Published 03 Aug,2020 via bizbahrain - Recent initiatives in Gulf countries to facilitate patient access to new medicines and the advantages of integrating regulations related to drug trials and registration region wide were discussed at the GCC Regulatory Affairs Pharma Summit 2020, hosted in Dubai with the support of the UAE Ministry of Health and Prevention (MOHAP).
The annual summit, now in its fifth year, was hosted online in view of the global alert against COVID-19, with representatives from the pharmaceuticals industry and healthcare administrations analyzing key drivers of regulatory reforms in the region.
The importance of data and quality management in expediting drug registration and ensuring a safer community was also emphasized by the speakers, especially in the context of the COVID-19 crisis, which called for faster responses in terms of drug trials, approvals and import.
The UAE experience in leveraging its competitive logistics network and ongoing transition into a digital economy to ensure adequate supplies of health essentials across the region was also shared by experts during the two-day summit, held 22-23 July 2020.
His Excellency Dr Amin Hussain Al Amiri, Undersecretary of Public Health Policy & Licensing Sector in the UAE Ministry of Health and Prevention, said in his keynote address: “The well-monitored and well-controlled pharmaceutical production, strong regulatory system and superior logistics in the UAE have supported patients, economies and societies globally, especially during the ongoing efforts to contain the COVID-19 threat. As of July 19, the MOHAP has approved the export of 450 shipments of varied healthcare and hygiene essentials, including COVID-19 diagnostic kits, ventilators, PPE kits, IV solutions, sanitizers and related raw materials worth over AED 243 million to mainly GCC States, Europe, Australia and the US, in addition to countries in the Middle East, as requested by global pharmaceutical firms operating in the country and free zones across the seven emirates.”
Al Amiri added that all processes related to medical products, including manufacturing, registration and export, have been accelerated and intensified in the UAE as part of ensuring business continuity. MOHAP has so far seen 518 new pharmaceutical products registered, 636 renewed and 759 random samples taken from warehouses and pharmacies tested in its laboratory during this pandemic alert period.
The pharmaceuticals market in the UAE is expected to be worth AED 19.1 billion by 2024, Al Amiri said citing a report by Fitch. His Excellency also referred to the ongoing clinical research on COVID-19 vaccines in the UAE, which is in its Phase III and expected to support efforts to achieve self-sufficiency in medicines and medical products. The UAE Law No. 8 of 2019 on Medical Products, Pharmacy Profession, and Pharmaceutical Establishments has established a modern legal framework under which medical and health-related consumer goods are placed in the local market. The law encompasses processes and requirements related to clinical trials, product registration, licensing, pricing, post-market surveillance and safety reporting, among others.
Best practices and innovations in drug registration, import as well as exports and distribution in the UAE, Oman, Bahrain, Kuwait and Saudi Arabia were presented at the summit. Regulatory requirements related to ensuring quality and safer communities in the region were also discussed in relation to the GxP assurance and validation guidelines that cover manufacturing, control, storage and distribution of pharmaceuticals.
“Knowledge-sharing within the pharmaceuticals fraternity that includes manufacturers, distributors and regulators have become more critical than ever with the world facing a pandemic of unprecedented proportions. GCC countries have shown a robust response to the crisis and the UAE has led from the front, enhancing drug production and expediting clinical trial of vaccines. Stronger GCC-level co-ordination and integration in pharma regulation will be beneficial to the local, regional and international patient community,” Said Dr. Najiba Al Shezawy, Director General of PRA Consultancy which organizes the summit.
Mona Al Moussli, Managing Director at PRA Consultancy added that the summit has continued to play a major role in aligning the fast growth in GCC healthcare with global trends and enhancing local competencies in countries within the region. “Research has repeatedly indicated an exponential growth in GCC healthcare and pharmaceuticals sector, mainly driven by economic growth, ageing populations and lifestyle-related diseases. COVID-19 has also reminded the region about the importance of innovative solutions and preparedness, which can also be turned into an opportunity with improved co-ordination on practices and policies.”
Protection of intellectual property (IP) rights in the pharmaceutical sector and understanding REMS (Regulation, Evaluation and Mitigation Strategies) were also discussed at the summit. Participants had roundtable sessions with healthcare authorities from the UAE, Oman, Saudi Arabia, Kuwait and Bahrain on their respective drug regulatory dynamics.
Professionals Regulatory Affairs (PRA) is a consultancy firm based in Dubai that advices and helps companies register pharmaceutical, medical devices, cosmetics, personal care, supplements, veterinary, herbal products & toys with authorities in the GCC region. The firm also offers other services like eCTD file preparation, translation of artwork from English to Arabic and vice versa complying with the regional labeling guidelines. It has an impressive foothold in Middle East that benefits companies in finding their distributors through us. With its extensive expertise, strong network and reliable connections, the firm can also assist in doing the credibility check of distributors and market access of products in the region.
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