About ACA Pharma
Frequently Asked
Questions
ACA Pharma helps innovative medicines and devices reach patients faster—starting with Macau and Hong Kong fast-track pathways, then bridging into Mainland China and other key markets through compliant, end-to-end commercialization.
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Registration
What is the timeframe for drug registration in Macau?
For eligible products, Macau can be one of the fastest drug registration pathways in Asia. Once ACA Pharma has received the full set of required documents and is able to submit a complete application, approval is often achievable in approximately 30 to 90 days. This makes Macau not only an efficient route for initial market entry, but also a strategic bridge into select Mainland China pilot zones and broader regional access opportunities that may follow.
What is the timeframe for medical device registration in Hong Kong?
For eligible medical devices, Hong Kong can be one of the fastest and most practical entry pathways in the region. Once ACA Pharma has received the full set of required documents and is able to submit a complete application, the Hong Kong device listing process is typically achievable in about three months. This makes Hong Kong an efficient route for initial market entry and a strategic bridge into select Mainland China pilot zones, such as the Greater Bay Area, where Hong Kong-based device pathways can help support broader access opportunities that may follow.
What documents are required for drug registration in Macau?
Macau’s registration pathway is designed to be relatively streamlined, with a focused checklist that is typically under 10 core items for a standard submission. In most cases, the key documents include a Letter of Authorization, a Certificate of Pharmaceutical Product (CPP), and electronic copies of essential supporting certificates such as GMP. The technical submission generally includes CTD Modules 2 through 5, together with a Risk Management Plan and a Certificate of Analysis (COA). Sample requirements are also straightforward, as only one sample box is typically needed, containing the product itself and the instruction leaflet.
Can ACA Pharma register drugs without additional clinical trials?
Generally, yes. ACA Pharma’s preferred market-entry pathways—such as Macau, Hong Kong, and Singapore—typically rely on products that already hold approval in recognized reference markets such as the FDA, MHRA, or EMA, which means additional local clinical trials are often not required for initial registration. This allows companies to pursue faster first registrations using existing approval packages and supporting data. From there, for Mainland China, ACA Pharma can also help support strategies that leverage real-world evidence generated through pilot zones, which may contribute to potential accelerated pathways toward broader national approval.
Distribution
Where can registered drugs be distributed?
Once approved in Macau, eligible medicines can serve as a practical bridge into select Mainland China access pathways, particularly within the Greater Bay Area, a region of approximately 120 million people. The Greater Bay Area framework allows 71 designated hospitals in Mainland GBA cities to use certain urgently needed Hong Kong-registered drugs and eligible devices. Separately, Hainan’s Boao Lecheng pilot zone provides another important route for urgently needed imported drugs and devices under its own approval process, rather than requiring Macau registration first. Depending on the product and clinical need, ACA Pharma can also support access through top specialist departments in major Tier 1 cities and, for pediatric orphan therapies, through our network of 44 leading pediatric hospitals nationwide.
How does ACA Pharma ensure compliance in distribution?
ACA Pharma supports compliant distribution through a structured operating model that combines our own affiliates in key markets with market-specific procedures aligned to applicable regulatory and quality requirements. Depending on the jurisdiction and product, this includes controlled documentation flows, importation and release coordination, labeling and traceability oversight, pharmacovigilance and quality process support, and clear responsibility allocation across the supply chain. Where needed, we also coordinate with qualified local service providers and healthcare institutions to help ensure products are handled, supplied, and monitored in accordance with local laws and established standards.
What is the GBA "Medicine & Equipment Connect" channel?
Launched in 2021 under a November 2020 work plan, the scheme lets designated Grade-A hospitals across the nine mainland Guangdong cities of the Greater Bay Area import and use drugs already registered in Hong Kong — or routed via Macau’s fast-track pathway — for patients meeting an “urgent clinical need” test, without prior National Medical Products Administration (NMPA) market authorization. The Guangdong authority decides each hospital’s batch-import license within roughly 20 working days, after which treatment can begin.
