Around the Globe

The Regulatory Reliance Review Model:
Adoption in the Middle East
Inas Chehimi
Head, Regulatory Affairs Middle East & North Africa
Novartis Pharma Services AG

he years 2017-2018 were transformational in the regulatory dynamics of the Middle East region, specifically reforms targeting the review process for innovative molecules. We have witnessed issuance of new regulations adopting the Reliance Review Model in several countries in the Middle East.

The principle of the Reliance Review Model (RRM) is in line with the WHO recommendations to optimize resource use and avoid duplication of effort; in general, the recommendations are to conduct marketing application reviews on the basis of Assessment Reports, Good Manufacturing Practice (GMP) inspections reports, and/or Certificates of Pharmaceutical Products (CPPs) of the reference authorities.

Saudi FDA First to Adopt RRM

The first country to announce adoption of the RRM in the Middle East was the Kingdom of Saudi Arabia, represented by the Saudi FDA (SFDA), the local regulatory Agency responsible for issuing Marketing Authorization Approval. SFDA published this announcement in October 2016, and followed it with detailed guidance in February 2017.

The Reliance Model adopted by SFDA includes mention of two reference Health Authorities, the US FDA and Europe’s EMA. In the guidance, SFDA identified two types of procedures:

  • Verification procedure: 30-day review process of marketing applications predicated on approvals issued by EMA and FDA.
  • Abridged procedure: 60-day review procedure predicated on approvals issued either by EMA or FDA.
  • In both procedures, the un-redacted assessment report issued by the reference Health Authority (EMA or FDA) is mandatory to be submitted for review.

We have been observing the implementation of this model in Saudi Arabia for the last seven calendar quarters, and have noticed that the average review timeline in both procedures (Verification or Abridged) was six to seven months. This represents a significant improvement in review timelines compared to the previous procedures before the implementation of the RRM (the average timeline was previously estimated to be 16 to 18 months). Yet, the aspirational goal of 30/60 days review procedures is not yet achieved.

Over the last seven calendar quarters, SFDA has demonstrated openness to dialogue with the pharmaceutical companies around areas of improvement in the implementation process. Several face to face meetings between pharmaceutical company representatives and the SFDA to consider and discuss proposals to overcome hurdles currently observed during the review process will definitely pay off for the benefit of Saudi patients.

Adoption by Other Health Authorities

The reliance model dynamic that was kicked off in the Middle East by SFDA was adopted later by other Health Authorities in the region: Jordan, Egypt, and UAE (United Arab Emirates).

  • Considered among the early adopters of this model immediately after Saudi Arabia, in February 2017 the Jordan FDA published in their official Journal a brief note about the verification procedure (60-day review process), followed by a detailed final guideline published in July 2017.
  • In January 2017, the Egypt Ministry of Health issued Ministerial Decree 820/2016 announcing the adoption of the 30/60 days review procedures; however, the implementation date of this procedure was officially announced in April 2018 after the detailed guideline was issued.
  • The United Arab Emirates (UAE) Ministry of Health issued its Ministerial Decree in January 2018 with immediate implementation, and published its detailed guideline in February 2018.

Future columns will provide more details and insights about Jordan, Egypt and UAE procedures.