Roadmap for Regulatory Performance
Every regulatory authority in the world has an ambition to improve its performance. In order to achieve this, agencies often establish performance indicators which they use for measuring and [...]
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 [...]
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, [...]
CIRS RD Briefing 78 – HTA outcomes in Australia, Canada and Europe 2015-2019
This Briefing presents data from HTADock, an ongoing metrics study that collects data on new active substances (NASs) appraised by eight HTA agencies and analyses synchronisation between the regulatory [...]
Regulatory observations across Latin America
As numerous factors have recently contributed to changes in the regulatory environment, we have been monitoring and analysing structural regulatory issues affecting overall access to medicines in the Latin [...]
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 [...]
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 [...]
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 [...]
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 [...]
Patel et al 2020 – Analysis of regulatory review timelines for ANVISA
Background: The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and [...]