Around The Globe
The Current Middle East Regulatory Environment and Near-Term Future Developments – An Industry Perspective
Greg Jordinson
Associate Director,
Janssen Research & Development UK
Nadine Otin
LEEM, France
Sylvie Meillerais
Director Global Regulatory Policy, MSD Europe
he Middle Eastern regulatory environment continues to evolve as regulatory advancements are made around the world. An important issue regulatory agencies in the Middle East are currently focusing on is broad and timely access to innovative medicines, and how this increased access contributes to the world-wide improvement of quality of life and life expectancy.
Effective, enlightened regulation leads to improvements in healthcare outcomes by speeding access to medicines as well as by enhancing economic competitiveness. Bearing these points in mind, there have been significant and transformational changes in regulatory legislation, accelerating access to innovative medicines in several important countries, for example the introduction of accelerated review pathways (such as Verification and Abridged review processes) in Saudi Arabia, Jordan, and Egypt. Undoubtedly, there are more changes to come as other countries reflect on the changes around them and adopt their own versions of improved regulation.
The biannual DIA Middle East Regulatory Conference (MERC) provides a unique platform for continuous dialogue on regulatory developments in the Middle East. The last meeting was held in Kuwait in November 2017 and gathered over 240 attendees discussing country-level progress and challenges, as well as opportunities for increased regional collaboration. Regulators, industry representatives, and other experts will re-convene in the Middle East in 2019.
From an industry perspective, changes in regulation should occur across the entire product lifecycle, as innovation encompasses the continuous supply of these medicines, reflecting advances in manufacturing and quality standards. Health authorities are anticipated to evaluate introducing such accelerated review pathways to optimise their resourcing with regard to lifecycle management.
Online submission pathways simplifying the submission process and improving transparency during review are being advocated, most notably by the Saudi Food and Drug Authority (SFDA) and the Gulf Health Council. Online submissions bring a number of benefits, and we expect more authorities to introduce these in the next few years.
Serialisation, trace, and track are areas where regional health authorities are leading the way, bringing the benefits of cost control and stock management, and providing more effective anti-counterfeiting measures to patients in the region.
Regarding pharmacovigilance, a survey conducted by the Kuwait Food and Drug Control (KDFC) showed a great need for training and educating healthcare providers (HCPs) in the Gulf Region in order to ensure ongoing and robust monitoring of medicines. Further focus on pharmacovigilance, including adverse event awareness and data collection, is expected and encouraged.
Industry welcomes these changes, and would appreciate further opportunities to discuss new legislation developments. However, it is important that these discussions are open and transparent for all to continue to build the trust and confidence of all stakeholders in these discussions (including payers, the public, and patients). Industry is grateful for the “open-to-discussion” approach regarding new regulations, and we anticipate (and hope) that the regional health authorities will continue to engage with industry when developing new regulations. Openness and continuous dialogue are key to reaching common ground among all parties. We believe that these changes are for the benefit of all, but most importantly for the benefit of patients.
Regulators in the Middle East will continue to develop their legislation and push for increased compliance. In this context, the benefits of regulatory convergence and harmonisation should be evaluated while recognising that such concepts may not always be applicable in all scenarios.