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Patients at the Heart of Middle East Drug Regulation

he DIA 13th Middle East Regulatory Conference (MERC) in Cairo, Egypt, opened with the touching and impactful testimony of a patient from Jordan and continued to bring the patient to the heart of two days of scientific exchange, constructive dialogue, and compelling debate about the challenges and opportunities throughout the Middle East.

Key Takeaways

  • Regulatory dynamics vary across the region’s various nations: While some countries are working to simplify processes and others to implement digital systems, many are working to implement fast-track approval systems that will accelerate access to medicines for patients in the region.
  • As gene therapies and other innovative treatments begin to reach the Middle East, regulatory science in the region must develop further and faster.
  • Regulators and health agencies must reflect on the proper balance between price and value, as defined by patient outcomes, that will deliver a trusted, sustainable environment for all biological medicines, including biosimilars.

Patients are Waiting: WHO, Health Authority, and Industry Approaches to Accelerate Patient Access to Innovation

The first session after the patient’s keynote was driven by the notion that patients are waiting for innovative medicines and that regulators should be encouraged to use regulatory reliance pathways and other accelerators to help deliver them. Perspectives from ICH and WHO were complemented by challenges and opportunities presented by the Central Administration of Pharmaceutical Affairs (CAPA) of the Egyptian Drug authority, the Jordan FDA, and the Saudi FDA, concluding with suggestions for further propagating best regulatory practices to other health authorities in the region.

Regional Regulatory Dynamics: Today and Tomorrow

Middle East health authorities shared aspects of their rapid evolution over the past several years, their current dynamics, and their vision and goals for the future. In general, these authorities are proactively looking into adapting novel regulatory approaches and other reforms.

  • The Gulf Health Council announced several new initiatives, including the fast-track registration process (upon the condition of registering the product in two reference member states), online submissions, and a fully electronic system for use among Gulf countries.
  • Bahrain is focusing on implementing digital systems for invoicing and products clearance, including full implementation of a track and trace system by September 2021.
  • Host country Egypt is also exploring fast-track implementation to accelerate access to medicines, as well as process simplification that does not sacrifice safety or quality.
  • Jordan became an ICH observer in 2019 and continues to work through an important transition period to ensure successful implementation of new guidance in the future.
  • Kuwait is successfully implementing fast-track and other agency-level lifecycle management enhancements.
  • Oman looks to build capacity in pharmacovigilance and to establish its own independent drug regulatory authority while harmonizing with neighbouring countries in the Gulf region.
  • The Saudi FDA, the region’s most advanced health authority, shared its experience of meeting monthly with industry to improve transparency in their communication, and introduced pre-submission meetings for this same purpose; announced the availability of a new pricing guideline expected in the first quarter of 2020; and shared the Saudi government’s vision for the next decade (2030).

Transforming Fundamental Research into Innovative Treatments

Innovation in the pharmaceutical sector takes many forms and has brought significant benefits to patients. Listening to the voice of patients and patient advocacy groups further stimulates such innovation. As these innovations change the science of healthcare, regulatory science must correspondingly change to ensure that these innovations continue to meet patient needs. As novel technologies targeted towards individual patients, including cell and gene therapies, are coming to market globally, data used to obtain marketing authorisations for such products are often limited, with their full benefit risk profile yet to be described and novel data (such as real world evidence) and data collection methodologies not yet fully accepted by many regulatory authorities. With gene therapies already approved in some Middle East markets, the regional regulatory environment must develop further and faster in response.

Current and Future Trends for HTA

Signifying a shift in mentality toward a more deliberative model, health technology assessment (HTA) has become one of the most important topics across the region, as governments aspire to modernize healthcare systems and adopt measures for evaluating healthcare interventions. With developing economies struggling with rising healthcare costs and limited resources, clarity of purpose on the role of HTA and how it fits into existing institutions’ processes are critical, especially in the planning stages. Middle East countries recognize valuable lessons learned from countries that have already implemented HTA as they start building their own foundations. This also presents opportunity for “newly aspiring HTA countries” to address emerging methodological and practical concerns raised by modern technology. Discussions clearly recommended that multi-stakeholder dialogue is critical.

