The three-day workshop on implementation of guidelines on procedures and data requirements for changes to approved vaccines, hosted by the Ministry of Health represented by the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) and organized by the World Health Organization Regional Office for The Eastern Mediterranean, commenced today (Tuesday) at the Millennium Hotel.

The opening program included a speech of Dr. Mohammed Al Rubaiee, Director General of Pharmaceutical Affairs and Drug Control where he pointed out that this three days’ workshop would discuss and facilitate the implementation of the WHO developed Guidelines for procedures and data requirements for changes to approved vaccines. The Guidelines provide guidance to NRAs and manufacturers on the essential data required to support the change, which does not negatively affect the quality, safety and efficacy of the vaccines and provide basic information to the authorities in the development of their own national guidelines and timely access to the vaccines needed for their immunization programmes.

The Director General of Pharmaceutical Affairs and Drug Control stressed the importance of the presence of safe and effective vaccines nowadays with the emergence of many viruses, and the COVID-19 pandemic, which has shown itself to be a common challenge all over the world.

Dr. Mustafa Hasheesh, Public Health Specialist delivered the remarks of WHO Office in Oman noting that ensuring the quality, safety, and efficacy of health products and improving  equitable access of health products are one of WHO mandates. Thus, the Organization has developed relevant guidelines and practices to ensure quality, safety, and efficacy of vaccines to assists national regulatory authorities of WHO member states in regulating the vaccines used in their immunization programmes.

Dr. Hasheesh added that WHO defined the regulatory functions however, granting a license is only the beginning of regulation. Post-approval changes may have a potential to impact the quality, safety, and efficacy of the product. Therefore, regulation of post-approval changes is essential to assure the quality of the product, he stated.

The WHO Specialist pointed out in the word that in response to the request of NRAs and industry, WHO developed Guidelines on data requirments and procedures for changes to approved vaccines to assist NRA to regulate post-approval changes in 2013.  

Around (60) participants attended the workshop from the National Regulatory Authorities in the EMR and Africa Regions.

The opening session of the workshop highlighted update on WHO position on post-approval changes in the context of WHO biological standardization.

WHO Guidelines for procedures and data requirements for changes to approved vaccines, and current approaches of regulation of post-approval changes were further reviewed. The first day of the workshop addressed also current practices of regulation of post approval changes to vaccines, biologicals in selected participating countries.

The workshop will discuss recommendations in WHO Guidelines for post-approval changes including the reporting procedures and data requirements for quality changes – Changes to antigens and final products, as well reporting procedures and data requirements for efficacy, safety and labelling information changes.

Furthermore, encouraging networking, work-sharing and reliance in the context of regulation of post-approval changes for participating countries will be stressed. Regulation of post-approval changes will be additionally discussed including identifying area for improvements, needs from the countries, and implementation plan.              

The workshop aims at promoting the regulatory aspects regarding the approved vaccines and the post-approval changes to ensure their safety and efficacy, implementing the guidelines on the changes to approved vaccines, and informing vaccines manufacturers with the basic data required to support the change, which does not negatively affect the quality, safety and efficacy of the vaccines.