How Middle Eastern Markets Are Transforming Drug Reviews And Driving Competitiveness

The UAE, Jordan, Egypt and Saudi Arabia have all recently announced or implemented new verification/abridged regulatory pathways to improve access to medicines and free up resources.

Middle East
Middle Eastern Markets Are Implementing new verification/abridged drug review pathways

Middle Eastern markets like Jordan and the United Arab Emirates appear to have become the frontrunners among non-ICH (International Council for Harmonisation) countries in introducing regulatory pathways that improve access to medicines. Through risk-stratification and relying on regulatory reviews by major agencies, Middle Eastern regulators are freeing up resources to tackle other problems, while also making their markets more attractive to investors.

The UAE, Jordan, Egypt and Saudi Arabia have all recently announced or implemented new verification/abridged regulatory pathways to

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approvals

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.

New EU Filings

 

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

More from Product Reviews

Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By 

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.