The domestic pharmaceutical market in Thailand is anticipated to see a 4.5-5.0% growth in 2022 compared to the previous year. The easing of COVID-19 concerns and the recovery of the Thai economy have played a significant role in driving this growth. As the economy strengthens, patients are regaining confidence and seeking healthcare services, resulting in a higher demand for medicines and medical supplies.
Additionally, the reopening of the country to foreign visitors, particularly in tourist areas, has further bolstered the demand for pharmaceutical products. Looking ahead, the market is expected to continue growing from 2023 to 2025 due to multiple factors, including the increasing incidence of chronic non-communicable diseases (NCDs), the expansion of universal health coverage to cover the entire Thai population, a rise in the number of foreign patients seeking treatment in Thai hospitals, and a growing global focus on wellness and preventative healthcare that is influencing Thai consumers.
The Thai Food and Drug Administration (TFDA):
The Thai Food and Drug Administration (TFDA), also known as the Thai FDA, is responsible for regulating a wide range of products in Thailand, including pharmaceuticals, medical devices, food, cosmetics, and more. As a regulatory authority under the Ministry of Public Health, the TFDA plays a crucial role in safeguarding public health by implementing and enforcing stringent regulations specifically for pharmaceuticals.
Legal Representation:
When foreign pharmaceutical companies want to register their products in Thailand, they are required to appoint a local representative or a Thai-based company to act as their legal representative. This appointed representative assumes the important responsibility of communicating with the TFDA and ensuring that the foreign company meets all regulatory requirements in Thailand.
They serve as a bridge between the foreign company and the TFDA, facilitating the registration process and ensuring compliance with the necessary regulations. This enables foreign pharmaceutical companies to effectively market and distribute their products in the Thai market while adhering to the regulatory framework set by the TFDA.
Product Classification:
In Thailand, pharmaceutical products are categorized into three groups based on their risk levels and intended use.
1. Over-the-Counter (OTC) Drugs: These are medications that can be purchased without a prescription and are commonly used for self-treatment. Examples include paracetamol for pain relief, antacids for digestion, and cough syrups.
2. Prescription Drugs: Prescription medications, on the other hand, require a doctor's prescription for dispensing. They are typically more potent and carry higher risks due to their specific indications and potential side effects. Examples include antibiotics for bacterial infections and antidepressants for mental health conditions.
3. Traditional and Complementary Medicines: This category encompasses herbal medicines and traditional remedies with a history of use in Thai culture. They go through a separate regulatory process that acknowledges their traditional usage and limited risk profile. An example of such medicine is herbal capsules for digestive health.
Labeling Requirements:
In Thailand, pharmaceutical products must have labels written in Thai and include important information like product names, active ingredients, dosage forms, strength, usage instructions, warnings, and storage conditions. These labels follow the guidelines provided by the TFDA to guarantee clarity and accuracy for consumers.
Clinical Trial Requirements:
Before pharmaceutical products can be registered, clinical trials are commonly conducted to verify their safety and effectiveness. In Thailand, these trials follow international standards and the resulting data is evaluated by the TFDA.
Testing Requirements:
Testing is an integral part of ensuring the quality and safety of pharmaceutical products. Pharmaceutical companies conduct comprehensive and stringent tests to evaluate various aspects such as stability, purity, potency, and bioequivalence, among others. These tests are performed in accordance with the guidelines set by Good Laboratory Practice (GLP), which ensures that the testing procedures adhere to the highest standards and produce accurate and reliable results. By complying with these standards, pharmaceutical companies can confidently deliver products that meet the strictest quality and safety requirements.
Foreign Testing:
The TFDA, under certain circumstances, may accept foreign testing data for product registration. However, for acceptance, the data must meet the required standards and must be conducted in countries that have regulatory systems recognized by the TFDA.
Pre-registration Requirements:
Foreign companies are required to submit pre-registration documents, including a letter appointing a local representative, a product sample, and a letter certifying compliance with Good Manufacturing Practice (GMP) standards, before moving forward with the registration process.
