I INTRODUCTION

The Food and Drug Administration (FDA), established by the Ministry of Public Health (MOPH), is the government administrative and regulatory body governing consumable products in Thailand. Consumable products include foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances available in the country.2 To ensure the safety, quality and efficacy of consumable products, the FDA controls, regulates and administers the manufacture, distribution, advertisement and other matters in relation to the consumable products through five main divisions: the Bureau of Foods, the Bureau of Drug Control, the Medical Device Control Division, the Cosmetic and Hazardous Substance Control Division and the Narcotics Control Division.3

The FDA's five main roles and responsibilities are pre-marketing control, post-marketing control, development of a surveillance programme for consumers' safety, consumer education and provision of technical support and cooperation with other agencies.

By law, certain important issues are decided by committees, whose members – all experts in their respective fields – are appointed by the Minister of Public Health. Currently, there are seven committees, for: foods, drugs, psychotropic substances, narcotics, medical devices, cosmetics and hazardous substances. In addition, to support the development of drugs, foods and chemical substances, the Cabinet has appointed three additional committees, which are the National Drug Committee, the National Food Committee and the National Chemical Safety Committee.4

II THE REGULATORY REGIME

i Classification

The consumable products under the responsibility of the FDA are each governed by eight specific Acts:5 the Drug Act B.E. 2510 (1967); the Psychotropic Substance Act B.E. 2518 (1975); the Food Act B.E. 2522 (1979); the Narcotic Act B.E. 2522 (1979); the Emergency Decree on Prevention of Abuse of Volatile Substances B.E. 2533 (1990); the Hazardous Substance Act B.E. 2535 (1992); the Medical Device Act B.E. 2551 (2008); and the Cosmetic Act B.E. 2558 (2015), issued specifically for the enforcement, supervision and control over the use, manufacture, distribution, import, export, advertisement, suspension and/or revocation of required licence, imposition of penalties in case of violation of the act, and determination of governmental fees of the consumable products under the responsibility of the FDA. Each specific Act provides a definition and classification (if any) in its introductory section.

The decisions on classification and categorisation of consumable products into different types or subcategories are undertaken by each responsible Bureau or Department under the control of the FDA.6 For instance, the classification and categorisation of drugs is undertaken by authorised officers of the Bureau of Drug Control. If a product is considered as a 'drug' under the definition set forth under the Drug Act, it is then further sub-classified into different categories of drugs (e.g., modern drug or traditional drug).

ii Non-clinical studies

Studies of animals are governed by the Animals for Scientific Purposes Act B.E. 2558 (2015). The implementation and enforcement of this Act is carried out by the Supervisory and Promotional Committee on the Use of Animals for Scientific Purposes. This Act aims to raise awareness about the ethics of, and impose certain ethical standards on, animal testing, as well as to ensure that the testing will be carried out under proper standards, implementation and monitoring.

The Supervisory and Promotional Committee on the Use of Animals for Scientific Purposes issued a Notification determining ethics for the use of animals for scientific purposes. The ethics set forth under such Notification clearly promote the value of life of animals, and clearly specify that the use of animals for scientific purposes can be undertaken only when the users have thoroughly considered that the experiment in question shall be for the maximum benefits for the development of humans' and animals' lives, the development of academic progress, or both. After the end of a scientific experiment, the animal subjects shall be put to death in a peaceful manner to promote animal welfare and humane treatment.7

iii Clinical trials

Currently, there is no regulation outlining guidelines for conducting clinical trials. However, according to Section 9 of the National Health Act B.E. 2550 (2007), if a public health professional practitioner demands to use a service receiver as a subject of an experiment in their research, the written consent of the service receiver shall be granted in advance, and such consent can be revoked by the service receiver at any time.

In addition to the National Health Act, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and Good Clinical Practice (ICH/GCP) which was translated by the FDA in 2000, is used as guidance for conducting clinical trials in Thailand. Although this guidance does not have legal enforceability in Thailand, the criteria for the independent ethics committee or institutional review board for considering clinical trials relating to drugs shall be in line with such guidance.8

iv Named-patient and compassionate use procedures

There are no regulations permitting the distribution of medicines or medical devices without prior issuance of a marketing authorisation or other permission for commercial distribution. Thailand does not have exceptions for the registration of named-patient and compassionate use.

v Pre-market clearance

Under the Drug Act, pre-market clearance covers three main steps: licensing, registration and advertising control.

