Access to affordable insulin remains a critical public health priority. Diabetes affects millions of people worldwide and ensuring access to quality-assured insulin products is essential for effective disease management. While human insulin remains the most affordable option and is included in the WHO Model List of Essential Medicines (EML), major suppliers are progressively phasing out older insulin products to prioritize manufacturing capacity for newer and more profitable treatments. This trend highlights the urgent need to expand the availability of affordable insulin options, particularly in low- and middle-income countries (LMICs).
In 2023, the WHO Prequalification of Medicines Programme launched the Human Insulin Master File (h-IMF) pilot procedure to facilitate the prequalification of human insulin products. The procedure is modelled on the well-established Active Pharmaceutical Ingredient Master File (APIMF) approach used for small-molecule medicines.
Although master file procedures are generally not applied to biological products due to their complexity, human insulin represents a special case as it is a relatively simple and well-characterized molecule. The h-IMF procedure allows the drug substance (DS) manufacturer to protect confidential know-how while ensuring that finished product applicants have sufficient information to assume full responsibility for the quality of the finished drug product (DP).
WHO is now expanding this pilot procedure to include insulin analogues
This expansion aims to facilitate the entry of additional quality-assured analogue insulin products into the market, potentially increasing competition and improving access to modern diabetes treatments in LMICs.
For IMF holders
The drug substance information (CTD Module 3.2.S) must already be approved by a WHO Listed Authority (WLA) within the context of a finished product marketing authorization and therefore WHO will rely on the WLA assessment and will not reassess Module 3.2.S.
For applicants for insulin finished products
WHO Prequalification will assess the drug product (DP) dossier according to the principles described in the WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Human Insulin, while cross-referencing the IMF.
For additional information, please see Insulin and Insulin analogues Master File (IMF)
As this expanded pilot procedure is launched, WHO Prequalification invites feedback from stakeholders on the procedure and the associated documentation.
Comments may be sent to prequalbiosimilar@who.int (cc: Mr Wondiyfraw Worku – zelekew@who.int).