Convergence and Reliance for Post-Approval Changes: Where do we stand today?

Although most countries have now adopted EU or WHO guidelines on post-approval changes to not only manufacturing but to marketing authorizations in general (in line with recommendations put forward in 2017), this adoption remains partial and not complete. For example, the concept of post-approval reliance outlined by WHO is still not reflected in most local guidelines. Nevertheless, this conference illustrated several different levels of implementation across the market, including notable progress made by the Saudi FDA, implementing set timeline for each of the Variations category, and the WHO highlighting potential workshops to address the specific adoption needs of each country.

In addition, industry representatives introduced the EFPIA Safety Label Update position paper, which stressed the importance of aligning approval cycles to support the timely availability of materials which are shared across the region. Other discussions opened dialogue on novel regulatory tools such as post-approval change management protocols, and on ICH Q12 (adopted in November 2019), which is especially important as several countries in the region are now embarking on the ICH journey as observers.

Roadmap for eCTD

Discussions about the region’s challenges and opportunities concerning implementation of eCTD provided the opportunity for experts to describe how implementation of this technology could be optimized: After reviewing the eCTD experience in EU, representatives from the Oman and Kuwait health authorities shared their experience from implementing the eCTD for the past three to four years, as did agencies with more recent implementation, such as the Jordan FDA.

Use of Biosimilars in the Middle East: Vice or Virtue?

All panellists agreed in these discussions that the promise of biosimilars to lower costs and increase access is genuine. However, international experience has shown that it is essential to build a robust regulatory framework, as outlined by WHO guidelines, to unlock this potential in a sustainable way. Experience also demonstrates that questions about quality, interchangeability, substitution, immunogenicity, and pharmacovigilance (among others) remain. Regulators and health agencies must reflect on the proper balance between price and value, as defined by patient outcomes, that will deliver a trusted, sustainable environment for all biological medicines, including biosimilars. The patient’s best therapeutic interest must be at the centre of this and other debates about biosimilars, and education and dialogue about biosimilars throughout the regional healthcare ecosystem remain crucial.

Digital Transformation in Regulatory Affairs

Regulatory affairs functions are no exception to the technological changes impacting today’s medicines lifecycle. Digital transformation of regulatory affairs holds great potential for improving the function and driving continuous and improved value of these organisations. The concepts of eLabelling and structured submissions led to discussion of how to realize these innovative approaches in the Middle East.

Pharmacovigilance in the MENA Region

The first DIA pharmacovigilance workshop in the Middle East and North Africa (MENA) Region, presented in parallel with MERC, focused on efforts to simplify and harmonize pharmacovigilance guidelines and announced release of the Algerian Good Pharmacovigilance Practice GVP (revised version) which came into place in October 2019. It also highlighted the importance of raising the understanding that pharmacovigilance is needed in every aspect of healthcare product development, regulation, and patient use.

In conclusion, the 13th edition of MERC was an excellent opportunity to discuss the key topics for the development of the region. A special thank you is due to Conference Chair Professor Peter Pitts, to all Programme Committee members and to all Stakeholders that shared their learnings and contributed to the fruitful discussions.

Global Forum thanks all contributors to this report:

Inas Chehimi
MERC Chair & Head RA Middle East & North Africa
Novartis Pharma Services AG, United Arab Emirates

Sara Torgal

Catherine Al Ashram
MSD, Jordan

Dina Fathy
MSD Gulf, United Arab Emirates

Fadilla Lakkis
GSK, Lebanon

Greg Jordinson
Janssen R&D, United Kingdom

Nadine Otin
LEEM, France

Paul Dearden
Biogen, UK

Peter Pitts
MERC 2019 Chair
Center for Medicine in the Public Interest, US

Rachelle Ross
Biogen, UK

Susanne Ausborn
Hoffmann-La Roche Ltd, Switzerland

Sylvie Meillerais
MSD (Europe) Inc., Belgium

Virginia Acha