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Cooperation between Thailand and Lao PDR

 

The Government of the Kingdom of Thailand and the Government of the Lao People's Democratic Republic have signed a Memorandum of Understanding on Health Cooperation on September 16, 2016 and agreed with the Joint Action Plan during 2016 – 2017.

To Implement on the joint action plan, Thai Food and Drug Administration (FDA) has coordinated with the Food and Drug Administration (FDD) of the Lao People's Democratic Republic. The Lao-Thai bilateral meeting on the 3rd Lao PDR on 2-4 August 2018 was held in Lao PDR. 

The objective is to develop a joint action plan for 2018-2020 and discuss the implementation of the Joint Action Plan.

 

 

 

 

 

Prior to the Lao-Thai bilateral meeting on July 23, 2018 the Xepien-Xenamnoy Hydropower dam construction project has cracked in the dam; as a result, the mass of water flooded the area. Thousands of Lao people have been affected The Food and Drug Administration, Thailand considers that the flooding in the Lao People's Democratic Republic affects many Laos people and there is a need for medicines and supplies. The 500 medicinal herbs and supplies were distributed to the Food and Drug Administration of the Lao People's Democratic Republic to help flood victims. 

 

Cooperation between Thailand and Republic of the Union of Myanmar 

To continue strengthen the bilateral health cooperation in topic on Food and Drug Safety  between the Government of the Kingdom of Thailand and the Government of the Republic of the Union of Myanmar, the Food and Drug Administration, Ministry of Public Health, Thailand co-hosted with Department of Food and Drug Administration (DFDA), Ministry of Health and Sports, Myanmar held the bilateral meeting on Food and Drug Cooperation during 24-28 January, 2018 in Naypyitaw and Bagan, Republic of the Union of Myanmar to discuss the Joint Action Plan for the year 2018-2020. The results of the discussions conclude activities in the field of personnel development, such as Training on monitoring of imported health products, Training on capability of cosmetic regulators in the online notification process, Product Information File (PIF) audit, GMP and post-marketing  surveillance on cosmetics, Training on Drug GMP and computerized Information System, GMP Training for High and Medium Risk Food Production (Pasteurized Milk and Canned Food), Training for Medical Device Regulators to improve technical infrastructure, including exchange of health-related product safety information to address the situation of the two countries.

 

In addition, the delegates of the Food and Drug Administration also attended the 3rd Ministerial Meeting of the Thailand-Myanmar Health Collaboration during 23-24 August 2018 in Yangon, Republic of the Union of Myanmar. The meeting also discussed Food and Drug Cooperation. The outcome of the meeting was the extension of the existing cooperation plan to 2019-2021, with the addition of activities to suit the needs of the agency, integrating the cooperation on Food and Drug Checkpoint into the Health Service system Development for Migrant Workers and Cross-border Population, Component 3 “Strengthening Cross-border Collaboration” to achieve integrated work among relevant sectors, resulting in more efficient and tangible.

Cooperation between Thailand and The People's Republic of China

 

1. Background


        On January 18, 2007, the Ministry of Health of Thailand and the State Food and Drug Administration (SFDA) of the People's Republic of China signed a technical cooperation agreement, The Memorandum of Cooperation between the Ministry of Public Health and the State Food and Drug Administration.

2. Cooperation Issues


        1. Exchange law and regulation in English via website.
        2. Exchange personnel in control of Chinese traditional medicine, compulsory license and medical device.
        3. Provide simple procedure for drug testing using NIR technology.
        4. Develop human resources on medical device, biomaterial monitor and control, and quality control on traditional Chinese medicine.
        5. Create warning system on health product.
                5.1 Emergency alert system to force the health, safety and quality of the product after reaching the market
                5.2 Study trip to enable personnel to monitor the safety of drug uses

3. The Operations

        The FDA held the meeting of The 1st Joint Working Committee Meeting of the Ministry of Public Health of Thailand and the SFDA of the People's Republic of China during the period from 25 to 27 December 2007 to provide the Action Plans.  The two countries had conducted joint operation plans (Joint Action Plan) within two years, which covered the following six areas.
        1. Exchange rules and regulations on modern medicine, traditional medicine, and medical device.
        2. Exchange experts in medical law, modern medicine, traditional medicine, and medical device including the enforcement of medical patent.
        3. Cooperate in monitoring drug quality by simple testing procedure
        4. Develop vaccine.
        5. Develop modern and traditional Chinese medicine personnel.
        6. Regulate drug and quality assurance for traditional Chinese medicine.      

       

         Subsequently, on August 24-26, 2009 with The 2nd Meeting Joint Working Committee Meeting of the Ministry of Public Health of Thailand and SFDA of the People's Republic of China had held to enforce closer relationship between the two parties and to monitor the progress of plans for the year 2009.
       

