific Regulators
    Challenges of Regulatory Inconsistency
    Management of Post-Approval changes in the Pharmaceutical Quality System