Hong Kong Pharmaceutical Registration and Approval

The Pharmacy and Poisons Board (PPB) requires all pharmaceutical products in Hong Kong to
be registered prior to being marketed in Hong Kong, according to the Pharmacy and Poisons
Ordinance (PPO).

During the drug registration process, the PPB evaluates the safety, effectiveness, and quality of
the drug by analyzing scientific data. To register a new chemical or biological entity in Hong
Kong, the applicant must provide proof of registration approval for the product from at least 2 of
the 32 specified countries, which include the United States, Australia, Austria, Belgium,
Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Holland, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Poland,
Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, and the UK.
Recently, mainland China was included in the list of countries recognized by the PPB because
China started implementing the ICH guidelines. In addition, Korea, Brazil, and Singapore have
recently been added to this list too. However, these four countries are not designated as a
Stringent Regulatory Authority (SRA) by the WHO. Hence, in addition to registration from 1 of
these four countries, registration from 1 of the 32 countries listed above must also be provided
for drug product registration in Hong Kong.

The entity responsible for applying for drug registration in Hong Kong depends on the origin of
the product. If the product is made in Hong Kong, the manufacturer should apply for registration.
On the other hand, if the product is produced outside Hong Kong, the local importer is
responsible for obtaining registration.

To register your pharmaceutical product in Hong Kong, you need to use the Pharmaceuticals
Registration System 2.0 (PRS 2.0) online, which can be accessed through the website of the
Drug Office of the Department of Health. The essential documents necessary for the registration
of a pharmaceutical product in Hong Kong consist of several items, such as a copy of the
business registration certificate, free sale certificate from the country of origin, a cover letter, the
manufacturer's license, the manufacturer’s authorization letter, GMP certificate, etc.
In addition to the basic documents required for registration of a pharmaceutical product, there
are also several essential documents that need to be submitted. These include documents
demonstrating conformity with the reference pharmacopoeia, certificate of analysis, stability test
data, etc.

To learn more about how PBM can help you register your drug products in Hong Kong, please
contact us.