Registration Process:
Document Submission: Companies submit essential documentation, including product information, quality data, clinical trial results, and labeling.
Review and Evaluation: The TFDA carefully assesses the submitted documents for their completeness and compliance with regulations.
Inspection: The manufacturing facility may undergo an inspection to ensure compliance with GMP standards.
Approval: If the application meets the TFDA's satisfaction, the product receives approval for marketing in Thailand.
This process comprises multiple stages and is known for its time-consuming nature. However, it is crucial to ensure regulatory compliance and quality standards for product marketing in Thailand.
Recognition of EU/US Approvals:
In order to streamline the registration process in Thailand, it can be advantageous to secure approval for a product in the European Union (EU) or the United States (US). The Thailand Food and Drug Administration (TFDA) views approval in these well-regulated markets as a strong indication of the product's safety and effectiveness. This recognition from the TFDA can significantly expedite the registration process in Thailand, as it demonstrates that the product has already met stringent regulatory standards. By leveraging international approvals, companies can save time and enhance their product's credibility, ultimately facilitating a smoother registration process in Thailand.
Import and Distribution Requirements:
Once a pharmaceutical product is registered in Thailand, the next step is to initiate the importing and distribution process. To proceed, companies need to acquire an import license from the Thailand Food and Drug Administration (TFDA) and adhere to distribution guidelines for the correct handling and storage of the products.
List of Documents Required:
The documents required for each module of the registration process may vary depending on the type of product. However, a typical registration dossier may include:
Product information and labeling
Quality control and manufacturing details
Preclinical and clinical study data
Stability testing data
Bioequivalence or bioavailability study results
GMP compliance certificate
Pharmacovigilance plan
Risk management plan
Import and distribution license
GMP Inspection Requirements:
During the registration process, the TFDA may conduct GMP inspections of the manufacturing facilities to verify compliance with global quality standards.
Timeline:
The timeline for pharmaceutical product registration in Thailand varies based on product complexity and documentation completeness, typically spanning 6 months to 2 years on average.
Associated Fees:
The fees for various licenses and evaluations in the pharmaceutical industry are as follows:
(1) Modern Drug Manufacturing Licenses: THB 8,500 per license.
(3) Modern Drug Selling Licenses (Wholesale): THB 2,000 per license.
(4) Modern Drugs Import License: THB 38,000-88,000 per license.
(5) Technical Document Evaluation for New Drug Registration: THB 155,000 – 395,000 per product.
Post-Marketing Activities:
After a pharmaceutical product is approved and launched in the market, companies need to comply with post-marketing activities. These activities include pharmacovigilance to monitor and report adverse drug reactions. Companies may also need to apply for variations to the product registration, such as changes to the dosage form or strength. Additionally, periodic renewal of the product registration is required by the TFDA. Compliance audits may also be conducted to ensure ongoing adherence to regulations.
Conclusion:
Successfully navigating the pharmaceutical regulations in Thailand requires careful planning, thorough documentation, and adherence to TFDA guidelines. By understanding the regulatory process and fulfilling all requirements, pharmaceutical companies can successfully register their products and enter the thriving pharmaceutical market of Thailand.
References:
Thai Food and Drug Administration (TFDA): https://www.fda.moph.go.th/eng/index.stm
Thailand: Regulatory Authority and Requirements for Approval of Medicinal Products: https://www.aseanbriefing.com/news/thailand-regulatory-authority-requirements-approval-medicinal-products/
Guidelines on Drug Registration in Thailand: https://www.fda.moph.go.th/eng/documents/Guideline_on_Drug_Registration_in_Thailand_2016.pdf
Thailand - Regulatory Overview: https://www.ema.europa.eu/en/documents/other/thailand-regulatory-overview-ema-infographic_en.pdf
ASEAN Common Technical Requirements (ACTR) for Registration of Pharmaceutical Products: https://asean.org/storage/2017/06/3.-Indonesia-Guidelines-for-Good-Clinical-Practice-for-Clinical-Trial.pdf
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