The Drug Act requires that a person who wishes to sell, produce or import drugs into Thailand obtain a licence from the FDA. The government fee for each licence varies depending on the type of licence and product from between 300 and 10,000 baht.9 The approval process will take 10 to 30 days depending on type of licence and product. In addition, such person shall also register the drug formulas with the competent official.10 The registration procedure is to ensure efficacy, safety and quality of drugs sold in Thailand. Upon receipt of a drug registration certificate, the drug can be lawfully marketed. Note that the application shall be submitted to the FDA upon making a reservation for the submission via the FDA's website, phone contact or walk-in contact. However, the registration of certain drug formulas (i.e., pharmacopoeia with new chemical entities) shall be submitted using the eCTD (electronic Common Technical Dossier) only.11 The consideration process shall be approximately 220 working days and the applicant shall prepare a fee of 500 to 2,000 baht for the registration. In addition, for the registration of a new chemical entity or new biological entity, the applicant shall prepare a consideration fee for the total amount of 185,000 baht. The administrative date and product information as well as the documents specifying the quality of the drugs shall comply with guidelines set forth by the FDA, which follows the rules of the ASEAN Harmonization on Pharmaceutical Registration. The newly approved drug formulas shall be monitored and subject to at least a one-year safety monitoring programme (SMP) depending on the risk level of the drug.12

Moreover, advertisement of any drug shall be approved by the FDA before being disseminated. The process will take 15 to 30 days.

Under the Medical Device Act, medical devices are categorised into three subcategories, each with different prerequisite obligations.13 Generally speaking, though, any person wishing to import medical devices is required to either obtain a prior licence, notify the relevant authorities, or notify and register the medical device prior to the importation, as the case may be.14

vi Regulatory incentives

The Trade Secrets Act contains a provision governing the duties of the state to maintain trade secrets of drugs, which are in the form of testing results or information of drugs which is prepared, discovered or created by an applicant, and such applicant has requested the state agencies to maintain the information as trade secrets.15 However, under such provision, only one notification was issued specifically to protect pharmacopoeia information of modern drugs, which use new chemicals that have never been registered in Thailand.16 The notification provides guidelines on the safe keeping of the approved and registered pharmacopoeia information as trade secrets for five years from the approval date.17

Thailand has no special provisions to encourage the development of products for rare diseases, diseases that are prevalent in developing countries, or paediatric use.

vii Post-approval controls

The Post Marketing Bureau of Drug Control, under the control of the Drug Control Bureau, is mainly responsible for the control and supervision of post-approval controls. The Post Marketing Bureau of Drug Control has two main duties: to monitor manufacturing facilities and drug safety and quality after the applicant has obtained the required approval from the FDA. Manufacturing facilities that have been approved are inspected in accordance with the relevant Ministerial Regulations and Notifications. Facilities must be in compliance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S).18 For the monitoring of product safety and quality, officers of the Post Marketing Bureau of Drug Control are vested with the authority provided by the relevant Act, Notifications or Ministerial Regulations to conduct certain actions to ensure that drugs approved for distribution are safe and comply with the required standards under the law. For instance, a Notification issued under the Medical Act allows the officers to order the manufacturer, importer or distributor to recall unsafe drugs, or provide such drugs to the officers for further inspection and disposal.19

For medical devices, the Medical Device Act provides obligations to be complied by manufacturers, distributors and importer.20 Post-market controls on medical devices involve surveillance of medical devices to prevent injury that may be the result of the use of the medical device, as well as to allow the users the opportunity to file a complaint in relation to the medical device for the FDA's further inspection.21 In addition, a Notification was issued to provide procedures for the submission of a device defect report or adverse event report as well as the ensuing field safety corrective report.

viii Manufacturing controls

As mentioned in subsection v, the Drug Act requires that any person who wishes to manufacture drugs in Thailand obtain a licence from the FDA.22 In this regard, the applicant shall provide the required evidence (i.e., the floor plan of the manufacturing facility, which is approved by the FDA, evidence of ownership over the assets and properties, affidavit if the applicant is a juristic person, and other required evidence, such as factory licence or building construction permit if the facilities fall within the size and manufacturing power as required under the relevant laws).23 After obtaining a licence for the manufacture of modern drugs, the manufacturer must have at least two pharmacists to manage the operations and to monitor drugs at the premises during business hours.24

Regarding medical devices, any person wishing to manufacture any category of medical device in Thailand must have its place of business operation registered with the FDA25 and also obtain a manufacturing licence.26

ix Advertising and promotion

The Consumer Protection Act generally governs the content of advertisements as well as labelling requirements. However, the Drug Act and Medical Device Act specifically contain chapters governing the advertisement of drugs and medical devices respectively.27 Both Acts set forth two fundamental requirements for advertising drugs and medical devices.

