Developing strong product dossiers for quality-assured medical products and ensuring swift and effective review are critical factors that help increase access to quality-assured medicines for millions of patients in low- and middle-income countries.
Electronic common technical document (eCTD)
Improving access to safe and effective medicines starts with manufacturing quality-assured products. But medicines don’t go to market, or into the hands of patients, without manufacturers submitting product dossiers for regulatory review. The electronic common technical document (eCTD) is the global standard for dossier management that improves on previous paper-based systems to simplify processes, shorten reviews, and reduce logistical challenges. eCTD helps manufacturers and regulators prepare, submit, and review important medical product information more quickly, effectively, and sustainably.
Read the eCTD guidance
Electronic quality management systems (eQMS)
Increasing the supply of quality-assured medicines relies on pharmaceutical manufacturers that comply with good manufacturing practices (GMP) and develop effective quality management systems (QMS). Yet, most manufacturers in low- and middle-income countries use paper-based QMS, which is less efficient than electronic QMS and subject to human error, increasing the risk of non-compliance. eQMS helps manufacturers streamline production and ensure they meet consistent quality standards.
Read the eQMS guidance
