GCC Pharma Summit Brings Focus On Efficient Drug Safety And Approval Protocols

Healthcare regulators in the Gulf region and pharmaceutical industry professionals came together to discuss the increasing importance of expediting approval of new drugs and vaccines in the aftermath of COVID-19, as well as competitive pharmaceutical regulations at the 7^th GCC Regulatory Affairs Pharma Summit, held 21-22 March 2022 in Dubai.

The annual summit, which is the region’s foremost platform for local and international pharmaceutical and medical industry professionals to engage with healthcare administrators across GCC, plays a vital role in expediting drug registration and approvals, thereby improving patient access to healthcare.

Along with familiarizing professionals on the current priorities in pharmaceutical regulations across GCC, the Summit also focused on mergers and acquisitions in the in the pharmaceutical sector, in addition to the importance of pharmacovigilance. Pharmacovigilance involves the detection, assessment, understanding and prevention of adverse effects of medicines and vaccines.

Addressing the delegates at the Summit, His Excellency Dr Amin Hussain Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing Sector in the UAE Ministry of Health and Prevention, said: “If I will go to recognize our ecosystem and how it has been supported in the UAE and the Pharma Market Value, and how the pharma companies are being supported in the market; we are able to reach the highest healthcare market value by 2022 which is 81.4 and it is expected to reach 139.9 billion in 2030 billion UAE Dirhams. In addition, the UAE Pharmaceutical market has reached a percentage of 14.4 and is expected to increase to 23.8 billion in 2030.”

H.E Dr. Al Amiri also spoke about the advancing pharmaceutical innovation, by stating that there are 175 new molecular entities registered in the past three years and that this number is the highest number thus far of registered NMEs in MEA.

When H.E spoke about the local manufacturing activities, he stated in his presentation that there are 1800+ Locally manufactured products and 156 innovative medicines produced locally.

The first day of the Summit heard healthcare authorities in the UAE, Oman, and Bahrain providing updates on the pharma regulations in place in their respective domains, and later joining senior executives from leading regional and international pharmaceuticals companies for a round table discussion.

The industry professionals on their part highlighted the most important drug-related issues to be considered by GCC regulatory authorities, such as Value-based Pricing, Lifecycle Management, Combination Products, Biosimilars & Interchangeable Biologics, Value-added Medicine, and Regulatory Timelines.Senior executives representing the health authorities in Jordan, Tunisia, and Ethiopia briefed the delegates at the Summit on the practices and procedures they have adopted for fast and efficient registration and approval of drugs.

“Knowledge and alignment with international practices and standards in healthcare are relevant more than ever today. Consistent focus on maintaining high standards and adopting best international practices played the major role in GCC healthcare coming up with a robust response to COVID-19,” Dr. Najiba Al Shezawy, Managing Director at PRA Consultancy, the organizer of the summit, said referring to the importance of the GCC Regulatory Affairs Pharma Summit,

Procuring vaccines early on and launching extensive vaccination campaigns were instrumental in GCC countries leading in reopening to the world post the pandemic. The UAE led internationally in vaccination and became the first in the Arab world to begin manufacturing of a COVID-19 vaccine.The pandemic is predicted to spur drug manufacturing across the GCC.

“The GCC Pharma Affairs Regulatory Summit has evolved into a premier forum for knowledge exchange within the region’s healthcare.,” added Dr Shezawy.

“A dynamic and progressive regulatory framework that makes patient safety the topmost priority is critical for GCC given the healthcare targets and projected demand for pharmaceuticals across the region. The GCC Regulatory Affairs Pharma Summit is conceived as a forum to sustain stakeholder collaboration in drug registration and approvals, and thereby improved patient access to healthcare,” said Dr Mona Al Moussli, Managing Director at PRA Consultancy.

A report by Fitch Solutions, pharmaceutical spending in GCC is set to reach $25.7billion by 2028 as urbanization, ageing population and chronic lifestyle-related diseases boost demand.

The GCC Regulatory Affairs Pharma Summit also honored the of the GCC Pharma Regulatory Award 2022. Training sessions, intended to provide professionals from the healthcare and pharmaceuticals industries with an understanding of the drug safety protocols in place in various countries in the region, were also held parallelly during the Summit.