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Introduction to Drug Regulatory System in Hong Kong

 

In Hong Kong the Department of Health (DH) is responsible for overseeing the safety, efficacy and quality of all medicines marketed in Hong Kong. Medicines can be divided into Chinese medicines and non-Chinese medicines (or western medicines) as they are regulated under difference Ordinances, i.e. Chinese Medicine Ordinance (Cap. 549) and Pharmacy and Poisons Ordinance (Cap.138) respectively.

Both Chinese herbal medicines and proprietary Chinese medicines are regulated by the Chinese Medicine Division of the DH. For more detail, please refer to http://www.cmd.gov.hk.

Apart from the Pharmacy and Poisons Ordinance, the Import and Export Ordinance (Cap.60), the Undesirable Medical Advertisements Ordinance (Cap. 231), the Antibiotics Ordinance (Cap. 137) and the Dangerous Drugs Ordinance (Cap. 134) also provide regulations in the control of medicines in Hong Kong.

This article gives an introductory overview of the existing drug regulatory framework in Hong Kong.

 

Pharmacy and Poisons Ordinance (Cap. 138)

Registration of medicines

According to the laws of Hong Kong, medicines (pharmaceutical products) must be registered with the Pharmacy and Poisons Board (PPB) prior to their sale in the market. “Pharmaceutical product” means 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.

Pharmaceutical products are required to conform to the standards on safety, efficacy and quality before they can obtain registration. Such requirement aims at providing the public with safeguard on safety, efficacy and quality of medicines available in the market. Therefore, the applicant has to provide a set of information including production formula, product specification, laboratory report and manufacturer licence in his/her application for registration for the approval of the PPB.

Upon registration, the medicine will be given by the PPB a registration number, such as HK-12345, which is required to be printed on the medicine label. Members of the public can therefore check from the registration number on the label to see if the medicine is registered or not. This website also provides a search engine which links to the medicine registration database for members of the public to verify the registration status of a medicine.

Classification and control of drugs

According to the laws of Hong Kong, medicines are classified into three main categories according to the severity of the diseases they intend for and the magnitude of the side effects they cause. Medicines in different categories have to be sold in different registered retailers under different specified conditions outlined as follows:

Category 1:

Medicines in this category must be dispensed and sold on doctor’s prescription in registered pharmacies under the direct supervision of registered pharmacists.

Examples include antihypertensive medicines, oral antidiabetics and tranquillisers. Such “prescription medicines” are used to treat serious diseases. Incorrect dosage or improper use may bring about serious health damage.

According to the Pharmacy and Poisons Ordinance, medicines in Category 1 should be labelled with the words “Prescription Drug 處方藥物”.

 

Category 2:

Medicines in this category do not require doctor’s prescription but have to be sold in registered pharmacies under the direction and supervision of registered pharmacists. The method of use and dosage must be followed to avoid health risks.

According to the Pharmacy and Poisons Ordinance, medicines in Category 2 should be labelled with the words “Drug under Supervised Sales 監督售賣藥物”.

 

Category 3:

Medicines in this category can be sold in pharmacies or medicine stores without resident pharmacists and examples include drugs for common cold, antipyretics and painkillers. They are often used to treat or alleviate minor illnesses and their side effects are fewer. Despite this, members of the public have to bear in mind that improper use of such medicines may also bring about undesirable side effects. If in doubt, consult your doctor and refrain from discriminate self-medication.

Licensing of medicine dealers

In general, the drug supply chain consists of manufacturers, wholesalers and importer/exporters, and retailers. They are all subject to licensing control under the Pharmacy and Poisons Ordinance.

Manufacturers

Under the Ordinance, all pharmaceutical manufacturers in Hong Kong must obtain a licence before commencing operations. They have to comply with the Hong Kong Good Manufacturing Practices (GMP), which is part of quality assurance to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use. DH conducts regular inspections against the licensees to ensure that they are in compliance with GMP and other regulatory requirements.

Wholesalers and importer/exporters

Traders dealing with import/export and wholesale of western medicines require a Wholesale Dealer Licence. Wholesalers and importers/exporters, as well as manufacturers, are required to keep their medicines under suitable conditions. They are also required to set up a system that will enable the effective recall of medicines from the market when the products are found to be dangerous or injurious to health. DH conducts regular inspections against the traders to ensure their compliance with the regulatory requirements.

Retailers

Under the Ordinance, there are two kinds of medicines retailers: Listed Seller of Poisons (LSP) and Authorized Seller of Poisons (ASP). DH conducts, on average, two unannounced inspections against medicine retailers to ensure their compliance with legal requirements.

  • Listed Seller of Poisons (LSP)
    LSPs, commonly known as “medicine companies”, are only allowed to sell the category 3 medicines.

  • Authorized Seller of Poisons (ASP)
    ASPs, commonly known as “pharmacies” or “dispensaries”, are authorized to sell all 3 categories of medicines under specific conditions. They are distinguished from other unlicensed drug retailers or LSPs by displaying the “℞” logo. The name, the certificate of registration and working hours of the pharmacist must be displayed in a conspicuous location inside the ASP. The Ordinance requires that medicines in categories 1 and 2 must be sold under the supervision of registered pharmacists at the premises of ASP. Illegal sale of controlled medicine is an offence and subject to a maximum penalty of $100,000 fine and 2 years’ imprisonment.

Import and Export Ordinance (Cap. 60)

Under the Import and Export Ordinance, every consignment of importation or exportation of pharmaceutical products requires a licence.

Undesirable Medical Advertisements Ordinance (Cap. 231)

The   Undesirable   Medical   Advertisements   Ordinance   prohibits   the advertisements likely to lead to the use of any medicine, surgical appliance or treatment for the purpose of treating human beings for, or preventing them from contracting listed diseases or conditions or purposes specified in Schedules 1 and 2 of the Ordinance, and prohibits/restricts advertising of six groups of claims specified in Schedule 4 for all orally consumed products, in order to prevent the adverse effects of improper self-medication by members of the public. DH regularly screens medical advertisements from different media and actions will be taken against those who contravene the Ordinance.

Antibiotics Ordinance (Cap. 137) and Dangerous Drugs Ordinance (Cap. 134)

Some medicines may be classified as antibiotics or dangerous drugs under the Antibiotics Ordinance and Dangerous Drugs Ordinance respectively. Both antibiotics and dangerous drugs are prescription medicines and they could only be sold on doctor’s prescription in registered pharmacies under the supervision of a registered pharmacist.

Monitoring of marketed drugs

Apart from the above regulatory control, DH has a market surveillance system in place to monitor the safety, efficacy and quality of drugs. DH collects marketed medicines via different channels, including the Internet, for analysis. If a product is found to be not of the required quality or adulterated with harmful substances, public announcement will be make as soon as possible to alert and advise members of the public.

 
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