First, a party must obtain prior approval for the content of the advertisement before such advertisement can be disseminated.28 In addition, there is also an obligation to obtain an advertising licence for the purposes of advertisements that contain information related to medical devices.29

Second, both Acts provide guidelines set forth by the FDA, whereby the content of an advertisement shall not contain information that is false, exaggerated, misleading, or different from the details approved by the FDA.30

In addition to the Drug Act and the Medical Device Act, other rules and Ministerial Regulations issued under both Acts provide additional requirements as to the advertisement of drugs and medical devices. For instance, the FDA issued a rule governing presentation of drug names, drug properties, and recommendations for usage and warnings.31 The FDA also issued a Notification that provides details regarding prohibited content and other requirements in the advertisement of medical devices, and rules and guidelines for the references to academic studies or research to support information in advertisements related to medical devices.32

x Distributors and wholesalers

The sale of modern drugs is prohibited unless a licence has been granted by the FDA.33

The Notification Re: Permission and Issuance of a License to Sell Modern Drugs B.E. 2556 (2013) prescribes the application form and other obligations that an applicant must comply with in order to receive a distributing licence or a wholesaler licence. Generally, depending on the type of licence, the facilities for distribution or storage of drugs must be in compliance with the Notification. A distributor or wholesaler is also required to produce purchase reports, as well as to generate sales reports for submission to the FDA as required. There are also other obligations that must be complied with (i.e., the distributor shall have a pharmacist present during business hours to distribute drugs and monitor activities).

Distribution of medical devices is prohibited unless a licence for the distribution of such medical device has been granted.34 The Notification Re: the Permission and the Issuance of Medical Device Distribution Licences B.E. 2555 (2012) was issued to govern the issuance of licences and imposition of obligations on the applicant.

xi Classification of products

Drugs are categorised as modern, traditional, dangerous, specially controlled, external-use, site-specific, household, packaged, and herbal.35 The MOPH, with advice from the Drug Committee, has the authority to classify drugs into one of these categories by making an announcement in the Royal Gazette.36

The Medical Device Act provides classification of medical devices into different categories each with different restrictions and requirements.37 The MOPH, with advice from the Medical Device Committee, has the authority to classify medical devices based on risk and safety characteristics.

xii Imports and exports

An import licence, granted by the FDA, is required to import drugs into Thailand.

Any person wishing to import medical devices is required to register a place of business operations with the FDA.

For exportation, both the Drug Act and the Medical Device Act do not impose an obligation on an exporter to obtain a licence for the exportation of drugs or medical devices. However, in practice, the Thai Customs Department will request an exporter to provide an export certificate. For example, an export of medical device certificate, issued by the FDA, is evidence specifying that the exporter (or the manufacturer) is the owner of the products. Such certificate also indicates the market status, and shows that such person has already obtained and complied with the requirements of the law in relation to the medical device.38

xiii Controlled substances

The Narcotics Control Division has control over import, export, commercial sale and possession of narcotics and psychotropic substances.39 It is also responsible for the approval, revocation and suspension of licences for import, export, commercial sale, and possession of narcotics and psychotropic substances. For instance, the Narcotics Act provides that no person shall import, export, commence commercial sale of or possess dangerous narcotics such as heroin.40

xiv Enforcement

One of the main responsibilities of the FDA involves surveillance of products in order to maintain product quality and standards, and to prevent violation under the Drug Act and the Medical Device Act. In this regard, FDA officers will, from time to time, initiate random spot checks to ensure that the products (i.e., drugs and medical devices) remain in compliance with the law. If a spot check reveals any failure to comply with the law, or in the case of a complaint made to the FDA, the enforcement phase will commence, which could lead to penalties for the violation as provided in the aforementioned Acts.