The channel is designed for products not yet approved on the mainland, and real-world evidence generated at the pilot sites can later support a national registration filing. The network of designated institutions and approved products has expanded steadily since launch.
Partnerships
How does ACA Pharma support partnerships?
ACA Pharma partners with innovative originators in the U.S. and Europe to deliver fast, compliant, and asset-light market entry across our target markets. We support the process end to end—from registration strategy and market entry through distribution and in-market execution—while funding the path from origination to commercialization ourselves. For partners, this creates a streamlined model with no need to build local infrastructure upfront, as ACA Pharma typically earns its return through a negotiated supply price once sales begin. This model is particularly beneficial for older drugs with short patents and orphan drugs with limited patient populations, as it ensures efficient market entry and maximizes commercial potential.
What are originators responsible for in the relationship?
ACA Pharma aims to keep the process as low-lift as possible for the originator’s team. In most cases, the originator’s primary responsibilities are to provide the core documents and technical materials needed for registration, support review of promotional or medical materials where required, and make appropriate regulatory or medical affairs personnel available for occasional training or product-related questions. Beyond that, the originator can remain focused mainly on manufacturing and supply, while ACA Pharma manages the local execution required to bring the product to market.
Pricing
What costs are involved in the registration process?
Under ACA Pharma’s partnership model, the originator typically does not bear upfront registration or market-entry costs. ACA Pharma generally funds the process end to end, including registration, distribution setup, marketing support, warehousing, and, where needed, practical local execution items such as relabeling or restickering. For the originator, the model is designed to be low-lift and asset-light: rather than funding local infrastructure or launch activities, the key commercial requirement is to agree on a supply price that gives ACA Pharma sufficient margin to support these activities, while the originator remains focused on providing reliable product supply.
How is pricing handled in different regions?
Pricing is evaluated on a product-by-product and market-by-market basis, as there is no single standard approach across all regions. ACA Pharma typically discusses the target market price with the originator as part of the commercial planning process, taking into account the product profile, competitive landscape, patient-access environment, and local market dynamics. From there, the parties negotiate a supply price that allows ACA Pharma to support the required registration, distribution, commercialization, and other in-market execution activities with a sustainable margin. Where relevant, ex-Europe pricing may serve as a helpful reference point, but final pricing strategy is always tailored to the specific product and region.
Does selling through the GBA Connect or Macau Fast-Track channel put US pricing at risk under MFN?
No. The US MFN framework benchmarks US prices against a defined set of reference markets, and mainland China, Hong Kong, and Macau fall outside that set. Under the US Department of Health and Human Services (HHS) guidance issued in May 2025, the MFN target price is the lowest price in an OECD member country with a GDP per capita of at least 60% of the US figure. The narrower CMS GENEROUS model uses an even smaller basket — the second-lowest net price among eight countries (the UK, France, Germany, Italy, Canada, Japan, Switzerland, and Denmark), adjusted for GDP per capita.
China, Hong Kong, and Macau are not OECD members and do not appear in any version of the reference basket. As a result, a price recorded in the GBA urgent-import channel cannot mathematically enter a US MFN calculation. Manufacturers who have signed product-specific pricing agreements directly with the US administration should review those contract terms separately, since the operative basket for them is whatever the agreement defines; but the publicly announced definitions all exclude China.
Are prices in the GBA urgent-import channel publicly visible the way NRDL prices are?
No. Sales through the Hong Kong–Macao Medicine and Equipment Connect pathway run on confidential, hospital-level supply contracts. Each designated hospital applies to the Guangdong Medical Products Administration for its own batch import authorization, and because these products are not on China’s national reimbursement lists, patients pay out-of-pocket. There is no centrally published, negotiated price of the kind generated by the National Reimbursement Drug List (NRDL) process.
This distinction matters for external reference pricing generally. A confidential contract price is far harder for any foreign payer to discover and cite than a published national tariff — so even in markets that do reference one another’s prices, the GBA channel offers limited price transparency to outside observers.