05/07/2025
🔹 Industry News - Africa and Middle East 🔹
1️⃣ Digital Regulatory Upgrade in South Africa:
South African Health Products Regulatory Authority (SAHPRA) launched its Engagement Portal, enabling online submissions, real time communication, and streamlined reviewing of product applications—including registrations, renewals, and export requests.
2️⃣ EMA–Africa Collaboration Boosts Regulatory Capacity:
The European Medicines Agency (EMA) held a landmark joint meeting with the African Medicines Agency (AMA) board. This marks a major step towards regulatory harmonization, knowledge sharing, and faster access to approved medicines across African markets.
3️⃣ African Regulatory Agencies Formalize Cooperation:
Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Zimbabwe, and other Level 3 NRAs signed an MoU to share assessments, inspections, and streamline medicine/vaccine approvals—supporting the African Medicines Regulatory Harmonization agenda.
4️⃣ Nigeria Launches Continental Pricing & Reimbursement Network:
Supported by the EU-funded MAV+ project, eleven African countries launched the African Information Network on Pricing and Reimbursement in Dakar to improve transparency and cost-efficient access to essential medicines.
5️⃣ Saudi Arabia’s Pharma Sector Set to Lead:
Saudi Arabia’s pharmaceutical market is projected to reach 36.5 billion SAR, driven by aging demographics and chronic disease prevalence. Local manufacturers like Astra Industrial and JamJoom are emerging as key regional players.
6️⃣ Middle East Pharma Market Sees Strong Growth:
The broader Middle East & Africa pharma market, valued at $30 billion in 2024, is expected to grow to $42+ billion by 2030 (CAGR ~6.1%), fueled by population growth, rising healthcare investment, and expansion in generics.
7️⃣ Counterfeit Drug Crackdown in Lebanon:
Lebanon has launched a major investigation and arrests following a scandal involving counterfeit cancer medications (durvalumab), triggering national reforms to secure the drug supply chain and restore public trust.
🔍 What This Means:
🔹 Stronger Digital Processes: SAHPRA’s portal marks a shift toward faster, more transparent regulatory systems in Africa.
🔹 Continental Collaboration: EMA–AMA and MoU initiatives indicate growing regulatory unity and shared resource efficiency.
🔹 Rising Market Value: As demand grows, Gulf countries are emerging as key regional pharmaceutical hubs.
🔹 Compliance & Trust: Lebanon’s counterfeit incident underscores the need for strict vigilance and solid regulation.
