Regulatory framework takes centre stage on day 2 of Int’l Conference on Pharmaceuticals 

AMMAN — Day two of the Jordan Food and Drug Administration’s (JFDA) Third International Conference on Pharmaceuticals — the Royal Vision for Achieving Drug Security, shed light on harmonising the regulatory framework of the pharmaceutical industry.

Speaking during the first session, Abdelnaser Sijari, president of the board of directors of the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, highlighted the significance of industrial cooperation and integration among Arab countries. 

Sijari said cooperation and integration could be achieved through harmonised registration criteria and mutual recognition among health institutions, the establishment of an integrated Arab pharmaceutical market, the development of the pharmaceutical industry in the region and the adoption of technological innovations in drug development.

Regarding the regulatory affairs surrounding the development of pharmaceuticals, he noted the need for the harmonisation in laws relating to the sector that would accelerate the submissions and approvals of pharmaceutical products.

Sijari added that “the Arab region is home to over 650 pharmaceutical companies. Yet the region’s pharmaceutical sector, together with African pharmaceutical companies, account for only 2.96 of the global pharmaceutical market”. 

Almost half of the region’s pharmaceutical production is consumed in Saudi Arabia and the United Arab Emirates, he noted.

“The approval cycle across the MENA region takes between 12 to 36 months which is a long period,” said Safaa Abu Gharbia, senior director of regulatory affairs at Hikma. 

Abu Gharbia added that the sector’s regulatory system requires “an encouraging landscape”.

To overcome barriers facing the industry, she said that the current registration processes are affecting the availability and continuity of pharmaceutical products. Therefore the harmonisation of regulatory requirements among Arab countries together with their alignment with international standards, and the creation of a hub for site accreditation for all Arab countries, would bring about new possibilities and development to the industry, she explained.

According to Secretary General of the Jordanian Association of Pharmaceutical Manufacturers Hanan Sboul, Jordan is home to 27 pharmaceutical factories. The local pharmaceutical exports stand at around JD450 million.

Other sessions discussed the importance of enabling biologicals and biosimilars to promote the sector across the region, the need to have a continuous evolution in the pharmaceutical industry, and the strategic importance of medical tourism.