Sithole et al 2020 – Evaluating the success of ZaZiBoNa

The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa [...]

2020-10-12T10:51:39+00:00May 19th, 2020|Tags: , , |

CIRS RD Briefing 75 – Emergency Use Pathways (EUPs)

It has become clear that agencies have a number of pathways that can be used during public health emergencies for the authorisation of therapeutics and vaccines. Some of these [...]

2020-10-12T10:51:21+00:00May 6th, 2020|Tags: |

Keyter et al 2020 – Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa

Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations [...]

2020-10-12T10:50:45+00:00March 25th, 2020|Tags: , , |

Mashaki Ceyhan et al 2020 – Patients’ perspectives of the pharmaceutical regulatory and reimbursement system in Istanbul, Turkey

The aim of this study was to explore patients’ knowledge and perspectives in Istanbul, Turkey about the pharmaceutical regulatory review and reimbursement processes with respect to access to new [...]

2020-10-12T10:50:27+00:00February 6th, 2020|Tags: , , |

Koyuncu et al 2020 – Evaluation of the performance of the Turkish regulatory agency: recommendations for improved patients’ access to medicines

Background: This study was to evaluate the Turkish regulatory review process and timelines between 2016 and 2018 with a view to assess the changes that had taken place since [...]

2020-10-12T10:50:10+00:00February 3rd, 2020|Tags: |

CIRS RD Briefing 74 – OpERA programme

CIRS has collected regulatory assessment data for over 20 years, initially with ICH and ICH-observing countries. The OpERA programme, “Optimising Efficiencies in Regulatory Agencies (OpERA)”, was initiated through CIRS in [...]

2020-10-12T10:49:09+00:00January 8th, 2020|Tags: , |

Keyter et al 2019 – Evaluation of the performance of the South African regulatory agency

Background Timely access to new medicines may be addressed through strengthening of registration efciencies and timelines by establishing and refning value-added registration processes, resources, and systems. The aims of this [...]

2020-10-12T10:48:48+00:00December 12th, 2019|Tags: , , |

Kühler et al 2019 – To what degree are review outcomes aligned for new active substances between the EMA and the US FDA?

Objective To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016. Design [...]

2020-10-12T10:48:30+00:00November 15th, 2019|Tags: , |

Project report – Monitoring implementation and adherence to ICH guidelines

Background: According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Articles of Association, the regulatory members of ICH are expected to implement [...]

2020-10-12T10:47:48+00:00November 1st, 2019|Tags: |