Publications2020-06-15T15:39:41+00:00

Publications

CIRS 2019 Annual Report

We're delighted to present the inaugural CIRS Annual Report, which provides a summary of projects and workshops undertaken in 2019, as well as a historical perspective of CIRS achievements [...]

August 25th, 2020|

An independent perspective on the East African Community Medicines Regulatory Harmonisation initiative

African regulators are taking bold transformative steps to optimise the effective and efficient use of their agency resources to assure access to quality, safe and effective medicines. In particular, [...]

August 18th, 2020|Tags: , |

Bujar et al 2020 – A Process for Evaluating Quality Decision-Making Practices

Background: The development of a medicine is not only underpinned by good science but also by Quality Decision-Making Practices (QDMPs). Indeed, it is important to ensure that all organisations [...]

July 15th, 2020|Tags: , , |

Rodier et al 2020 – Use of the CPP in 18 maturing markets

Background: The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing [...]

July 7th, 2020|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 [...]

July 22nd, 2018|Tags: , , |

Walker et al 2015 – Universal Framework for the Benefit-Risk Assessment of Medicines

A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, [...]

January 22nd, 2015|Tags: , |

Liu et al 2013 – Characterising Good Review Practices across APEC agencies

As a first step in the implementation of the Asia-Pacific Economic Cooperation (APEC) Best Regulatory Practice Project, the Centre for Innovation in Regulatory Science conducted a gap analysis survey [...]

December 1st, 2013|Tags: , |

Salek et al 2012 – Scorecards to Assess the Quality of a Regulatory Submission and Its Review

An efficient review depends not only on timely approval but also on ensuring the quality of the process from construction of the dossier to the ultimate regulatory decision. Two [...]

January 1st, 2012|Tags: |

Hirako et al 2007 – Comparison of the drug review process at five international regulatory agencies

Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has been developed to compare the regulatory review process [...]

January 22nd, 2007|Tags: |

An independent perspective on the East African Community Medicines Regulatory Harmonisation initiative

African regulators are taking bold transformative steps to optimise the effective and efficient use of their agency resources to assure access to quality, safe and effective medicines. In particular, [...]

August 18th, 2020|Tags: , |

Bujar et al 2020 – A Process for Evaluating Quality Decision-Making Practices

Background: The development of a medicine is not only underpinned by good science but also by Quality Decision-Making Practices (QDMPs). Indeed, it is important to ensure that all organisations [...]

July 15th, 2020|Tags: , , |

Rodier et al 2020 – Use of the CPP in 18 maturing markets

Background: The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing [...]

July 7th, 2020|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 [...]

July 22nd, 2018|Tags: , , |

Walker et al 2015 – Universal Framework for the Benefit-Risk Assessment of Medicines

A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, [...]

January 22nd, 2015|Tags: , |

Liu et al 2013 – Characterising Good Review Practices across APEC agencies

As a first step in the implementation of the Asia-Pacific Economic Cooperation (APEC) Best Regulatory Practice Project, the Centre for Innovation in Regulatory Science conducted a gap analysis survey [...]

December 1st, 2013|Tags: , |

Salek et al 2012 – Scorecards to Assess the Quality of a Regulatory Submission and Its Review

An efficient review depends not only on timely approval but also on ensuring the quality of the process from construction of the dossier to the ultimate regulatory decision. Two [...]

January 1st, 2012|Tags: |

Hirako et al 2007 – Comparison of the drug review process at five international regulatory agencies

Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has been developed to compare the regulatory review process [...]

January 22nd, 2007|Tags: |

CIRS 2019 Annual Report

We're delighted to present the inaugural CIRS Annual Report, which provides a summary of projects and workshops undertaken in 2019, as well as a historical perspective of CIRS achievements [...]

August 25th, 2020|