Growth & emerging markets metrics (GEMM) programme

The globalisation of pharmaceutical markets has increased the demand for high-quality information on the development and registration of new medicines in growth and emerging markets. CIRS’ GEMM Programme helps companies navigate these fast-evolving markets by providing comparative regulatory data and insights.

The Programme collects company data annually on:

  • Product characteristics
  • Regulatory processes and market dynamics
  • Submission and approval timelines
  • Factors influencing patient access to medicines.

This data is anonymised, aggregated and analysed, providing an industry-wide view of the regulatory landscape across 20 key jurisdictions in Asia, Latin America, the Middle East and Africa. Participating companies can benchmark their performance against industry trends.

Annual Deliverables

  • Core Report – A comprehensive 150+ page report with industry-wide and company-specific analyses, aimed at Global Regulatory Leads, Strategy, and Intelligence
  • Executive Summary Report – A concise overview of key outcomes, aimed at Management and Policy/Advocacy
  • Country Summary Report – Country-specific regulatory snapshots with high-level insights, aimed at Regional Affiliates
  • Online Analysis Tool – An interactive, secure platform for benchmarking and analysing programme data, updated annually based on participant feedback
  • Industry Discussion Meeting – A forum for discussing trends, regulatory developments, and new analyses based on the most recent data collection
  • Company-Specific Analyses* – Bespoke analyses tailored to participants’ reporting needs
  • Insight Seminars* – Custom sessions providing updates on CIRS’ activities and discussions on topics of mutual interest related to the Programme

(*Upon request and subject to availability.)

Frequently asked questions (FAQs)

The CIRS GEMM Programme collects company data annually on: 

  • Product characteristics 
  • Regulatory processes and market dynamics 
  • Submission and approval timelines 
  • Factors influencing patient access to medicines. 

This data is anonymised, aggregated and analysed, providing an industry-wide view of the regulatory landscape across 20 key jurisdictions in Asia, Latin America, the Middle East and Africa. Participating companies can benchmark their performance against industry trends. 

The CIRS GEMM Programme covers the following jursidictions: 

 

  • Latin America – Argentina, Brazil, Colombia, Mexico 
  • Middle East, Africa, Russia & Turkey – Algeria, Egypt, Israel, Russia*, Saudi Arabia, South Africa, Turkey, United Arab Emirates 
  • Asia – China, Chinese Taipei, India, Indonesia, Malaysia, Singapore, South Korea, Vietnam 

 

* With consideration to submissions made to Russia via the Eurasian Economic Union (EAEU). 

The GEMM database contains regulatory submission and approval data provided annually by participating companies, covering 20 markets in Latin America, the Middle East, Africa, Russia, Turkey and Asia. Insights can be generated on various data captured in the database, including:  

  • General application details, e.g., assessment route, review status, Certificate of Pharmaceutical Product (CPP) and assessment report utilisation, priority review, and orphan designation 
  • Country-specific application processes, e.g., China Investigational New Drug (IND) submission and approval dates 
  • Application milestones 
  • Factors influencing patients’ access to medicines, such as company strategy, and reason(s) for delays launching a product