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: , |

Keyter et al 2020 – Can standardisation of the Public Assessment Report improve benefit-risk communication?

Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as [...]

June 18th, 2020|Tags: , , |

Bujar et al 2020 – Documentation of Quality Decision-Making Practices

Background: Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into [...]

June 18th, 2020|Tags: , |

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 [...]

May 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 [...]

May 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 [...]

March 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 [...]

February 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 [...]

February 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 [...]

January 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 [...]

December 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 [...]

November 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 [...]

November 1st, 2019|Tags: |

Executive Colloquium report – What is the value and return on investment for our company to maintain a regulatory policy function?

In June 2019, the Centre for Innovation in Regulatory Science (CIRS) held an Executive Colloquium in Rockville, MD, USA that brought together representatives from multinational pharmaceutical companies to gauge [...]

October 17th, 2019|Tags: |

CIRS RD Briefing 73 – HTA outcomes 2014-18

Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure that patient access to medicines of therapeutic value is not delayed. As part of an [...]

July 10th, 2019|Tags: |

CIRS RD Briefing 71 – Trends in the regulatory landscape Latin America

To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Latin America are actively engaging in regulatorystrengthening [...]

July 9th, 2019|Tags: , |

CIRS RD Briefing 72 – Trends in the regulatory landscape Asia

To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Asia are actively engaging in regulatory-strengthening and [...]

July 9th, 2019|Tags: |

CIRS RD Briefing 70 – New approvals in six regulatory authorities 2009-18

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

May 13th, 2019|Tags: , |

Keyter et al 2019 – South African Medicines Control Council: Comparison of Its Registration Process

Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move [...]

March 14th, 2019|Tags: , , |

Bujar et al 2019 – Quality decision making in Health Technology Assessment

Background: To evaluate the quality of the decision-making processes of pharmaceutical companies during medicines development for evidence generation to support reimbursement of new medicines and the appraisal recommendation decision-making process [...]

March 4th, 2019|Tags: , |

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 [...]

January 31st, 2019|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: , , |

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 [...]

January 1st, 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: , |

CIRS RD Briefing 53 – Factors influencing drug roll out to six mature markets

Objective: To review NASs first launched between 2005‐2010 and to determine their regulatory status as of 31 December 2012 in USA, Europe, Japan, Canada, Switzerland and Australia to identify [...]

June 29th, 2014|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: , |

CIRS RD Briefing 51 – Submission lag time in the emerging markets

Lag Time (the time from which a product has been granted market authorisation in its first market to the time that its application is submitted for review by an [...]

August 29th, 2012|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: |

Liberti et al 2010 – Progress on the development of a benefit-risk framework for evaluating medicines

CIRS authors write about benefit-risk in the March 2010 issue of Regulatory Focus by the Regulatory Affairs Professionals Society (RAPS). Article reproduced with the permission of RAPS. Download [...]

March 1st, 2010|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 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 [...]

May 6th, 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 [...]

January 8th, 2020|Tags: , |

CIRS RD Briefing 73 – HTA outcomes 2014-18

Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure that patient access to medicines of therapeutic value is not delayed. As part of an [...]

July 10th, 2019|Tags: |

CIRS RD Briefing 71 – Trends in the regulatory landscape Latin America

To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Latin America are actively engaging in regulatorystrengthening [...]

July 9th, 2019|Tags: , |

CIRS RD Briefing 72 – Trends in the regulatory landscape Asia

To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Asia are actively engaging in regulatory-strengthening and [...]

July 9th, 2019|Tags: |

CIRS RD Briefing 70 – New approvals in six regulatory authorities 2009-18

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

May 13th, 2019|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 [...]

January 1st, 2018|Tags: , |

CIRS RD Briefing 53 – Factors influencing drug roll out to six mature markets

Objective: To review NASs first launched between 2005‐2010 and to determine their regulatory status as of 31 December 2012 in USA, Europe, Japan, Canada, Switzerland and Australia to identify [...]

June 29th, 2014|Tags: |

CIRS RD Briefing 51 – Submission lag time in the emerging markets

Lag Time (the time from which a product has been granted market authorisation in its first market to the time that its application is submitted for review by an [...]

August 29th, 2012|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: , |

Keyter et al 2020 – Can standardisation of the Public Assessment Report improve benefit-risk communication?

Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as [...]

June 18th, 2020|Tags: , , |

Bujar et al 2020 – Documentation of Quality Decision-Making Practices

Background: Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into [...]

June 18th, 2020|Tags: , |

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 [...]

May 19th, 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 [...]

March 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 [...]

February 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 [...]

February 3rd, 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 [...]

December 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 [...]

November 15th, 2019|Tags: , |

Keyter et al 2019 – South African Medicines Control Council: Comparison of Its Registration Process

Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move [...]

March 14th, 2019|Tags: , , |

Bujar et al 2019 – Quality decision making in Health Technology Assessment

Background: To evaluate the quality of the decision-making processes of pharmaceutical companies during medicines development for evidence generation to support reimbursement of new medicines and the appraisal recommendation decision-making process [...]

March 4th, 2019|Tags: , |

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 [...]

January 31st, 2019|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|

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 [...]

November 1st, 2019|Tags: |

Executive Colloquium report – What is the value and return on investment for our company to maintain a regulatory policy function?

In June 2019, the Centre for Innovation in Regulatory Science (CIRS) held an Executive Colloquium in Rockville, MD, USA that brought together representatives from multinational pharmaceutical companies to gauge [...]

October 17th, 2019|Tags: |