Introduction
The Thai Food and Drug Administration (FDA), under the Ministry of Public Health (MOPH), is responsible for protecting the health of consumers by ensuring the safety, quality and efficacy of health products, including food, pharmaceuticals, medical devices and cosmetics, in Thailand. The FDA has five main areas of focus: (1) pre-marketing, (2) post-marketing, (3) product surveillance, (4) product education for the consumer and (5) cooperation with other health-related agencies. Presently, the FDA has close to 500 staff members who run the agency, including pharmacists, nutritionists, lawyers and other health professionals.
Pharmaceuticals
Thailand Pharmaceutical Registration
The Thai FDA regulates pharmaceuticals through the Drug Act of B.E 2530. The Drug Act requires a company to obtain a license in order to import, sell or manufacture drugs in Thailand. Specifically, licenses are required for the following activities:
- Importing, manufacturing or selling modern medicines
- Acting as a wholesaler of modern medicines
- Selling modern medicines in sealed packages that are not classified as dangerous or specially-controlled medicines
- Importing, manufacturing or selling traditional medicines
- Selling veterinary medicines in sealed packages
The Thailand pharmaceutical registration process has been set up to ensure the safety, quality and efficacy of pharmaceutical products in Thailand. According to the Drug Act, for product registration purposes, pharmaceuticals are divided into three categories: (1) new medicines, (2) generics and (3) new generics. New medicines are classified as products with new chemicals, chemical combinations, indications, delivery systems or dosage forms. New generics include medicines with the same active ingredients, doses and dosage forms as those of new compounds registered after 1992. Product registration licenses are valid for five years.
New medicines will require a complete dossier for Thailand pharmaceutical registration, while generics will require dossiers containing only product details, manufacturing and quality control information. New generic drug applications will need to include bioequivalence studies in addition to the requirements for a generic drug application. The Drug Control Division of the MOPH, or a provincial public health office, is responsible for reviewing and issuing registration licenses. Prior to granting a license, the health authority may conduct an inspection of the manufacturing site to ensure GMP compliance.
Labeling
Some of the labeling requirements for modern drugs include:
- Drug name
- Quantity
- Active ingredient(s)
- Lot/batch number
- Manufacturer’s name and province
- Date of production
- Drugs classified as Specially-controlled drugs, dangerous drugs or common household drugs should be labeled as such
- Expiration date
Advertising
Pharmaceutical advertisements in Thailand need to be approved by the health authorities prior to use. Drugs classified as household remedies can be directly advertised to the general public. Conversely, prescription drugs may only be advertised to healthcare professionals. Recently, an influx of drug advertisements has appeared on the Internet and the large majority of these advertisements were not approved by the FDA. Therefore, the FDA is focusing more effort on the monitoring of drug advertisements.
Post-Marketing Surveillance
The Medical Sciences Department under the MOHW is the main authority responsible for ensuring the quality and safety of drugs on the market in Thailand. Samples of products on the market are regularly tested at the Medical Sciences Department laboratory. Other local laboratories also conduct post-marketing surveillance for the MOHW by performing the following measures:
- Safety monitoring of new drugs on the market
- Handling product complaints
- Monitoring drugs on the market for unexpected health risks
- Informing the public of risks posed by specific drugs; investigate the cause of the risk; if necessary, remove the drug from the market
- Inspect manufacturing sites for GMP compliance
- Monitoring manufacturing process changes
Medical Devices
Overview
The medical device market in Thailand is worth close to $500 million and for the past several years, it has been expanding around 10 percent annually. Imported medical devices continue to make up more than half of the total market share, as local manufacturers tend to concentrate on devices with less advanced technology in comparison to many of the foreign importers. Some locally-produced devices include disposable items, such as test kits, orthopedic products, syringes, etc. Foreign medical device companies importing their products into Thailand often focus their sales on respiratory devices, dental products, implantable devices, diagnostic test kits and others.
Public and private hospitals are some of the largest users of medical devices in Thailand. There are approximately 1,000 public and 400 private hospitals in the country. While public hospitals are limited to their own budget (without a subsidy from the government), private hospitals offer a much larger opportunity for increased medical device demand.
Prior to 1988, Thailand did not have any regulations pertaining to medical devices. Oftentimes, the MOPH referred to the Drug Act when regulating medical devices. However, the control measures of the Drug Act were limited when applied to medical devices. To better ensure the quality, efficacy and safety of medical devices in Thailand, the Medical Device Act was implemented on May 23, 1988. Soon after, on June 22, 1990, the Medical Device Control Division was created under the FDA.
Importing Devices into Thailand
The Thai FDA classifies medical devices into three types: License Medical Devices (Class I), Notification Medical Devices (Class II) and General Medical Devices (Class III). Please note that the Thai FDA classifies their devices in reverse order, with the most regulated devices designated as Class I; the least regulated devices are Class III.
General Medical Devices only require the importer to supply a Free Sale Certificate from the United States, Europe, Japan, China or Australia to the Thai FDA. Class II, or Notification Medical Devices, need to be registered with the FDA. Product information, including production processes, packaging, labeling, storage conditions, etc. should be supplied. A Free Sale Certificate is also required. Finally, Class I devices require FDA approval in order to obtain an import license. To obtain approval, the product manufacturer should demonstrate compliance with Thai Industrial Standards Institute standards (based on ISO). The FDA may also require testing for some devices.
Typically, the import license application process will take about three months to complete. The Thailand medical device registration will generally be in the name of the local agent or distributor, not in the name of the foreign manufacturer. If the foreign manufacturer chooses to change their distributor, the import license will have to be renewed under the name of the new distributor. Once the import license has been granted by the FDA, the Thai Customs Office will be notified to permit clearance of the product when it arrives at the port.