Asian Patient Access Program (APAP)
Simplifying Access to Innovative Medicines
for Asia’s Self-Paying Patients
APAP is a groundbreaking initiative designed to bridge the gap in medical access for patients across Asia.
- Provides immediate access to advanced medications tailored for self-paying patients in Asia.
- Eliminates the need for local registration processes, simplifying approvals.
- Addresses the critical medical needs of 173 million rare disease patients across 48 Asian countries.
- Delivers a seamless and efficient process with measurable outcomes.
The program offers three tailored solutions to meet the diverse needs of Asian patients and originators:
APAP offers a flexible gateway to Asian markets, delivering immediate results while complementing Macau’s registration pathway to maximize opportunities and ensure sustainable growth.
New York-Based Asian Patient Access Program
Asian Local Patient Access Program (Macau & Singapore)
Macau Fast-Track Registration Program
New York-Based Asian Patient Access Program
Objective:
- Leverage ACA Pharma’s U.S. wholesale accounts to deliver treatments directly to self-paying patients in Asia, bypassing local registration processes.
Key Features:
- Originators authorize new drugs to be added to ACA Pharma’s U.S. wholesale accounts (e.g., ICS, ASD Healthcare, AmerisourceBergen), ensuring smooth and efficient access.
- Medications are delivered through temporary import permits issued by local governments for hospitals or individual patients, addressing urgent patient needs.
- Backed by ACA Pharma’s 30+ years of experience and an extensive network of specialty healthcare providers across Asia.
- Eliminates the need for local registrations, reducing regulatory barriers and mitigating geopolitical risks.
- Ensures rapid market entry, providing patients timely access to advanced and life-saving treatments.
Asian Local Patient Access Program (Macau & Singapore)
Objective:
- Establish local patient access programs after fast-track registration in Macau and Singapore.
Key Features:
- Expedited registration processes are exempt from clinical trials.
- Programs designed for self-paying patients across Asia, using U.S. retail or European market pricing.
- Provides open channels for timely treatment while addressing regional policy sensitivities.
Macau Fast-Track Registration Program
Objective:
- Rapidly access major markets like the Guangdong Greater Bay Area, Beijing, and Shanghai with a streamlined 30-90 day registration process.
Key Features:
- Facilitates real-world data collection to support national approvals.
- Provides a foundation for broader access through the Asian Patient Access Program.
Why Choose ACA Pharma?
- 30+ Years of Expertise: Extensive experience in Asia’s pharmaceutical industry.
- Established Network: Collaborations with leading doctors, hospitals, and distributors.
- Proven Success: 54 drugs registered, 7 more in progress, benefiting millions of patients.
- Flexible Solutions: Tailored programs that adapt to Originators’ needs.
Dual-Path Strategy: Immediate Results and Long-Term Growth
Drawing on ACA Pharma’s deep understanding of the growing demand for innovative therapies post-launch, our Strategic Dual-Path Approach provides originators with tailored options to meet their strategic goals:
- Immediate and Low-Risk Entry: Fast, efficient, and hassle-free
APAP enables originators to enter Asian markets rapidly, bypassing local registration and reducing complexity for immediate impact. - Long-Term Market Expansion: Building sustainable growth with strategic foresight
Macau’s registration pathway supports broader access, including hospitals, pharmacies, and national insurance systems, paving the way for lasting success. - Flexible and Adaptable Strategy: Customized solutions for dynamic market needs
Dual pathways provide originators with flexibility to address diverse market challenges and maximize opportunities.