At ACA Pharma, we specialize in fast-track registration and tailored market entry solutions for Asia. Our services include streamlined registration in Macau, Hong Kong, and Singapore for new and innovative drugs, enabling rapid access to the Asian market. Through initiatives like the Asian Patient Access Program (APAP), we provide flexible solutions to meet urgent patient needs and empower originators to swiftly expand sales to unregistered regions worldwide, complementing Macau’s registration pathway and ensuring long-term success through our extensive physician network

• 82 New Drugs Registered
• Quick Registration in Macau (30-90 Days)
• 100% Registration Success Rate
• No Additional Clinical Trials Required
• Zero Additional Investment Needed

Fast-Track China Access Pathways

We have built a proven network that enables rare disease therapies to reach patients in China rapidly — without requiring national registration or clinical trials.

Macau 30–90 Day Registration

• Rapid approval in Macau, enabling immediate supply to:
• 45 hospitals in the Greater Bay Area serving 120M+ people
• Pediatric orphan drug access to 44 top pediatric hospitals, covering 95% of pediatric rare disease patients
• No national registration or clinical trials required
• Hong Kong and Singapore (14M people) with government reimbursement coverage

Direct Group NPP Procurement (Immediate Market Access)

• 44 top pediatric hospitals and leading medical centers, covering 95%+ of pediatric rare disease patients
• Hospitals apply directly for long-term national import permits, bypassing registration
• Initiated through a simplified Purchase & Confidentiality Agreement
• Proven model: first validated with Deflazacort (DMD drug), now available nationwide

Accelerated National Registration – RWE Pathway

• For pediatric orphan drugs: national registration achievable in 3–6 months
• For clinically urgent and other orphan drugs: national registration achievable within approximately 12 months
• Enabled by real-world data collection in the Greater Bay Area, providing credible clinical evidence for regulatory submission

Critical Care Solutions

• Our Critical Care Solutions enable rapid access to pediatric and clinically urgent medications; support fast-track national approvals and ensure broad media coverage for patient awareness. These services streamline access to life-saving treatments while facilitating market entry for innovative drugs. Learn more about our services.