The Africa Centers for Disease Control and Prevention (Africa CDC) has provided its support for Egypt to establish a regional biomanufacturing hub for North Africa.

非洲疾病控制和预防中心（非洲疾病预防控制中心）为埃及建立北非区域生物制造中心提供了支持。

Ayman Ashour, Egyptian Minister of Higher Education and Scientific Research

埃及高等教育和科学研究部长艾曼·阿苏尔

The selection reflects Cairo’s commitment to advancing pharmaceutical manufacturing, particularly vaccine production, and strengthening biotechnology research, according to Ayman Ashour, the Egyptian minister of higher education and scientific research, adding that the achievement aligns with Egypt’s strategy to enhance health security both domestically and across Africa, aiming for vaccine self-sufficiency..

埃及高等教育和科学研究部长艾曼·阿苏尔（AymanAshour）表示，这一选择反映了开罗致力于推进制药生产，特别是疫苗生产，并加强生物技术研究，并补充说，这一成就符合埃及加强国内和整个非洲健康安全的战略，旨在实现疫苗自给自足。。

The selection of Egypt as the headquarters for the Regional Center for Capacity Building in Biomanufacturing (RCCN), in partnership with Morocco, follows the approval of Egypt’s proposal, submitted by the Unified Procurement Authority (UPA) under the Egyptian Vaccine Manufacturers Alliance (EVMA).

在埃及疫苗制造商联盟（EVMA）下的统一采购局（UPA）提交的埃及提案获得批准后，埃及与摩洛哥合作，选择埃及作为生物制造能力建设区域中心（RCCN）的总部。

EVMA comprises the Unified Procurement Authority (UPA), the Academy of Scientific Research and Technology, the Egyptian Drug Authority, the Faculty of Pharmacy–Ain Shams University, the Faculty of Pharmacy–Cairo University, alongside vaccine manufacturers, including VACSERA, Biogeneric Pharma, Egyptian Vaccine City, GenVax, and Eva Pharma..

EVMA包括统一采购局（UPA）、科学研究与技术学院、埃及药品管理局、艾因·沙姆斯大学药学院、开罗大学药学院，以及疫苗制造商，包括VACSERA、Biogeneric Pharma、埃及疫苗城、GenVax和Eva Pharma。。

ML3 designation

ML3名称

This initiative is viewed as a significant step toward positioning Egypt as a biomanufacturing leader in Africa, reinforcing regional health security and vaccine production capabilities, the statement concluded.

声明总结称，这一举措被视为朝着将埃及定位为非洲生物制造业领导者、加强地区卫生安全和疫苗生产能力迈出的重要一步。

The Egyptian Drug Authority (EDA) recently earned the WHO’s Maturity Level 3 (ML3) designation for medicines regulation, marking Egypt as the first African nation to achieve this status for both medicines and vaccine regulation.

埃及药品管理局（EDA）最近获得了世卫组织药品监管成熟度3级（ML3）的称号，标志着埃及成为第一个在药品和疫苗监管方面取得这一地位的非洲国家。

Jean Kaseya, MD, director general, Africa CDC.

Jean Kaseya，医学博士，非洲疾病预防控制中心总干事。

“Egypt’s accomplishment is a source of immense pride, not only for the country but for the entire continent,” said Jean Kaseya, MD, director general of Africa CDC. “It marks a significant step forward in advancing the African Union’s Agenda 2063 and promoting health equity. This achievement underscores the transformative power of investing in robust regulatory systems, which are critical for ensuring access to quality, safe, and effective medical products.”.

非洲疾病预防控制中心（Africa CDC）总干事Jean Kaseya医学博士表示：“埃及的成就不仅是国家的骄傲，也是整个非洲大陆的骄傲。”。“这标志着在推进非洲联盟2063议程和促进卫生公平方面迈出了重要的一步。这一成就突显了投资于健全监管体系的变革力量，这对于确保获得优质、安全和有效的医疗产品至关重要。”。

However, Africa CDC also emphasizes that Africa remains the only continent without a regulatory authority that has achieved WHO Maturity Level 4 (ML4)—the highest standard in regulatory excellence. This gap underscores the urgent need to enhance Africa’s capacity to independently ensure the safety, efficacy, and quality of high-risk medical products, noted Kaseya.

然而，非洲疾病预防控制中心还强调，非洲仍然是唯一一个没有监管机构的大陆，该监管机构已达到世卫组织成熟度4级（ML4），这是监管卓越的最高标准。Kaseya指出，这一差距突出表明迫切需要加强非洲独立确保高风险医疗产品的安全性、有效性和质量的能力。

“Closing this gap is critical for bolstering the continent’s health security and resilience,” he added..

他补充道：“缩小这一差距对于加强非洲大陆的健康安全和恢复能力至关重要。”。。

Egypt’s pharmaceutical industry reportedly produces over 90% of its medicines domestically and exports to more than 100 countries. This achievement highlights the crucial role of local manufacturing in building resilient and self-reliant health systems.

据报道，埃及制药行业90%以上的药品在国内生产，并出口到100多个国家。这一成就突显了当地制造业在建立有弹性和自力更生的卫生系统中的关键作用。

News

新闻

Biomanufacturing

生物制造

Biomedical research

生物医学研究

Biotechnology products

生物技术产品

Regulatory policies

监管政策