Regulatory

CIRS RD Briefing 67 – New approvals in six regulatory authorities 2008-2017

Major improvements in the regulatory environment as well as changes in strategies of multinational companies have led to a decrease in the time to marketing authorisation as well as [...]

2021-01-22T12:09:19+00:00May 4th, 2018|Tags: |

CIRS RD Briefing 66 – Benefit-Risk Assessment Tool (BRAT)

A structured approach to benefit-risk assessment is required as the cornerstone of a consistent way to evaluate and communicate observations regarding a medicine’s benefit-risk profile. The Benefit Risk Action Team [...]

2020-10-12T10:43:13+00:00January 1st, 2018|Tags: , |

CIRS RD Briefing 65 – New approvals in six regulatory authorities 2007-2016

Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceutical companies have resulted in more new active substances (NASs) being internationalised, [...]

2021-01-22T13:35:36+00:00November 20th, 2017|Tags: |

Globally Applicable Facilitated Regulatory Pathways to Improve Equitable Access to Medicines

A variety of approaches have been developed to accelerate the regulatory review of medicines. We characterise these various expedited pathways as facilitated regulatory pathways (FRPs): regulatory pathways designed to accelerate [...]

2023-09-20T09:00:05+00:00July 19th, 2017|Tags: , |

CIRS RD Briefing 62 – New drug approvals in ICH countries 2007-2016

There have been major improvements in the regulatory environment in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the [...]

2021-01-22T14:02:40+00:00April 1st, 2017|Tags: |

Haqaish et al 2017 – Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore

Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, [...]

2021-03-29T14:37:33+00:00January 1st, 2017|Tags: , |

CIRS RD Briefing 59 – New approvals in six regulatory authorities 2006-2015

The last decade, 2006-2015, has seen a continuation of the convergence and general decrease in the approval times amongst six major regulatory authorities, namely the European Medicines Agency (EMA), [...]

2021-01-22T13:53:22+00:00May 16th, 2016|Tags: |
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