III PRICING AND REIMBURSEMENT

In Thailand, procurement by government agencies, including public hospitals, is subject to the criteria and requirements under the Public Procurement and Management of Supplies Act, B.E. 2560 (2017). In this regard, drug prices for public hospitals are prescribed by the National Drug System Development Committee. The latest list was announced in the Government Gazette on 22 April 2019.

Regarding reimbursement, Thailand has three types of the public health coverage: the Civil Service Welfare Systems for central and local civil officers and their family, Social Security for eligible employees in the private sector, and the Universal Coverage Scheme (UC) for all other Thai nationals.41

The benefits packages, payment systems and funding for each programme are different from one another. The Civil Service Welfare Systems is funded and regulated by the Comptroller General's Department of the Ministry of Finance or the Ministry of Interior (for local officers), Social Security is funded by the Social Security Office, while the UC is funded by the National Health Security Office under the National Health Security Act, BE 2545 (2002).

It is notable that all three programmes universally use the National List of Essential Medicines (NLEM) as a guideline for reimbursable drugs. The NLEM is a list of reimbursable drugs announced by the Drug System Development Committee, including the conditions (or lack thereof) for medical professionals to prescribe reimbursable drugs under the coverage. The drugs outside of the NLEM can also be reimbursed; however, only with a prescription by medical professionals in charge as necessary to cure the patient of a sickness.

IV ADMINISTRATIVE AND JUDICIAL REMEDIES

Under the Drug Act, in the case that a drug licence is not granted or the authority does not renew an existing licence, an applicant has the right to appeal that decision to the Ministry of Public Health within 30 days from receipt of notice that such licence will not be issued or renewed. If an applicant does not appeal that decision within 30 days, the licence will be revoked.

Since there is no specific period for consideration of an appeal under the Drug Act, consideration for such an appeal with be as specified in the Administrative Procedure Act, B.E. 2539, meaning the consideration process shall be completed within 30 days from the date of receipt of the appeal.

For medical devices, if the authority does not issue an establishment registration certificate, licence or specifications declaration receipt, the applicant has the right to appeal the authority's order in writing to the Minister of Public Health within 30 days from the date of receipt of notice of the non-issuance of establishment registration certificate, licence or specifications declaration receipt, as the case may be.

When considering an appeal under the Medical Device Act, the Minister of Public Health shall complete the appeal process within 120 days from the date of receipt of the appeal. If, due to necessity, consideration cannot be completed within such time period, written notice shall be sent to the appellant before the expiry of the time period. The period for consideration of an appeal may be extended for not more than 120 days from the expiry of the initial 120 day consideration time period.

Pursuant to both Acts, the judgment of the Minister of Public Health is considered to be final. However, if the appellant is not satisfied with the judgment of the Minister of Public Health, the appellant has right to file a case with the Administrative Court.

V FINANCIAL RELATIONSHIPS WITH PRESCRIBERS AND PAYORS

Thai law regulates the purchase of medicines and medical devices by the government. For the most part, the organisations that generally make decisions concerning utilisation or reimbursement of medicines and medical devices in Thailand are the Government Pharmaceutical Organization (GPO), the Thai Red Cross Society and public hospitals.

These organisations need to comply with a set of rules regarding the procurement of such products.42 Thus, there should be no financial relationships between product suppliers or prescribers.

Generally, procurement of products can be done by three methods: the general solicitation method, the selection method and the specific method. The general solicitation method can be done through e-market, e-bidding or examination of price.43 The e-market method is used when procurement of products will cost more than 500,000 baht and such products do not have complex or specific characteristic and the details and specifications are provided in the e-catalogue system of the Comptroller General's Department.44 The e-bidding method applies to the procurement of products costing more than 500,000 baht and the specifications are not provided in the e-catalogue system in accordance with the methods specified by the Comptroller General's Department.45 The examination of price method must be done in the case of procurement of products costing more than 500,000 baht and there is no internet connection within the area of the relevant government organisations.46 Under the selection method, a government agency will solicit at least three business operators who possess specific qualifications determined by the relevant agency to submit a proposal, unless there are fewer than three business operators who possess such qualifications.47 Under the specific method, a government agency may solicit a single business operator who possesses specific qualifications determined by the relevant agency to submit a proposal, or to bargain prices where the cost does not exceed 500,000 baht for a single procurement.48

