December 2019 Slide of the Month
December's Slide of the Month is taken from a CIRS poster recently presented at ISPOR Europe 2019. Does FDA Breakthrough Designation affect HTA recommendation in terms of timing and outcome? [...]
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 [...]
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 [...]
McAuslane et al 2019 – Confluence of Accelerated Regulatory and HTA Access Pathways
There is a growing interest in aligning accelerated regulatory pathways with flexible access and reimbursement pathways to expedite the equitable availability of high-quality, safe, and effective medicines that provide [...]
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 [...]
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 [...]
2018 Forum report – Managing uncertainties for products using early access pathways
In November 2018, a collaborative forum presented by CIRS and the Utrecht University WHO Collaborating Centre for Pharmaceutical Policy and Regulation brought together regulatory, HTA, industry and academic perspectives [...]
2017 Workshop report – Flexible regulatory/access pathways
The aim of this workshop was to bring together companies, patient representatives and HTA, payer and regulatory agencies to discuss current perspectives and opportunities for Facilitated Regulatory Pathways (FRPs) [...]
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 [...]