Jordan Advances Regulatory Framework for Biotech Drugs at Scientific Conference

Amman, May 19 (Petra) — The Jordan Food and Drug Administration (JFDA) hosted a scientific conference on Sunday to discuss regulatory mechanisms for registering biotechnological pharmaceutical products, with a focus on biosimilars and their growing role in modern healthcare.

Opening the conference, JFDA Director General Nizar Mhaidat highlighted the agency’s commitment to facilitating investment in biosimilars and biotech drugs, and to promoting local manufacturing in line with international standards. He noted that expanding access to these treatments, which are widely used and costly, would help reduce healthcare costs while improving patient care.

Mhaidat praised Jordan’s pharmaceutical sector for its technological capabilities, citing the recent launch of Arwan-Jordan’s facility to produce the raw material “Erythropoietin alpha” as a significant step in localizing high-value drug production. He also welcomed the strong Arab participation in the conference, describing it as a clear indication of regional momentum toward pharmaceutical integration.

In his remarks, Chairman of Arwan Pharmaceuticals, Eng. Abdul Razzak Yousef, said the company, originally based in Lebanon and now registered in more than 17 countries, had successfully registered its first biotech drug. He confirmed plans to begin transferring the manufacturing technology for “Erythropoietin alpha” to Jordan through the new facility. Yousef emphasized that the JFDA’s adoption of Good Manufacturing Practices (GMP) and global biotech standards had enabled this development.

The conference featured technical sessions on various aspects of biotech drug regulation. Dr. Ahlam Abdulaziz, head of the JFDA’s Biologics and Vaccines Department, presented on the authority’s requirements for registering biosimilars. Prof. Bashar Al-Khalidi of the University of Jordan addressed the criteria for accrediting manufacturing sites involved in the production of biologics.

Additional sessions explored the clinical requirements for biosimilars containing “Erythropoietin alpha,” presented by clinical research consultant Dr. Rana Bustami. Dr. Antoine Barbari discussed the therapeutic use of the same compound in treating chronic kidney disease.

The conference concluded with a panel discussion on the future of biosimilars, moderated by Dr. Rana Malkawi, Director of the JFDA’s Drug Directorate.

Attendees included Jordanian and international nephrologists, academic experts, pharmacists, and representatives from medical unions and professional associations.

//Petra// RZ
19/05/2025 12:39:53