Benefits to State
CRS can help CARPHA / CARICOM Member States to:
- Reduce the amount of resources needed to review medicines for market registration and/or import approval.
- Identify safety and quality issues that may need monitoring and action.
- Realign staff functions to increase efficiencies and/or expand scope of work.
Benefits to Industry
Through the CRS, market authorization holders can:
- Apply for market entry among CARPHA Member State markets of over 17 million people.
- Use a streamlined process for review, particularly for countries without a formal process.
- Experience faster market access, particularly for WHO Prequalified medicines and vaccines.
- Submit case reports of suspected adverse reactions and quality issues for countries without reporting systems.
How we do it?
The CRS supports CARPHA Member States’ marketing authorization functions by:
(i) reviewing and recommending medicines and vaccines, using regulatory reliance, and
(ii) by maintaining a network for regional pharmacovigilance (VigiCarib), to report medicines related adverse events and substandard and falsified products to Member States and global monitoring systems.