WHO workshop on implementation of Guidelines for procedures and data requirements for changes to approved vaccines

Overview

Regulation of changes to approved vaccines is one of the most important elements in ensuring that the vaccines of consistent quality, are distributed after they receive authorization or licensure. In response to the request from National Regulatory Authorities (NRAs) of the World Health Organization (WHO) Member States on the data needed to support changes to approved vaccines to ensure the comparability with respect to quality, safety and efficacy of vaccines manufactured with the change, WHO have developed Guidelines for procedures and data requirements for changes to approved vaccines.

To facilitate the implementation of these guidelines, a three-day workshop was organized by the WHO Headquarters with great assistance from EMRO and CO in Oman, in Muscat, Oman from 8-10 November 2022 for the countries from EMR and AFR where were identified there is a need for improving the regulation of post-approval changes. The workshop was convened in the hotel of Grand Millennium Muscat. The event was organized with help of the local regulatory authority of Oman, Directorate General of Pharmaceutical Affairs & Drug Control, Ministry of Health. This workshop was participated by the representatives of national regulatory authorities from Bahrain, Egypt, Islamic Republic of Iran, Jordan, Lebanon, Oman, Pakistan, Saudi Arabia, Sudan, Syria Arabia Republic, Tunisia, and United Arab Emirates