On March 2019, the Committee that analysed issues in regard to public procurement and management of supplies issued guidelines for the purchase of medicines and medical devices for relevant government agencies.49 Under such guidelines, when a government agency intends to purchase medicines or medical supplies under the Thailand National List of Essential Medicines (NLEM) that the GPO or the Thai Red Cross Society produces and distributes, that government agency is required to procure such medicines and medical supplies using the specific method. However, the government agency may purchase such products from any other suppliers when the GPO or the Thai Red Cross Society is not able to produce and distribute the products within the specified period according to the annual plan submitted by the relevant government agency.50

With regard to the purchase of medicines or medical supplies by the private sector, the authorised private sector entity may purchase such products certified by the FDA from any suppliers without restrictions.

VI SPECIAL LIABILITY OR COMPENSATION SYSTEMS

As there is no specific compensation system for persons injured by medicines or medical devices in Thailand, the general principles of law regarding tort and product liability apply.

VII TRANSACTIONAL AND COMPETITION ISSUES

i Competition law

There is no specific rule or law on the settlement of patent disputes between an originator and generic manufacturers provided under intellectual property laws. Also, there is no specific provision targeting drug or medical device markets under the current antitrust law.

ii Transactional issues

There is no specific law governing licensing or strategic collaborations, joint ventures or mergers and acquisitions in relation to medicines and medical devices.

VIII CURRENT DEVELOPMENTS

i Amendment to the Drug Act

Effective as of 16 August 2019, the key amendments to the Drug Act (No. 6) are as follows:

  1. Involvement of experts, either as external organisations, government agencies or private entities both in Thailand or overseas, who meet the requirements set forth by the MOPH, to evaluate academic documents, conduct product analysis, as well as evaluate place of business and operation on behalf of the FDA, in order to facilitate and accelerate the drug approval process.
  2. Payment fee collected from the expert's enrolment shall be kept by the FDA and used for the FDA's operation. This includes development of the FDA's organisation and development of the drug approval process.
  3. The FDA may announce usage or allow usage of foreign and international standards for manufacture, distribution or import of drugs, provided that the international standards adopted shall not be below the standards set forth by the FDA.
  4. Amendment to the validity period of a drug registration licence is seven years from the issue date. In this regard, drug registrations issued before the amendments to the Act became effective will remain valid for a period of between five and nine years depending on the year the drug registration licences were issued.
  5. A revision of the rate of fees in the attachment of the Drug Act was made, whereby the rates of the fees for licences, substitute licences and substitute certificates issued under the Drug Act have been increased.

Draft Ministerial Regulations issued under the amended Drug Act

  1. Draft Ministerial Regulation issued under the amended Drug Act (amendment to the Notification Re: Rules Conditions and Procedures for the Manufacture of Modern Drugs B.E. 2546). The key amendments are as follows:
    • update to the process and evidence required for the application for a licence to manufacture modern drugs;
    • establishment of additional obligations for an authorised person to manufacture modern drugs (i.e., provide an annual report regarding the manufacturing of modern drugs);
    • sets requirements regarding the renewal of a licence to manufacture modern drugs; and
    • allows authorised persons to increase their place of business for the storage of drugs.
  2. Draft Ministerial Regulation issued under the amended Durg Act (amendment to the Notification No. 16 issued under Drug Act B.E. 2510). The key amendments are as follows:
    • provides additional requirements to be followed by an authorised person (i.e., to comply with rules and regulations on the keeping of drugs and the distribution of drugs);
    • allows the Ministry of Public Health to determine characteristics and the amount of equipment that is required under Notification No. 16, as well as the rules in relation to the place for drug storage; and
    • provides additional requirements for the renewal of a licence to import modern drugs into the Kingdom.

ii Amendment to the Medical Device Act

Effective as of 27 April 2019, the amendments to the Medical Device Act (No. 2) contain key amendments as follows:

