E-DRUG: USP - New Resource for Risk-Based Post-Marketing Surveillance
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Dear e-drug,
The negative health and economic impacts of substandard and falsified medicines worldwide are well documented. USP is pleased to share a new document, Risk-based post-marketing surveillance of medicines: Implementation resources for low- and middle-income countries.
<https://www.usp.org/global-public-health>
Post-marketing surveillance (PMS) is a key regulatory function that helps medicines regulators maintain the safety, efficacy and quality of the products that reach the public. Implementing an effective PMS program can be challenging given the competing priorities of regulatory agencies as well as limitations in human and financial resources. RB-PMS is an approach that allows countries to apply their limited resources toward products and locations with the highest risks to their populations.
This document collects and describes several USP resources for RB-PMS implementation. USP developed the resources during its sustained support to strengthening quality-assurance systems in LMICs and to help regulators promptly detect and remove poor-quality products from the market. Several resources were developed with support from the U.S. Agency from International Development.
The document is available in English and Spanish. All of the resources can be accessed and downloaded for free from the USP website.
Please share widely with your networks.
Megan Meline
Sr. Communications Manager
Promoting the Quality of Medicines Plus Program
U.S. Pharmacopeial Convention
12601 Twinbrook Parkway, Rockville, MD, 20852, USA
Megan Meline <megan.meline@USP.org>