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Hong Kong Drug Registration

Hong Kong offers one of the most strategic entry points for pharmaceutical manufacturers targeting Asia. Under the “one country, two systems” framework, Hong Kong operates its own pharmaceutical approval process, independent from China, while the Greater Bay Area (GBA) Connect Scheme opens access to a market of about 80 million.

Cisema guides you through every step of the Hong Kong pharmaceutical registration process so you can secure approval with confidence and accelerate regional expansion.

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A high-angle cityscape of Hong Kong featuring densely clustered skyscrapers against a bright sky with layered clouds. The turquoise harbor stretches into the distance, dotted with small vessels and bordered by mountainous terrain. The scene reflects a major hub for regulatory compliance activities, product registration workflows, and China market access consulting services, highlighting the region’s strategic role in supporting businesses entering China and the broader Asia-Pacific market.

What Organizations Are Responsible for Hong Kong Drug Registration Approvals?

Pharmaceutical products in Hong Kong must be registered under the Pharmacy and Poisons Regulations before they can be sold or distributed. The Hong Kong Drug Office and the Pharmacy and Poisons Board jointly oversee this process, ensuring that all pharmaceutical products entering the market meet the required standards of safety, quality, and compliance.

The Hong Kong Drug Office

The Drug Office acts as the enforcement agency overseeing the legislation related to medicines. It evaluates the safety, efficacy, and quality of pharmaceutical product registration applications, assesses applications for clinical trials, and conducts risk assessments for Adverse Drug Reaction (ADR) reports.

The Pharmacy and Poisons Board

The Pharmacy and Poisons Board is the authoritative body responsible for the actual registration of pharmaceutical products. It ensures that all medicines meet the necessary legal and regulatory standards before they can be sold, offered for sale, distributed, or held for sale or distribution in Hong Kong.

What is the Greater Bay Area (GBA) Connect Scheme?

The Greater Bay Area (GBA) Connect Scheme, introduced on November 6, 2019, allows urgently needed drugs, medical devices, and IVDs — with no comparable product approved in China — to be sold to designated hospitals across the GBA’s two SARs (Hong Kong and Macao) and nine Pearl River Delta municipalities in Guangdong Province.

Covering a population of about 80 million, including major cities such as Shenzhen, Zhuhai, and Guangzhou, the scheme offers manufacturers a faster route into the China market. With 45 participating Hong Kong–owned healthcare institutions as of September 2024, the scheme enables companies to leverage Hong Kong’s independent regulatory system within a region positioned as a global innovation hub.

 

How Can Cisema Support?

Cisema supports you from Hong Kong pharmaceutical registration approval through to Guangdong MPA pre-submission for GBA Connect Scheme access. We manage the drug registration process with the Hong Kong Drug Office, ensuring clear, efficient communication across time zones and languages.

  • Providing legal representation in Hong Kong as the registration applicant and certificate holder, including pharmacovigilance responsibilities
  • Reducing application errors through extensive regulatory experience and a strong client network.
  • Ensuring smooth project execution with dedicated technical expertise.
  • Strengthening your submissions through long-standing relationships with Hong Kong authorities within the framework of our Code of Conduct
  • Preventing delays by bridging language and cultural differences
  • Keeping you ahead of regulatory changes through continuous updates
A group of five Cisema team members in the Hong Kong office stand and sit around desks with laptops and monitors, collaborating in a bright workspace with large windows overlooking city buildings. The modern office setting reflects professional support for pharmaceutical regulatory compliance, product registration processes, and market-access consulting for companies entering China.

List of GBA Scheme Hospitals

First Batch (5 Hospitals)

  1. University of Hong Kong-Shenzhen Hospital
  2. Modern Hospital Guangzhou
  3. Guangzhou United Family Hospital
  4. C-MER (Zhuhai) Dennis Lam Eye Hospital
  5. Zhongshan Chenxinghai Hospital

Second Batch (15 Hospitals)

  1. The First Affiliated Hospital, Sun Yat-sen University
  2. Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  3. Nanfang Hospital of Southern Medical University
  4. Guangdong Provincial People’s Hospital
  5. Guangzhou First People’s Hospital (Nansha branch)
  6. Clifford Hospital
  7. C-MER (Guangzhou) Dennis Lam Eye Hospital
  8. Shenzhen Qianhai Shekou Free Trade Zone Hospital
  9. Shenzhen Hyzen Hospital
  10. C-MER (Shenzhen) Dennis Lam Eye Hospital
  11. The First Affiliated Hospital of Guangzhou Medical University Hengqin Hospital (former Zhuhai Hengqin Hospital)
  12. Foshan Fosun Chancheng Hospital
  13. Dongguan Songshan Lake Tungwah Hospital
  14. Dongguan Guangming Ophthalmic Hospital

Third Batch (25 Hospitals)

  1. The First Affiliated (Nansha) Hospital of Sun Yat-sen University
  2. The Third Affiliated Hospital of Sun Yat-sen University
  3. The Sixth Affiliated Hospital of Sun Yat-sen University
  4. Zhongshan Eye Center of Sun Yat-sen University
  5. Sun Yat-sen Cancer Center
  6. The First Affiliated Hospital of Jinan University
  7. Guangdong Maternal and Child Health Hospital
  8. Guangdong Provincial Hospital of Traditional Chinese Medicine
  9. The First Affiliated Hospital of Guangzhou Medical University
  10. Guangzhou Women and Children’s Medical Center
  11. Qianhai Life Insurance Guangzhou General Hospital
  12. Southern Medical University Shenzhen Hospital
  13. Shenzhen Luohu District People’s Hospital
  14. Shenzhen Bao’an Maternity and Child Healthcare Hospital
  15. Shenzhen New Frontier United Family Hospital
  16. Shenzhen Hengsheng Hospital
  17. Peking University Shenzhen Hospital
  18. The Fifth Affiliated Hospital of Sun Yat-sen University
  19. C-MER (Foshan) Eye Hospital
  20. Huizhou Third People’s Hospital
  21. C-MER (Huizhou) Eye Hospital
  22. Donghua Hospital (Dongguan)
  23. Zhongshan People’s Hospital
  24. Jiangmen Central Hospital
  25. Chia Tai Guojian Kangfu Hospital (Zhaoqing)
  26. Guangzhou First People’s Hospital (updated listing)

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