Dr. Ali El-Ghamrawy, chairman of the Egyptian Drug Authority (EDA), held a meeting with the leadership of the Holding Company for Biological Products and Vaccines (VACSERA), headed by Dr. Sherif El-Feel, Chairman of the Board, to follow up on the mechanisms for local manufacturing of several vital vaccines. The meeting comes within the Authority’s efforts to support the State’s strategy for localizing vaccine production and achieving self-sufficiency in strategic biological products.

The meeting reviewed the executive progress of various manufacturing stages, discussed plans to complete bioequivalence and quality studies, and reviewed the proposed timelines for raw material supply and fulfillment of registration and technical inspection requirements.

Dr. El-Ghamrawy emphasized that the EDA places the localization of vaccine manufacturing as a top priority within its strategic plan, in line with the directives of the political leadership to strengthen local production of biological and strategic products. He explained that these efforts aim to enhance international confidence in Egypt’s manufacturing capabilities and enable the country to produce world-class vaccines, thereby solidifying its position among leading nations in the field of pharmaceutical and biological industries.

He added that the Authority is committed to providing technical and regulatory support to national manufacturers to accelerate local production while ensuring the highest standards of quality and safety. He stressed that cooperation with VACSERA represents an effective model of national partnership in this vital sector.

For their part, VACSERA representatives affirmed the company’s commitment to advancing the localization of vaccine production and its dedication to strengthening collaboration with the Egyptian Drug Authority across all stages of manufacturing and registration. This, they noted, will bring about a qualitative leap in vaccine production, achieve self-sufficiency, and meet the needs of both domestic and regional markets.

VACSERA representatives also praised the pivotal role played by the Egyptian Drug Authority in supporting the national manufacturing ecosystem, affirming that the Authority is a key strategic partner in realizing the State’s vision for localizing biological vaccine production. They commended the EDA’s efforts in overcoming regulatory and technical challenges faced by manufacturers and its rapid response to national companies’ needs for technical assistance and regulatory oversight, reflecting the efficiency of Egypt’s pharmaceutical system and its ability to keep pace with global developments in this critical sector.

Participants from the Egyptian Drug Authority included:

· Dr. Amany Gawdat, Associate to the EDA Chairman and Supervisor of the Central Administration of the Chairman’s Office

· Dr. Asmaa Fouad, Head of the Central Administration of Biologicals, Innovative Products & Clinical Studies

· Dr. Amira Mahjoub, Head of the Central Administration for Inspection

From Vacsera:

· Major General Amir Gawdat, Chairman of the Board of Directors of the Sera and Vaccine Company

· Dr. Hanaa Omar, Regulatory Affairs Consultant, Holding Company for Biological Products and Vaccines

· Dr. Fairoz Mohy El-Din, Director of Registration Department

· Dr. Heba Ali, Head of Operations Sector, Holding Company

· Dr. Hoda Sami, Director of Production Control Department

· Dr. Samah Sami, Director of Quality Assurance Department

The meeting reflects the Egyptian State’s vision to strengthen national capabilities in the manufacturing of biological products and vaccines, thereby enhancing pharmaceutical and health security and positioning Egypt among the leading countries in vaccine production in the region.