International – 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)…