Regulatory

CIRS RD Briefing 92 – Appraising the usability of public assessment reports for reliance

Regulatory reliance facilitates regulatory approvals, allows the use of resources more efficiently, and ultimately serves patients by accelerating access to quality-assured, safe, and effective medicines. The World Health Organisation [...]

2024-05-31T08:07:57+00:00May 29th, 2024|Tags: , , |

Improving development, regulatory and reimbursement frameworks for rare disease products

This multi-stakeholder workshop consisted of a series of presentation sessions and three parallel breakout discussions. Presentations explored trends in regulatory and HTA approvals of orphan products [...]

CIRS RD Briefing 91 – Approaches to Implementing Regulatory Reliance: Considerations for Agencies

This CIRS briefing delves into the increasingly pivotal role of regulatory reliance in the global pharmaceutical landscape. Reliance is defined by World Health Organization (WHO) as the act whereby [...]

CIRS RD Briefing 90 – Challenges and opportunities for orphan medicines availability in Mexico

The document ‘Estrategia sobre Certidumbre Regulatoria para el Sector Farmacéutico’ (Strategy of Regulatory Certitude for the Pharmaceutical Sector), published last January by COFEPRIS describes important working projects the agency [...]

2024-02-12T12:09:15+00:00November 1st, 2023|Tags: , , , |
Go to Top