  1. Revision of the definition of 'medical device', as well as to further define the terms 'supporting equipment' and 'informant' in order to comply with the ASEAN Agreement on Medical Device Directive.
  2. Determination and grouping of medical devices or a group of medical devices into different categories based on the level of risk of harm to health, body, or life of humans or animals or impact public health in general. In this regard, different obligations are imposed on different groups of medical devices (i.e., prior approval, and prior notification obligations). This categorisation is made in order to impose further obligations to any person who wishes to manufacture or import medical devices that may cause harm to health, body, or life of human or animals or impact public health in general.
  3. Adjustment of control measures for the import and export of medical devices. The Ministry of Public Health is authorised under the amended Act to determine a place of examination of a medical device to be imported in or exported out of the Kingdom.
  4. Involvement of experts – either external organisations, government agencies or private entities both in Thailand or overseas, who meet the requirements set forth by the Ministry of Public Health – to evaluate academic documents, conduct product analysis, and evaluate place of business and operations and approvals of licences and/or consideration of an application for a licence, notification letters, notification-approval letters, and other matters in relation to medical device on behalf of the FDA, in order to facilitate and accelerate the medical device approval process.
  5. Determination of the validity period and renewal period of the notification-approval letter. In this regard, the notification-approval letter shall be valid for a period of five years from the issue date. In addition, the amendment set forth a rule preventing any person from manufacturing, distributing, importing or exporting certain medical devices until such person has obtained an approval letter.
  6. Revision to the rate of fees in the attachment of the Medical Device Act was made. The revision was made to set a fee rate for the application to receive an approval letter for the manufacture or import of medical devices, and a fee for the registration of the place of import of medical devices.

Draft Ministerial Regulations issued under the amended Medical Device Act

  1. Draft Ministerial Regulation Re: Application and Issuance of Medical Device Licence. The key provisions are as follows:
    • determination of the list of evidence an establishment registrant who wishes to manufacture or import medical devices must provide;
    • licences for the manufacture or import of medical devices shall be renewed using the form provided by the FDA; and
    • the application form, licence form, renewal form and amendment form shall be as provided by the FDA.
  2. Draft Ministerial Regulation Re: Notification and Issuance of Notification-Approval Letter. The Notification will provide a list of evidence required to be submitted to the FDA for any establishment registrant who wishes to manufacture a certain group of medical devices or medical devices that require a prior notification and prior receipt of an approval letter.
  3. Draft Ministerial Regulation Re: Notification of Details and Issuance of Approval of Explanation of Medical Device Letter. The Notification will provide the list of evidence required to be submitted to the FDA for any establishment registrant who wishes to manufacture or import a certain group of medical devices or medical devices that require prior notification.
  4. Draft Ministerial Regulation Re: Determination of Fees in Relation to Medical Devices. This Notification will provide a newly updated list of fees in relation to medical devices.

Footnotes

1 Jessada Sawatdipong is a managing partner, Pranat Laohapairoj is a counsel, and Suphakorn Chueabunchai and Noraseth Ohpanayikool are associates at Chandler MHM Limited.

2 Food and Drug Administration, 'The Roles and Responsibilities of Thai FDA' (Food and Drug Administration 2016), http://www.fda.moph.go.th/sites/FDA_EN/SitePages/Roles.aspx, accessed 2 December 2019.

3 Ministerial Regulation Re: Determination of Organisation Structure of the Food and Drug Administration, Ministry of Public Health B.E. 2552 (2009).

4 Food and Drug Administration, 'Structure' (Food and Drug Administration 2019), http://www.fda.moph.go.th/SitePages/Structure.aspx, accessed 2 December 2019.

5 ibid.

6 Ministerial Regulation Re: Determination of Organisation Structure of the Food and Drug Administration, Ministry of Public Health B.E. 2552 (2009).

7 Chapter 1 of the Notification of the Supervisory and Promotional Committee on the Use of Animals for Scientific Purposes Re: Determining Ethics for the Use of Animals for Scientific Purposes, announced on 29 February 2016.

8 Clause 6.3 of the Notification of the Drug and Food Administration Re: Rule Method and Criteria for Approving the Ethics Committee for Considering the Clinic Trial Project in Relation to Drugs, dated 10 September 2018.

9 Ministerial Regulation No. 26 (B.E. 2537 (1994)) issued under the Drug Act B.E. 2510 (1967).

10 Section 79 of the Drug Act B.E. 2510 (1967).

11 Clause 8 of the Notification of Ministry of Public Health Re: the Online Submission of Pharmacopoeia Registration B.E. 2558 (2015).

12 Notification of the Food and Drug Administration Re: the Criteria on the Risk-Based Approach Safety Monitoring Program B.E. 2560 (2017).

13 Section 6 of the Medical Device Act B.E. 2551 (2008).

14 ibid.

