The National Health Regulatory Authority (NHRA) has enhanced its service for managing changes to registered medicines, aiming to improve the customer experience when updating and amending medicine data, in line with regulatory standards and requirements for the registration of pharmaceutical products.
Under the enhanced service, the time required to complete the process has been reduced and the level of review procedures has been strengthened to ensure the safety and quality of implementation, while improving the efficiency of the regulatory system overseeing medicine.
This has been achieved through the development of the service for changes to registered medicines (major/minor), enabling the approval of amendments to previously licensed products following a review of documentation and supporting data related to the product’s quality, safety and efficacy.
The development also included reducing the service completion time from 45 days to 40 working days for major changes and seven working days for minor changes.
Applications are submitted electronically, with documents attached and fees paid, followed by review and approval issuance through the ‘Adweya’ system.
Improvements also included reducing service levels and the number of required approvals, and unifying service information across all channels, enhancing efficiency and transparency.
NHRA chief executive officer Dr Ahmed Al Ansari said that the development reflects the authority’s direction towards advancing institutional performance by leveraging modern technologies to support the efficiency of pharmaceutical oversight and enhance the reliability of procedures in line with the best regulatory practices in the health sector.
“The development reflects the NHRA’s keenness to improve its services in a way that reduces time and effort for pharmaceutical companies, contributes to enhancing procedural efficiency, and supports the safe and efficient circulation of pharmaceutical products in compliance with approved regulatory requirements,” he added.
As part of ongoing government efforts to develop and re-engineer government services, more than 1,300 government services have been documented, translated and published, with around 800 services undergoing development and re-engineering across various government sectors.
&uuid=(email))