Regulatory

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 [...]

2024-02-21T16:28:45+00:00February 21st, 2024|Tags: , , , , |

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: , , , |

Measuring time to market for new medicines in 7 Asian countries between 2016-21, following review by US FDA or EMA

During the DIA Global Annual Meeting 2023, Adem Kermad, Magda Bujar and Neil McAuslane developed and presented a poster in which they shared the results, recommendations and conclusions about [...]

2023-08-15T23:02:42+00:00August 15th, 2023|Tags: , |

Evaluation of the Effectiveness and Efficiency of Ten Years’ Experience with the East Africa Community Joint Assessment

During the DIA Global Annual Meeting 2023, Nancy Yang-Ngum developed and presented a poster in which she shared the results, recommendations and conclusions about the topic "Evaluation of the [...]

Evaluation of the Regulatory Review Process of the FDA Ghana: Challenges and Opportunities for Improvement

During the DIA Global Annual Meeting 2023, Mercy Owusu-Asante developed and presented a poster in which she shared the results, recommendations and conclusions about the topic "Evaluation of the [...]

2023-08-15T23:27:14+00:00August 15th, 2023|Tags: , , |

Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority

During the DIA Global Annual Meeting 2023, Lorraine Danks, Boitumelo Semete-Makokotlela, Sam Salek and Stuart Walker developed and presented a poster in which they shared the results, recommendations and [...]

2023-08-15T23:22:57+00:00August 15th, 2023|Tags: , , , |
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