This Briefing provides an overview of how advisory committees can be used to support the regulatory decision-making process and considering the context of Latin American regulatory systems, aims to [...]
Background: Despite the growing application of facilitated regulatory pathways (FRPs), little attention has focused on assessing the perception of pharmaceutical companies regarding their usefulness beyond increasing timeliness. Objectives: The [...]
Purpose: The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate [...]
Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order [...]
This workshop was part of a series of workshops on reliance, which continues to be an important area of focus for CIRS. It builds on the outcomes of a [...]
This workshop was a follow-on from a collaborative forum held in Utrecht in 2018 entitled What new research can enable a joint approach by regulatory and HTA agencies to [...]
Background: The Caribbean Regulatory System is a centralized medicine assessment procedure established to serve the needs of the Member States of the CARICOM region. In order to better understand [...]
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, [...]
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 [...]
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 [...]