15 Section 15 of the Trade Secrets Act B.E. 2545 (2002).

16 Clause 3 of the Rule of the Ministry of Public Health Re; the Keeping of Trade Secrets of Pharmacopoeia Registration Information B.E. 2550 (2007).

17 Clauses 18 and 19 of the Rule of Ministry of Public Health Re: the Keeping of Trade Secrets of Pharmacopoeia Registration Information B.E. 2550 (2007).

18 Ministerial Regulation Re: Modern Pharmaceutical Manufacturing B.E. 2546 (2003) and Notification of the Ministry of Public Health Re: Good Manufacturing Practice Requirements for Modern Medicines and Amendments of Good manufacturing Practice Requirements for Traditional Medicines in accordance with the Drug Act B.E. 2559 (2016).

19 Ministerial Regulation No. 20 (B.E. 2525) (1982), issued under the Drug Act B.E. 2510 (1967).

20 Section 41 of the Medical Device Act B.E. 2551 (2008).

21 ibid.

22 Section 12 of the Drug Act B.E. 2510 (1967).

23 Thai Government, 'Application for Obtaining License to Manufacture Modern Drugs' and 'The Application for the Consideration of Floor Plan of the Modern Drug Manufacturing Facility and Traditional Drug Manufacturing Facility' – http://www.fda.moph.go.th/sites/drug/SitePages/Zone_manual.aspx?Name=%E0%B%A2%E0%B8%B2 assessed 10 December 2019.

24 Section 20 of the Drug Act B.E. 2510 (1967).

25 Section 15 of the Medical Device Act B.E. 2551 (2008).

26 Section 17 of the Medical Device Act B.E. 2551 (2008).

27 Chapter 7 of the Medical Device Act B.E. 2551 (2008) and Chapter 11 of the Drug Act B.E. 2510 (1967).

28 Section 88 bis of the Drug Act B.E. 2510 (1967), and Section 57 of the Medical Device Act, B.E. 2551 (2008).

29 Section 57 of the Medical Device Act B.E. 2551 (2008).

30 Section 88 of the Drug Act B.E. 2510 (1967), and Section 59 of the Medical Device Act B.E. 2551 (2008).

31 Rules of the Food and Drug Administration Re: Rules on Advertisement of Drugs B.E. 2545 (2002).

32 Notification of the Food and Drug Administration Re: Rules Procedures and Conditions on Advertisement of Medical Device B.E. 2553 (2010).

33 Section 12 of the Drug Act B.E. 2510 (1967).

34 Section 6 and Section 24 Paragraph 2 of the Medical Device Act B.E. 2551 (2008).

35 Section 4 of the Drug Act B.E. 2510 (1967).

36 Section 76 and Section 78 of the Drug Act B.E. 2510 (1967).

37 Section 6 of the Medical Device Act B.E. 2551 (2008).

38 Food and Drug Administration, 'The Application for Export of Medical Device Certificate', p. 1.

39 Order of Narcotics Control Division No. 4/2562 Re: Determination of Duties and Power of the Narcotics Controls Division.

40 Section 15 of the Narcotics Act B.E. 2522 (1979).

41 '10 Things in Health Security' by National Health Security Office.

42 Public Procurement and Management of Supplies Act B.E. 2560 (2017).

43 Ministerial Regulation re: Public Procurement and Management of Supplies B.E. 2560 (2017).

44 Article 30 of the Ministry Regulation re: Public Procurement and Management of Supplies B.E. 2560 (2017).

45 Article 31 of the Ministry Regulation re: Public Procurement and Management of Supplies B.E. 2560 (2017).

46 Article 32 of the Ministry Regulation re: Public Procurement and Management of Supplies B.E. 2560 (2017).

47 Section 55(2) of the Public Procurement and Management of Supplies Act B.E. 2560 (2017).

48 Section 55(3) of the Public Procurement and Management of Supplies Act, B.E. 2560 (2017).

49 The most urgent letter of the committee on analysing the problems on Public Procurement and Management of Supplies the Comptroller General's Department No. GorKor. (GorWorJor) 0405.2/Wor 119 dated 12 March 2019.

50 Clause 3.1.1 of the Most Urgent Letter of the Committee on analysing the problems on Public Procurement and Management of Supplies the Comptroller General's Department No. GorKor. (GorWorJor) 0405.2/Wor 119 dated 12 March 2019.