Information on medicine licensing

Scott Edmunds made this Freedom of Information request to Department of Health

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Dear Department of Health,

I have a question about the administration and licensing of medicine in Hong Kong as the Food and Health asked me to contact you if I had queries about this. Enquiring about bear bile and proprietary Chinese medicines, they said that these can be sold for therapeutic purposes. You can see the query here:

For therapeutic medicines in Hong Kong, what evidence do they have to provide to be legally licensed? What is the procedures and evidence is required to get licensed, both for proprietary Chinese medicines and medicine prescribed by regular pharmacies and doctors. For example, is there any equivalent the assessments made by the NICE (the National Institute for Health and Care Excellence) in the UK, and what sort of information and criteria is required? For the seven bear bile products listed in my query to the FHB what procedures and paperwork did they have to produce to become licensed therapeutic medicines in Hong Kong?

Yours faithfully,

Scott Edmunds

Department of Health

Dear Mr Edmunds,

Thank you for your email of 23 June 2017 requesting for information about
medicine licensing.  Our reply is as follows:-

Pharmaceutical Product

According to the Pharmacy and Poisons Ordinance and Regulations (Cap.138,
Laws of Hong Kong), pharmaceutical products must satisfy the criteria of
safety, quality and efficacy for registration with the Pharmacy and
Poisons Board of Hong Kong (the Board) before they can be sold or
distributed in Hong Kong. The definition of "pharmaceutical product" is
provided below for your references:-

"Pharmaceutical product" and "medicine" mean any substance or combination
of substances -
(a) presented as having properties for treating or preventing disease in
human beings or animals; or
(b) that may be used in, or administered to, human beings or animals,
either with a view to –
     (i)  restoring, correcting or modifying physiological functions by
exerting a pharmacological, immunological or metabolic action; or
     (ii) making a medical diagnosis;

Please note that the applicants for registration of pharmaceutical
products are required to provide the following documents as stated in the
Guidance Notes on Registration of Pharmaceutical Products/Substances:
-        master formula of the product
-        product specifications
-        certificate of analysis of the product
-        method of analysis of the product
-        manufacturer’s licence
-        Good Manufacturing Practices certificate of the manufacturer
-        official evidence of registration approval (Note: Imported
products only)
-        reputable references and/or clinical studies to substantiate the
safety and efficacy of the product
-        proposed sales packs and/or sales labels
-        stability test data of the product
-        bioequivalence data (Note: For generic products of Anti-epileptic
drugs and critical dose drugs/ narrow therapeutic range drugs).

The Guidance Notes on Registration of Pharmaceutical Products/Substances
are available on the following webpage of the Drug Office (DO) of the
Department of Health (DH):

Please also note that the Pharmacy and Poisons Ordinance shall not apply
to Chinese herbal medicines or proprietary Chinese medicines as defined in
section 2 of the Chinese Medicine Ordinance (Cap.549, Laws of Hong Kong).

According to the database of registered pharmaceutical products maintained
by the DO, there is no registered pharmaceutical product containing bear
bile as active ingredient.

Proprietary Chinese Medicines

According to the Chinese Medicine Ordinance (Cap.549, Laws of Hong
Kong)(CMO)¸ all proprietary Chinese medicines (pCms) must be registered
with the Chinese Medicines Board (CMB) under the Chinese Medicine Council
of Hong Kong (the Council) before they can be imported, manufactured or
sold in Hong Kong. With reference to international regulatory practice,
the CMB requires that all pCms must meet the prescribed registration
requirements regarding their safety, quality and efficacy before it is
approved for registration. In applying for pCm registration, information
on these three aspects must be submitted as required by the CMB. In
addition to the requirements as stipulated in the CMO, the CMB requires
that the applicants for pCm registration should also comply with other
laws in Hong Kong, including the Protection of Endangered species of
Animals and Plants Ordinance (Cap. 586). “Certificate of registration of
pCm” (HKC) will be issued if the pCm has been assessed by the CMB as
meeting the registration requirements. The definition of pCm is provided
below for your references:-

"Proprietary Chinese medicine" means any proprietary product -
(a) composed solely of the following as active ingredients –
     (i)    any Chinese herbal medicines; or
     (ii)         any materials of herbal, animal or mineral origin
customarily used by the Chinese; or
     (iii) any medicines and materials referred to in subparagraphs (i)
and (ii) respectively;
(b) formulated in a finished dose form; and
(c) known or claimed to be used for the diagnosis, treatment, prevention
or alleviation of any disease or any symptom of a disease in human beings,
or for the regulation of the functional states of the human body.

Classification category and registration group

The requirements for registration of pCms are dependent on the
classification category of the pCm under application (not applicable to
transitional registration), and the registration group selected by the
applicant. The classification categories of pCms include the “Established
medicines category”, the “Non-established medicines category”, and the
“New medicines category”. “Health-preserving medicines” and “Other
medicines” are the two categories under the “Non-established medicines
category”. For registration group, the CMB adopted a three-group
registration system, i.e. Groups I, II and III. Applicants should provide
information on the safety, quality and efficacy of the pCm according to
the different registration groups. For pCm in the “Established medicines
category” and “Non-established medicines category”, applicants may choose
to apply for registration in any of the three groups. However, for pCm in
the “New medicine category” (as their compositions, routes of
administration, indications or dose forms are different from traditional
medicines), scientific evidence is required to prove their safety and
efficacy. They may only apply for Group III registration, and need to
fulfill the necessary requirements.

Documents required for registration

The documents required to be submitted for registration of pCms can be
categorized into 4 types, including the general, safety, efficacy, and
quality information.

General information
Applicants should provide information about the person-in-charge of the
company, manufacturer’s license and related information, free sale
certificate (if applicable), master formula, product samples and sales
pack, label and package insert

Information on Safety
Basic safety information to be provided by applicants for registration of
pCm includes: heavy metals and toxic element test reports, pesticides
residue test reports, and microbial limits test reports. Depending on the
registration group, additional toxicity test reports (e.g. acute toxicity
test report), and other test reports (e.g. carcinogenicity test report),
may also need to be provided.

Information on Efficacy
The information on efficacy to be provided by applicants for pCm
registration includes interpretation and principle of formulating the
prescription, in which descriptions of the properties, flavours, channel
tropism, functions, indications, and compatibility of the medicines, and
analysis of the prescriptions and their clinical applications should be
illustrated. Depending on the classification category and the registration
group, reference materials on product efficacy, principal pharmacodynamics
studies reports, general pharmacological studies report, clinical trial
protocols and summary reports may also need to be provided.

Information on Quality
The basic information on product quality to be provided by applicants for
registration of a pCm includes the manufacturing method, the
physiochemical properties of the crude drugs, the product specifications,
the method and certificate of analysis, and the stability test report.

The above requirements are applicable to the seven pCms listed in your
recent query to the Food and Health Bureau.  For details on the
classification categories and registration requirements, you may refer to
the “Application Handbook for Registration of Proprietary Chinese
Medicines” and the technical guidelines for registration of pCms, which
can be downloaded from the website of the Council

Yours sincerely,
(Miss Irene HO)
for Director of Health

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