Position paper 10 December 2021

Optimising Post-Approval Change Management to Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide


Industry acknowledges its commitment to continue improving its strategic and predictive planning and proactive communication of changes to help facilitate global supply.

In addition, Industry believes that global regulatory convergence of post-approval changes to Marketing Authorisations (MAs) using science and risk-based approaches will enable a more efficient management of quality and supply improvements and will facilitate patients’ access to innovative medicines and vaccines.

National Regulatory Authorities (NRAs) should: establish national or regional guidelines in line with international standards (with regard to a risk based classification of changes and standardization of requirements); have clear procedural guidance including timelines; and implement reliance pathways to accelerate the approval of changes.

Key points and messages

  • Reliance, worksharing and recognition
  • Convergence of administrative and national requirements
  • Risk based and harmonised categorisation of PACs
  • PACs with defined approval timelines
  • Q12 tools: Post-Approval Change Management Protocol (PACMP) and the concept of Established Conditions (EC)
  • Defined common market implementation criteria
  • Health crisis preparedness plan
  • Industry efforts