Hong Kong Drug Registration

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Hong Kong Registration of Drugs

Under the “one country, two systems” framework, Hong Kong has its own separate marketing approval process for pharmaceutical products as compared with China mainland. Pharmaceutical products in Hong Kong must be registered under the Pharmacy and Poisons Regulations. This registration is mandatory before any pharmaceutical product can be legally sold, offered for sale, distributed, or held for the purpose of sale or distribution in Hong Kong.

WHAT ORGANIZATIONS ARE RESPONSIBLE FOR HONG KONG DRUG REGISTRATION APPROVALS?

The Hong Kong Drug Office and the Pharmacy and Poisons Board of Hong Kong work closely together to regulate pharmaceutical products. 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 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. Together, these two entities ensure the safety and quality of pharmaceuticals in the Hong Kong market.

GREATER BAY AREA (GBA) CONNECT SCHEME

Since November 6, 2019, registration of drugs in Hong Kong has become much more attractive to overseas medical device manufacturers because manufacturers may seek to take advantage of the Greater Bay Area “connect scheme”. This scheme permits products (medical devices, IVDs or drugs) that are urgently needed for clinical use and with no other similar product already for sale in China to be sold into certain hospitals within the southern China Greater Bay Area including Shenzhen, Guangdong, Zhuhai and a number of other large cities. The GBA region has a population size of around 80 million people.

As of January 2024, there are 19 Hong Kong-owned healthcare institutions participating in the connect scheme:

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

The Greater Bay Area consists of two SARs (Hong Kong and Macao) and nine Pearl River Delta municipalities in the Guangdong Province. China aims to build the Greater Bay Area into a hub of global technological innovation and an important source of emerging industries. For the past years, more and more medical institutions owned or managed by Hong Kong enterprises have been providing healthcare services in the Greater Bay Area.

Cisema can support you through the process of obtaining Hong Kong registration approval of your pharmaceutical product through to pre-submission at Guangdong MPA to prepare for accessing the GBA connect scheme.

...and what added value does Cisema create for you?

Legal representation in Hong Kong as the applicant for registration and certificate holder in regulatory affairs, carrying out responsibilities such as pharmacovigilance.
Application for drug registration with the Hong Kong drug office.
Avoid mistakes during your application process for drugs application, and benefit from our extensive years of experience and large client network.
With office locations worldwide, we are always at your disposal, mitigating effects of timezones and business hours.
Avoid unneccessary setbacks due to language barriers and cultural differences.
We maintain healthy long standing relationships with the Hong Kong authorities within the framework of our Code of Conduct.
We support you with our technical know-how and strive for seamless project progression within your timeline.
We will constantly keep you updated regarding changes to regulations, so you can stay one step ahead.

Hong Kong Drug Registration

We for you

Hong Kong Registration of Drugs

WHAT ORGANIZATIONS ARE RESPONSIBLE FOR HONG KONG DRUG REGISTRATION APPROVALS?

GREATER BAY AREA (GBA) CONNECT SCHEME

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