In this workshop, CIRS brought together regulators, pharmaceutical companies, academics and non-profit organisations to discuss success factors for strengthening regulatory systems to support the implementation of collaborative models.

This two-day workshop consisted of a series of sessions featuring presentations and panel discussions, as well as three parallel breakout discussions. The workshop synopsis summarises key messages and recommendations from the presentations and breakout discussions.

Workshop objectives:

  • Identify the critical success factors and activities that agencies need to put in place to strengthen their regulatory systems for the registration of medicines and how this is being carried out at a jurisdictional (national) level and through regional work-sharing initiatives.
  • Discuss the opportunities, challenges and lessons learned from current initiatives and practices that enable jurisdictions and regional work-sharing initiatives to move from concept to practical implementation.
  • Make recommendations on how jurisdictional system strengthening and regulatory collaboration can drive continental models across agencies and improve medicines availability for patients globally.

Key success factors for strengthening regulatory systems to support the implementation of collaborative models, as identified from the workshop:

Jurisdictional regulatory strengthening

Regulators need autonomy, strong frameworks, and leadership commitment for effective collaboration, supported by tools like the WHO GBT and CIRS OpERA toolkit.

Measuring impact

Metrics are crucial for measuring regulatory performance, improving transparency, and achieving higher maturity levels, as well as refining collaborative models.

Quality decision making

Decision-making tools enhance the quality and justification of regulatory decisions, leading to more efficient reviews.

Reliance and work sharing

Risk-based approaches, such as reliance on information from comparable regulators and work sharing, can improve regulatory efficiency and reduce costs.

Digital solutions

Digitisation and AI integration are necessary for improving regulatory efficiency and transparency.

Front cover of the synopsis from the CIRS Regulatory Collaboration and System Strengthening Workshop in Johannesburg in February 2025
Download Workshop Synopsis