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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
CIRS RD Briefing 69: Review of HTA outcomes and timelines 2014-2017
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 [...]
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 [...]
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 [...]
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 [...]