IBC泰國法律金融會計事務所International Business Consultancy

What You Should Know About Thai Food and Drug Administration

您應該知道的泰國食品藥物管理局

In our previous article “What You Should Know When Importing Food to Thailand” (https://0rz.tw/ZQwZj), we have mentioned that when an importer wishes to import foods and drugs to Thailand, the importer is required to obtain an import license from Thai Food and Drug Administration (“FDA”). In order to ensure its quality and efficacy of food products, the mission of the FDA is to inspect health product quality, safety, and effectiveness to protect public health in Thailand. Questions come to what are the roles and function of FDA in Thailand?

在我們先前的文章“您應該知道的進口食品到泰國須知” (https://0rz.tw/ZQwZj)有提到，當進口商想要進口食品以及藥品進泰國，需要從泰國食品藥物管理局(“FDA”)獲得進口許可證。FDA的使命是確保食品的質量和功效，檢查保健產品的質量、安全性和有效性，以保護泰國的公眾健康。到底FDA在泰國的角色跟目的是什麼?

According to the announcement issued by Thailand Ministry of Public Health title “The Division of Governance of Thailand Food and Drug Administration, 2020 A.D”, the FDA has 8 primary missions under the law as such:

根據泰國公共衛生部發布的標題為“2020泰國食品藥物管理局治理司”的公告，根據法律FDA有 8 項主要任務：

1. Enforcing the law regards to food, drug, cosmetic, dangerous chemical, psychotic-induced drugs, narcotics, medical instrument, law regards to the prevention and restriction of volatile material and other related law. 

      執行有關食品、藥品、化妝品、危險化學品、精神類藥物、麻醉品、醫療器械的法律，有關預防和限制揮發性物質的法律和其他相關法律。

2. Developing the procedure or mechanisms in regards to all laws under the FDA responsibility. 

     針對 FDA 負責的所有法律制定程序或機制。

3. Take precaution, issue guidance and quality controls of the product, advertisement agency, and undesirable side effects of the product. 

      對產品、廣告代理、產品不良副作用採取預防措施、發布指導和質量控制。

4. Research and analyze and develop the technology, knowledge, and procedure to protect the consumer in regards to the public health safety and benefits to the highest quality and efficacy.  

    研究、分析和開發技術、知識和程序，以保護消費者的公共健康安全以及最高質量和功效的利益。

5. Support consumers to be vested in the knowledge of the decision to choose the right product for the right circumstances, to acknowledge consumers of their right to complain and protect against the malicious products.  

    支持消費者了解在正確情況下選擇正確產品的決定，承認消費者有權投訴並防範惡意產品。

6. Developing and assisting in events where it is directly regarded to consumers’ health, consumers’ safety in both public and private events. 

      在公共和私人活動開發和協助直接關係到消費者健康、消費者安全的活動。

7. Developing the cooperation in international trade in regards to the public health and national’s benefits.  

     在公共衛生和國民利益方面發展國際貿易合作。   

8. Operates other necessary actions that is direct from the prime minister or the office of Prime Minister.  

      直接由總理或總理辦公室執行其他必要行動。

             
As such, the responsibility of the FDA can be simply summarized into five areas as:

FDA的責任可簡單摘要分成5個部分，為:

• Pre-marketing Control: control the manufacturing facility, product quality, and the advertisement before a product is officially sold to the market. 

      上市前控管:在產品正式上市前控管生產設施、產品質量和廣告。

• Post-marketing Control: investigate the product manufacture facility and product quality, and make sure they maintain the previous-approved standard.  

      上市後控管 ：調查產品製造設施和質量，並確保產品保持先前批准的標準。

• Surveillance Program for Consumers' Safety: The FDA will collect research and epidemiological data about any negative effect or any unexpected result when a product is being used by a consumer. After gathering the data, the FDA will summarize and report these data.

消費者安全監測計劃：當消費者使用產品時，FDA 將收集有關任何負面影響或任何意外結果的研究和流行病學數據。收集數據後，FDA將匯總並進行報告。

• Consumer Education: Make sure necessary and accurate information is provided to customers so they can select products wisely. The information can be provided by TV, radio, newspaper, and internet.

教育消費者：確保提供客戶必要和準確的資訊，以便他們明智地選擇產品。可藉由電視、廣播、報紙及網路提供必要資訊。

• Technical Support and Cooperation with other Agencies​: Participate in seminars and conferences to broaden the horizon. The Good Manufacturing Practice (GMP) program is an example to show cooperation with other organizations.

    技術支持和與其他機構的合作：參加研討會和會議以便拓寬視野。良好生產規範 (GMP)計畫是展示與其他組織合作的一個例子。

IBC International Business Consultancy is a law, finance, and accounting firm located in Bangkok, Thailand with experienced lawyers, accountants, and financial advisers. We provide services including investment, tax, and legal advice in Thailand. Should you have any questions, please do not hesitate to contact us via Line: @ibcfirm for further information.

IBC泰國法律金融會計事務所 (International Business Consultancy) 為一間位於曼谷的泰國法律金融會計事務所，由經驗豐富的律師、會計師、及財務顧問組成，可提供泰國投資、泰國稅收及泰國法律諮詢等服務。如果有什麼問題，可以隨時通過Line: @ibcfirm與我們聯繫。