The availability of medicines is challenged by a variety of factors, one of which is global supply chain segmentation due to global regulatory hurdles imposed on product-related post-approval changes (PACs). The cGMPs require facilities and processes to be current, yet even for simple PACs it takes up to five years to get global approval for what will make the facility or process current.

PDA’s PAC iAM (Post Approval Change: Innovation for Availability of Medicines) program strives to identify, assess and address current barriers to implementation of post approval changes that are intended to ensure continued operations, drive innovation and continual improvement. Addressing these barriers will better ensure and sustain reliable global supply and availability of product to patients through the entire commercial lifecycle of a product.

PDA Research

2021 Post-Approval Change Issues and Impacts Survey

Experts' views on the most significant post-approval change issues faced by manufacturers of drug products and active pharmaceutical ingredients


Medicine and Vaccine Shortages: Role of Global Regulatory Complexity for PACs.

PDA PAC iAM 2017 Survey on Post Approval Change:

Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?

PDA Points to Consider: Technical Product Lifecycle Management Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities

PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System (PQS) Effectiveness for Managing Post Approval Changes

Webinar: Lifecycle Management: Updates and Insight on Post-Approval Changes, ICH Q12 Guidance and PAC iAM Activities

This webinar content is available to members only and discussed:

  • A status update and future forecast on post-approval guidance: ICH and FDA
  • Working definitions of Established Conditions
  • Results of the PDA PAC iAM Survey
  • Updates on PDA Technical Reports and other key initiatives meant to provide industry the tools to fully leverage upcoming regulations

PDA Journal Articles

Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) -Through Enhanced Science and Risk-Based Approaches Industry One-Voice-of-Quality (1VQ) Solutions

Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management

PDA Letter Articles

PDA Program to Address Post-Approval Hurdles: A Call to Action

The seamless delivery of high quality, effective and safe medicines to patients is the primary responsibility of every pharmaceutical company. Doing so, however, is by no means effortless.

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A Roadmap to Avoid Drug Shortages

Only by encouraging and adopting innovative manufacturing practices can an uninterrupted supply of drug product possibly exist. What is holding us back from innovating?

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PDA Supports Efforts to Encourage Manufacturing Innovation

Barriers to innovation during lifecycle management of a product are multiple. Recognizing the need for action, several international organizations are currently working toward the global convergence of regulatory requirements for PACs.

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PQS: An Effective Lever for Managing PACs

With sufficient product and process understanding and the use of quality risk management (QRM), certain PACs should be covered in the PQS (or only as a regulatory notification) with little to no prior approval by regulators.

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Workshop Presentations

Where is PDA playing an active role for ICH Q12?

Why PDA is involved and how we plan to help.

The Future State

Knowledge Management and Sharing to Reduce Regulatory Burden.

PAC iAM Technical Report Coming in Future

This report will describe how companies can practically use a risk-based approach to change management and include detailed examples using Post Approval Change Management Protocols (PACMP) and leveraging an effective Pharmaceutical Quality System (PQS).