The regulatory regimei Classification
There are seven Acts that govern specific products, in particular, drugs, medical devices, foods, cosmetics, hazardous substances, narcotics and psychotropic substances. The products (and their variations) governed by each specific Act are laid out in the introductory section of each Act.
The Acts provide for definitions and classifications of products. For example, the Drug Act provides a broad definition of a drug that covers details such as substances recognised in a pharmacopoeia approved by the Minister and intended for use in the diagnosis, treatment, relief, care or prevention of human or animal disease. Once it is clear that a particular product has the characteristics of a drug (and more importantly that it does not have characteristics that are excluded under the Drug Act), there are then further subclassifications (such as modern drugs and herbal drugs).
For medical devices, the Medical Device Act provides clear definitions for medical devices and the main focus for product classification is on the manufacturer's intended use, which must be clearly declared by statements made on the product label or leaflet issued by the manufacturer.ii Non-clinical studies and animal testing
The Institute of Animals for Scientific Purpose Development, an agency of the National Research Council of Thailand, is the body responsible for the use of animals for scientific purposes. Non-clinical testing on animals is regulated by the Animals for Scientific Purposes Act, BE 2558 (2015).
In addition to the Act, the National Research Council of Thailand has issued Ethical Principles and Guidelines for the Use of Animals. The Guidelines set standards for animal care and management of animal health, and only allow techniques that minimise the stress and pain endured by animals during testing.iii Clinical trials
There is no specific Thai law governing human clinical trials. However, in practice, clinical trials in Thailand should follow international codes of ethics, such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and Good Clinical Practice (ICH/GCP). In 2000, the FDA translated the ICH/GCP into Thai for ease of reference and to act as guidelines.
To facilitate clinical trials, the FDA has issued a Notification that deals with the importation of drugs for clinical trial purposes. The Notification outlines the requirements for an Ethics Committee to consider requests for importing drugs into Thailand for clinical research. If approved, these drugs are then exempted from the need for drug formula registration with the FDA, until such time as the manufacturer decides to commercially sell or distribute the drug in Thailand.
Research participants must be volunteers and a high level of care has to be used. A research project has first to be approved by the Ethical Review Committee for Research in Human Subjects (EC), which is under the purview of the MOPH. The EC has put in place Guidelines and Procedure for Research on Human Subjects; however, these are not enforced by law and most research institutions have their own sets of guidelines and procedures.
The requirement for informed consent is covered by Section 9 of the National Health Act, which requires that volunteers must provide written consent before participating in any medical research. Volunteers can revoke their consent at any time. Informed consent is not limited to a one-off signature on a piece of paper, but is a continuing process.iv Named-patient and compassionate-use procedures
Unlike some countries, there is no specific legislation or regulation that deals with named-patient production or importation. Neither are there any specific exceptions on product registration for the purposes of named-patient usage stipulated in the Drug Act.v Pre-market clearanceDrugs
Pre-marketing control covers product registration and related licences and permits (such as manufacturing facilities, product quality assurance and advertising).
The pre-marketing control of drugs by the FDA is divided into two main steps. The first step is that the Drug Act requires that those who wish to import, manufacture or sell drugs in Thailand must obtain an appropriate licence.
The second step is for the applicant to apply for the relevant product (formula) registration licence.
The application file is then reviewed in detail by the FDA to check the quality, efficacy and safety of the drug. If the application file is complete, it requires a final signature for approval.
It takes approximately 280 working days for a drug registration licence to be granted, according to the current citizen manual, and the application file must be submitted using the eCTD (electronic Common Technical Dossier) only. The first approval of a new drug is a conditional approval only, which allows the new drug to be sold solely through hospitals and medical clinics, and is subject to at least a two-year safety monitoring programme (SMP). Reports from the SMP during these two years will then be considered when a subsequent application is made for an unconditional approval. If granted, an unconditional approval will also allow the drug to be sold through retail pharmacies.
