To make access to quality-assured insulin and diagnostic devices a top priority, barriers to regulatory pathways must be identified and addressed. ACCISS has commisioned reports that look at the challenges that biosimilar insulin companies face in seeking marketing authorisation, as well as an overview of the regulatory landscape for glucose self-monitoring tools.
REGULATORY PROFILE: GLUCOSE SELF-MONITORING TOOLS | Profile
The report aims to identify some of the challenges and opportunities that arise due to the current
state of regulation of these self monitoring tools. An emphasis is placed on identifying measures to help
secure equitable access to quality devices for people living with diabetes, regardless of the location
of their use.
BIOSIMILAR INSULIN REGULATORY PROFILE | Report | Fact Sheet
The Biosimilar Insulin Regulatory Profile discusses the regulatory pathways and challenges faced by companies seeking marketing authorisation for insulin biosimilars, particularly in highly-regulated markets such as the European Union (EU) and the United States (US). It also includes a case study of two manufacturers who sought marketing authorisation from the European Medicines Agency (EMA) for insulin products.