Steps taken to streamline regulatory processes in the Middle East

When the DIA’s Middle East Regulatory Conference convened in Kuwait late last year, an array of hot topics drew considerable discussion. The gathering, which brings together multiple stakeholders from multinational companies, local manufacturers and agents/distributors with representatives of health authorities from across the region, focused on verification/reliance procedures, lifecycle management, harmonization initiatives, pharmacovigilance, barcoding, serialization and biosimilars.

Three key trends in the region caught our attention in particular.

First, we’re seeing more and more support around relying on approvals in regions or countries with stringent regulatory authorities (such as the European Medicines Agency or the U.S. Food and Drug Administration [FDA]) for fast track approval in the Middle East. This is an important initiative undertaken by leading health authorities in the region including the Saudi Food and Drug Authority, the Jordanian Food and Drug Administration and the Egyptian Drug Authority. By relying on U.S. or EU approvals, these authorities are granting faster market access especially for innovative medications which help the patients in the region to have access to the latest drugs and technologies. These local authorities are now targeting 30 and 60 working days to grant marketing authorization approvals versus at least a full-year review timeline in the past. This is particularly important in the case of drugs that treat serious conditions and fill an unmet medical need.

In this same perspective of getting faster access of drugs to patients in need, there is a new initiative from the Gulf Health Council to implement a new electronic system for centralized registration across the Gulf. An upgraded electronic platform has been announced where the eCTD dossier will be shared with all Gulf member states for review and an increased number of review meetings will be in place. This initiative will allow faster centralized registration and a robust mechanism that can help companies in getting registration possible in all Gulf member states within shortened timelines. The council is targeting a one-year approval timeline; local pricing will be the only step to occur at the national level.

There is eagerness from both the industry and the regulator sides to see this level of harmonization and the implementation of fast-track procedures after so many years of heavily bureaucratic review processes in the Middle East delaying market access and requiring a lot of effort and resources from manufacturers.

Another hot topic discussed in detail during this conference was the track and trace initiative in the region. Several key advances are taking place:

  • 2D GS1 barcoding is already a mandatory requirement to be mentioned on the outer box for Saudi Arabia. Serialization was fully implemented in March 2017 there. The country is acknowledged as a leader worldwide in requesting a full track and trace system with a serial number for each box.
  • Egypt is expected to enforce serialization by June 2018.
  • Jordan will require 2D GS1 barcoding by June 2018.
  • Purchasing bodies in the United Arab Emirates (UAE) began asking for 2D GS1 barcoding beginning in January 2017.

These examples of regional authorities implementing efficient traceability measures should contribute to better supply chain management, increased product quality assurance and reduction of counterfeit products in the region.

Finally, cycle management also was a focus at the meeting. New guidelines from the UAE, Jordan and Kuwait were presented. Although different in their content, all guidelines were customized according to local market needs, industry feedback and actual resources at the level of each health authority:

  • Kuwait: Pre-approval is now required for all variation types. Notification process is not available anymore. Donia al Bastaki of the Kuwait Ministry of Health, Drug and Food Control (KDFC) said at the conference that the issuance of approval letters for all variation types (pre-approval) minimizes the delays in shipment release/clearance because in the past companies were not submitting all variations especially those for chemistry, manufacturing and controls. It is now possible to bundle several variations when they are interrelated (such as change of manufacturing site affecting finished product specifications [FPS], stability data, etc.).
  • UAE: Pre-approval is not needed for the new variation types except for Type IB which is great news for the industry that wants to implement ongoing changes as soon as possible. Even for the types requiring re-pricing, the company can implement the change within the stated timeline and the price letter will follow separately.
  • Jordan: A guideline was adopted in September 2017 and it now is being implemented on a pilot scale. As a major update, there was a change in the classification of several variations in favor of reducing the pre-approval requirements or technical committee assessment. Several variations require notification now versus Regulatory Approval (RA) before. Several variations classified as requiring Technical Committee Approval (TCA) have now been shifted to the RA category. This new guideline also includes new variation types covering changes in active pharmaceutical ingredients (APIs) and biologicals changes.

Editor’s Note: Makram Nehme, a regulatory affairs expert for the Middle East and Africa, contributed to this report.

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