Regulatory

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: , , , |

A comparison of the Regional Medicines Regulatory Harmonisation Projects in East, West and Southern Africa.

During the DIA Global Annual Meeting 2023, Tariro Sithole, Nancy Ngum, Mercy Owusu-Asante, Stuart Walker and Sam Salek developed and presented a poster in which they shared the results, [...]

CIRS RD Briefing 88 – New drug approvals in six major authorities 2013-2022: Focus on orphan designation and facilitated regulatory pathways

This R&D Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the [...]

CIRS RD Briefing 87 – A Roadmap for Regulatory Strengthening: CIRS Tools for Measuring and Optimising Regulatory Performance to Support Practices in Line with the World Health Organization Global Benchmarking Tool Indicators

Over the last 20 years, CIRS has been developing regulatory science tools to increase transparency of processes, support quality regulatory decision making, and provide global advocacy in support of [...]

2024-04-12T09:05:02+00:00June 13th, 2023|Tags: , , , , , |

Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening

Background: Seven national medicines regulatory authorities in the East African Community (EAC) have embraced regulatory reliance, harmonization and work sharing through the EAC Medicines Regulatory Harmonization programme. Measuring the [...]

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the pharma industry

Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current [...]

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