The dossier requirements for drug applications must follow the Association of Southeast Asian Nations (ASEAN) Harmonisation rules that came into effect on 1 January 2009. This means that under the new rules of the ASEAN Harmonisation on Pharmaceutical Registration, manufacturers wishing to sell their products in ASEAN countries are required to prepare dossiers in a common format in accordance with the ASEAN Common Technical Requirement and the ASEAN Common Technical Dossier.Medical devices
Medical devices are categorised into three subcategories (see Section II.xi for product classifications) and each category has its own specific pre-marketing procedures.
As a general first step, a local manufacturing facility requires a manufacturing licence and an importer requires an import licence.vi Regulatory incentives
Thailand does not have specific laws on data exclusivity for the protection of an originator's drug registration data from other companies submitting applications to the FDA to register generic versions of the drug in question. There is a Trade Secrets Act of general application under which the MOPH has issued a Regulation. However, this Regulation is of limited use as it does not prevent the FDA from referring to and relying upon an originator's registration data when considering a subsequent generic application. The scope of this Regulation is limited to pharmacopoeia registration information related to modern drugs that use new kinds of chemical substances that have not ever been approved for registration in Thailand.
The purpose of the Regulation is to allow an applicant who submits the pharmacopoeia registration information, as part of the drug registration process, to also submit an application requesting that the FDA keep the trade secrets of the pharmacopoeia registration information confidential. If the confidentiality application is approved under the Regulation, the FDA is required to keep the information confidential for five years from the approval date. It is important to note that the protection granted under this regulation is limited to the maintenance and safe-keeping of the pharmacopoeia registration information as a trade secret.
Thailand has no special provisions to encourage the development of products for rare diseases and no 'orphan drug' programme.vii Post-approval controls
Post-marketing controls aim to monitor manufacturing facilities and product quality and safety after approval has been granted. The objective is to ensure there is continuing compliance with both previously approved requirements and current standards, legislation and notifications. Occasionally, the FDA randomly selects and spot checks products in the market and tests them to ensure that the ingredients are true to the pre-approved product licence label. The surveillance programme for consumers' safety works hand in hand with the operators' required pharmacovigilance to protect consumers from dangerous products. The FDA uses research and epidemiological data, which includes technical information on adverse events.
Manufacturing facilities that have previously been approved are inspected to ensure continuing compliance with the good manufacturing practices (GMP) certification and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an extension of the Pharmaceutical Inspection Convention.
Currently there are no laws or regulations regarding the transfer of ownership of medical device licences and a transferee would have to apply for a new licence.
Post-marketing controls on medical devices involve surveillance of the medical devices to prevent injury that are on the market, and the development of regulatory standards and product improvement. Various sources of information are used for post-marketing surveillance (PMS).
To ensure that Thailand's PMS procedures and requirements meet ASEAN standards, the MOPH has issued a notification on the procedures for the submission of a Device Defect Report or Adverse Event Report and the ensuing Field Safety Corrective Action Report, which came into effect on 4 November 2016.
As an ASEAN Member State, Thailand has applied and harmonised its standards in compliance with the ASEAN Consultative Committee for Standards and Quality-Medical Device Product Working Group, which has set up a Post-Marketing Alert System to keep track of medical devices on the market that are unsafe.viii Manufacturing controls
An entity that intends to manufacture drugs in Thailand must apply for a manufacturing licence from the FDA. A factory licence from the Ministry of Industry will have to be obtained before applying for the manufacturing licence. A manufacturer of modern drugs must have at least two pharmacists to manage the operation and monitor drugs at the premises during business hours. All manufacturers are required to have GMP certification that complies with the standards of PIC/S.
An entity that intends to manufacture any category of medical device in Thailand must have its business premises inspected and registered with the FDA and obtain a manufacturing licence. Additionally, procedures to register or notify each type of medical device is required.ix Advertising and promotion
Each category of drugs and medical devices has different requirements regarding advertisement and promotion. Some products are more restricted than others when it comes to advertising. For example, specially controlled drugs and dangerous drugs cannot be advertised to the public. Several medical devices can only be advertised to healthcare professionals, while other medical devices can be advertised to the general public. The specific requirements regarding advertising and promotion are prescribed by the FDA.
