Frequently Asked Questions

Your Essential Guide to Understanding and Defining Pharma Solutions

Registration

What is the timeframe for drug registration in Macao?

The registration process for new and orphan drugs in Macao typically takes between 30 to 90 days, ensuring a swift market entry.

What documents are required for drug registration in Macao?

We require manufacturing authorization, Certificate of Analysis (COA), a sample bottle, and FDA-registered CTD documents to complete the registration process rapidly.

Can ACA Pharma register drugs without additional clinical trials?

Yes, our process does not require additional clinical trials, allowing for quicker market access.

Distribution

Where can registered drugs be distributed?

Once registered, drugs can be distributed across major hospitals in the Guangdong Great Bay Area, Hainan, and Tianjin, covering over 120 million people.

How does ACA Pharma ensure compliance in distribution?

ACA Pharma is fully licensed and compliant with regulatory standards in Macao and New York, holding wholesale drug licenses, retail pharmacy licenses, and DEA licenses.

Partnerships

How does ACA Pharma support partnerships?

We establish strong partnerships with US and EU manufacturers, ensuring seamless market entry and distribution of medications.

What is the Contract Sales Organization (CSO) model?

In the CSO model, ACA Pharma handles the commercialization of registration and sales without a mileage fee, particularly beneficial for older drugs with short patents.

Pricing

What costs are involved in the registration process?

Our business model requires no additional investment from the manufacturer. We handle all registration, distribution, and logistics aspects.

How is pricing handled in different regions?

In Macao and Hong Kong, products are covered by local government insurance post-registration. In the Guangdong Great Bay Area, sales proceed on a self-pay basis, and post-national registration, products can be included in national medical insurance.
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