About Mark Salangsang

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So far Mark Salangsang has created 12 blog entries.

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 [...]

2020-11-19T13:40:55+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: , |

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 [...]

2020-10-12T10:46:20+00:00July 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 [...]

2020-10-12T10:46:00+00:00July 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 [...]

2020-10-12T10:45:27+00:00July 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 [...]

2020-10-12T10:45:09+00:00May 13th, 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 [...]

2020-10-12T10:44:12+00:00March 4th, 2019|Tags: , |