There are two fundamental requirements for advertising drugs and medical devices.
- First, both drugs and medical devices must meet pre-approval requirements for advertising. Before advertising any drug or medical device by any means, the content and wording that will be used in the advertisement must be submitted to the FDA for approval.
- Second, the content of advertisements must comply with the conditions set by the FDA and must not contain information that is false, exaggerated, misleading or different from the details as registered with the FDA. An advertisement must not use information that cannot be proven. In the approval process, supporting evidence such as scientific or academic information must be provided.
In addition to the main requirements set out in the Drugs Act and the Medical Device Act there are several other laws and regulations of relevance, including the Consumer Protection Act, BE 2522, the Direct Sales and Direct Marketing Act, BE 2545, the Medical Professionals Act, BE 2525, and the ASEAN Harmonisation Guidelines covering topics such as labelling requirements and interaction with medical professionals.x Distributors and wholesalersDrugs
To sell drugs, a selling licence relevant to the type of business in question is required from the FDA; this may be a wholesale licence, a retail licence or a pharmacy licence. The main condition is that the seller must have such facilities as are prescribed by the ministerial regulations. A pharmacist must be in attendance during business hours to dispense drugs and to monitor activities.
A selling licence is also required for the sale of certain types of medical devices.xi Classification of products
The Drug Act generally categorises drugs as modern, traditional, dangerous, specially controlled, household, packaged (other than those categorised as dangerous or specially controlled) and herbal. The Minister of the MOPH, on the advice of the Drugs Committee, has the authority to classify drugs into one of these categories by making an announcement in the Royal Gazette.
However, in practice, for licensing purposes, the FDA classifies drugs into seven main categories: new, new generic, modern, traditional; herbal, household and orphan. Each category of drugs has different restrictions and requirements.
As is the case with a number of other South East Asian countries, the incidence of self-medication in Thailand is generally more prevalent than in some Western countries. For example, what would commonly be regarded as prescription-only items in certain other jurisdictions are available for purchase in retail pharmacies in Thailand without the need for a doctor's prescription. Generic substitution is accepted practice.
The Medical Device Act classifies medical devices into three categories, each with different restrictions and requirements. The Minister of the MOPH, on the advice of the Medical Devices Committee, has the authority to classify medical devices based on risk and safety to consumers, and the classifications are subject to change as announced.xii Imports and exports
An entity that intends to import drugs into Thailand must obtain an import licence from the FDA.
An entity that intends to import any category of medical device must have its business premises registered with the FDA.
Under the Drugs Act and the Medical Device Act, there is no requirement for a licence to export drugs or medical devices. However, an export certificate (similar to a free sale certificate) may be required by Thai Customs.
A business in Thailand that wishes to manufacture medical devices in accordance with the quality standards, labelling standards or other details specified by an overseas purchaser, and to export those devices without selling them in Thailand, can apply for a manufacturing-for-export licence that will expedite the application process and make it faster than a normal manufacturing licence application process. The procedures and conditions for obtaining a manufacturing-for-export licence are as prescribed by the FDA.xiii Controlled substances
Narcotics and psychotropics are listed under various categories and are either restricted or subject to strict licensing requirements.xiv Enforcement
Owing to personnel limitations, the enforcement phase is initiated when spot checks in the market reveal that products are not up to standard, or when a complaint is made to the FDA about concerns regarding drugs or medical devices. Some follow-up questions might be asked and proof requested from the complainant to determine the legitimacy of the complaint. The FDA will then take over and begin by gathering preliminary information about the product and the responsible person. The product in question will then be analysed and the results will be compared with the product licence and registrations, and any relevant legislation, to determine infractions. The investigation and inspection procedures applied by the FDA vary from case to case. If necessary, the FDA may enlist the police for assistance. The penalties for infractions are provided in the relevant legislation. Additional enforcement actions required for medical devices are covered above in the post-marketing subsections.