REGULATORY POLICIES AND PROCEDURES

 

SRLA2011-0204

MCH aide Awa Allieu checks a pregnant woman’s blood pressure during an ante-natal consultation at the Kailahun primary health unit in the town of Kailahun, Kailahun district, Sierra Leone on Thursday March 17, 2011. © UNICEF/Asselin

Definition

Regulatory policies and procedures, such as those related to registration, quality control, drug authenticity verification, and importation can ensure that in-country public supply chains can consistently provide access to high-quality life-saving commodities. 

What is the problem?

That absence of or poorly planned or administered, policies and systems can potentially restrict product selection, delay shipment, or make entry prohibitive. Omission of life-saving commodities from the National Essential Medicines List can prevent their procurement, and limited quality control capacity can delay the testing and release of products into the system. Weak quality control and assurance systems along the supply chain, limited enforcement of existing policies, and limited capacity of regulatory bodies can all undermine the functionality of in-country supply chains.

Indicators to Measure Progress in Regulatory Policies and Procedures

The recommended performance indicator for assessing regulatory policies and procedures is the percentage of life-saving commodities included in the country’s National Essential Medicines List.

Additional indicators are:

– Percentage of products tested for quality

– Percentage of branded/generic products for each life-saving commodity procured in the last year that are World Health Organization prequalified or have stringent regulatory authority approval

– Percentage of life-saving commodities that have at least one brand registered in-country

– Percentage of life-saving commodities that are found in the national standard treatment guidelines

Read the full Supply Chain Performance Indicators Guidance here.