Regulatory

Bujar et al 2019 – Reliability and relevance of a decision-making instrument

Introduction: The Quality of Decision-Making Orientation Scheme (QoDoS) was developed to provide organisations involved in submission, approval and reimbursement of new medicines with a tool to improve the quality [...]

2021-01-18T17:04:02+00:00January 31st, 2019|Tags: , , |

CIRS RD Briefing 68: Regulatory and HTA decision making and access to medicines – the consequences of sequence

Historically, every jurisdiction with some form of regulatory agency capacity has undertaken the review of medicines as a first step in the market access process. This step is intended [...]

2021-01-22T11:57:58+00:00August 1st, 2018|Tags: , , |

Wang et al 2018 – Building Synergy between Regulatory and HTA Agencies

Objectives: To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality [...]

2021-01-18T17:02:46+00:00July 22nd, 2018|Tags: , , |

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: |
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