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Regulatory Focus™ > News Articles > 2019 > 11 > WHO Seeks to Expand Access to Insulin With Prequalification Program

WHO Seeks to Expand Access to Insulin With Prequalification Program

Posted 13 November 2019 | By Zachary Brennan 

WHO Seeks to Expand Access to Insulin With Prequalification Program

As only about half of the 65 million people worldwide with Type 2 diabetes who need insulin can access it, the World Health Organization (WHO) on Wednesday announced the creation of the first prequalification program for insulin manufacturers.

The pilot prequalification program seeks to expand the pool of quality insulin products via an evaluation to ensure their quality, safety and efficacy.

WHO said the program is limited to insulin products either approved by a stringent regulatory authority and marketed in that country, which will be offered an abridged assessment by WHO, or insulin products registered by a non-stringent authority but which will be assessed by WHO under its full assessment pathway.

Following an expression of interest, WHO will undertake a quality assessment to determine whether the product is manufactured in compliance with current good manufacturing practices (cGMP).

WHO said the program is necessary because current insulin prices and availability pose a barrier to treatment in most low- and middle-income countries. Insulin has been on WHO’s Essential Medicines List since the list was first published in 1977.

In the US, meanwhile, insulin prices have spiked in recent years, which has led to rationing and deaths. Congressional bills have been proposed to lower the price of insulin, but none have passed.

In addition, in March 2020, FDA will begin transitioning certain biological products, such as insulin, initially approved under new drug applications (NDAs) to biologics that can be used as reference products for biosimilar or interchangeable insulin products. The transition could mean there will be a prolonged period when there will not be any regulatory action or development of new or follow-on insulin products.


1st Invitation to Manufacturers of human insulin to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Team - Biotherapeutic Products (BTPs)

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