Post-Approval Changes Without Losing a Year

Post-approval changes (PACs) keep products current, yet unclear global impact

assessments can add months to every update. Different markets, different rules,

and no central playbook create chaos.

This guide streamlines PAC management. You will build a global impact matrix,

standardize documentation bundles, orchestrate timelines, and monitor progress so

changes move in parallel without sacrificing compliance.

Why coordinated PACs matter

• Regulatory compliance: Authorities expect timely, accurate updates after

changes in manufacturing, quality, or labeling.

• Supply continuity: Delayed approvals can stall production or distribution in

key markets.

• Portfolio agility: Efficient PACs let you implement improvements faster and

stay competitive.

• Resource efficiency: Structured processes reduce duplicate work across

regions.

Step 1: Create a global impact matrix

• Map change types (equipment, process, specification, labeling) to regulatory

categories by region (variation types, CBE, PAS, NDS amendments).

• Record required documentation, testing, and data for each region.

• Include typical agency timelines, fees, and special considerations.

• Assign owners for matrix maintenance and update whenever regulations shift.

• Provide search and filter functionality so teams can quickly assess impact.

Step 2: Standardize documentation bundles

• Build modular packages containing comparability rationales, validation summaries,

stability data, risk assessments, and quality justifications.

• Maintain templates for regional Module 1 cover letters, forms, and translations.

• Store bundles in a controlled repository linked to the impact matrix for quick

reuse.

• Capture lessons learned from previous submissions to refine content.

Step 3: Plan parallel submissions with coordinated timelines

• Develop project plans that align CMC activities, supply chain readiness, QA

sign-offs, and regulatory submissions.

• Identify dependencies (e.g., US approval before EU submission) and build

contingency plans.

• Visualize timelines with Gantt charts and dashboards to track progress across

markets.

• Schedule regular cross-functional check-ins to adjust resources when priorities

shift.

Step 4: Align change control and regulatory workflows

• Integrate change-control systems with the impact matrix so regulatory

assessments occur early.

• Require regulatory input before change approval for high-impact items.

• Trigger automated tasks for dossier updates, translations, and partner

notifications.

• Track status from change approval through submission and agency decision.

Metrics that prove your PAC process works

• Cycle time from change approval to first submission and to global completion.

• Number of late submissions versus planned timelines.

• Reuse ratio of documentation across regions.

• Agency queries and deficiency rates related to PACs.

• Supply delays linked to regulatory timelines.

45-day roadmap

1. Days 1-10: Review recent PACs to identify bottlenecks and data gaps.

2. Days 11-20: Build the initial global impact matrix, validate with regional

leads, and publish guidance.

3. Days 21-30: Refresh documentation templates, align with QC/CMC, and

populate for the next priority change.

4. Days 31-45: Launch coordinated timelines, host cross-functional planning

meetings, and track progress with dashboards.

Frequently asked questions

• Should we submit in parallel or sequentially? Parallel where regulations

allow. Document dependencies and adjust when specific markets require prior

approvals.

• How do we keep the matrix current? Assign regional owners, conduct quarterly

reviews, and subscribe to regulatory intelligence feeds.

• What about local affiliates? Provide matrix access, require feedback on

country nuances, and track acknowledgment of updates.

• How do we manage documentation translations? Use controlled glossaries,

translation memory, and align translation timelines with submission waves.

Sustain the win

Hold monthly PAC coordination calls, refresh the matrix whenever regulations shift,

and rotate ownership of documentation templates. Celebrate on-time PACs to

reinforce discipline. With a coordinated approach, you can implement improvements

without losing a year.