         On June 15, 2011, FDA held a meeting with SFDA to summarize the operation and purposed further cooperation in the area of cosmetic. Through the exchange of cosmetic regulation via English website, study trip, personnel development, and personnel exchange program.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cooperation between Thailand and Japan
 
The Food and Drug Administration (Thai FDA) of Ministry of Public Health of the Kingdom of Thailand has cooperative academic activities with Pharmaceuticals and Medical Devices Agency (PMDA); the Japanese regulatory agency has the main role to review of drugs and medical devices in Japan. Thai Food and Drug Administration and Pharmaceuticals and Medical Devices Agency (PMDA), Japan have co-hosted the annual academic meeting Thailand – Japan Symposium as follows:
 
1. The 1st Thailand-Japan Symposium was held during the period from 24 to 25 October 2013 at the Ambassador Hotel, Bangkok. The objective of the symposium is to provide the Risk management plan, Pharmacovigilance, GMP Inspection and Pharmacopeia.
 
 
 
 
2. The 2nd Thailand-Japan Symposium was held during the period from 15 to 16 October 2014 at The Four Wings Hotel, Bangkok. The aim of this symposium is to continue to strengthen Thailand and Japan's mutual relationship and cooperative framework for pharmaceutical regulation and promote a thorough understanding of regulatory systems of New Drug Review, GMP Inspection and Pharmacovigilance of two host countries. 
 
 
 
3. The 3rd Thailand-Japan Symposium was held on March 24, 2016 at Hotel Windsor Suites & Convention, Bangkok. The aim of this symposium is to continue to strengthen Thailand and Japan's mutual relationship and cooperative framework for pharmaceutical regulation and promote a thorough understanding of regulatory systems, Drug registration, and e-Submission. Moreover, Medical devices topics as follows: Classification of medical devices and utilization of international standards in Japan : Especially for certification standards and approval standards, Definition and Classification of Medical Devices and List of Medical Devices in each medical devices class and AMDD in Thailand, Post-market Safety Measures for Medical Devices in Japan, Post-market surveillance and vigilance system in Thailand,  Quality Management System have been newly covered in addition to the session on pharmaceuticals. 
 
 
 
4. The 4th Thailand-Japan Symposium was held on February 2, 2017 at Holiday Inn Bangkok Sukhumvit, Bangkok. In this 4th Thailand-Japan Symposium, the two host countries are shared their latest information about the review in the session on pharmaceuticals, Pharmacopoeia, Pharmacovigilance, Supportive measure for industry, Capacity building for regulator and industry and topics in medical devices such as adverse Event / Device Defect & Field Safety Corrective Action Reporting Requirements and Implementation, Standards for Medical Devices, SaMD Software as Medical Device Control Requirement of GMP-MD in Japan and Control System on Advertisement of Medical Devices in Thailand.
 
 
5. The 5th Thailand-Japan Symposium was held on April 26, 2018 at Radisson Blu Plaza Bangkok.  In this Symposium, pharmaceutical topics are the Best Practices for Pharmaceutical Post-Market Surveillance which focused on high risk medical product and Antimicrobial medicines, GMP Inspection : building and strengthening GMP inspection of Regenerative Medicine, GDP and GSP in Japan, Pharmacovigilance and topics in Medical Devices such as Consultation for medical devices and SAKIGAKE system, High risk medical devices (non-IVD) Regulation, Global harmonized standard vs Local standard and Post – marketing Alert System.
 
 
PMDA also provides technical support for Food and Drug Administration’s (Thai FDA) staff members to attend training programs in Japan about topics on regulations of pharmaceutical, medical devices and consumer protection and PMDA continues to provide training on Drug registration system, GMP Inspection and Health Product Post-market surveillance including send PMDA staff members to educate the Thai FDA regulators as topics follows: Generics Track in Generic products, Quality, Japanese Pharmacopoeia, Pharmacokinetics Drug, Clinical and Safety and Medical Devices track on the supervision and Regulation of Medical Devices, evaluation of Orthopedic and dental medical device and Post-market safety measures for medical devices in Japan and the Japan International Cooperation Agency (JICA) also provides specialists to the Food and Drug Administration’s to advise Thai FDA staff on drugs review.
 
Moreover, the Bilateral Meeting will be organized annually between Food and Drug Administration and Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labour and Welfare from Japan to discuss topics related to the laws and regulations pertinent to medical products in Japan and the Kingdom of Thailand, and to consider possible cooperation aimed at sharing the best practices and regulatory updates on drugs and medical devices. On April 9, 2018 Secretary-General of Food and Drug Administration, Ministry of Public Health of the Kingdom of Thailand and Director General of Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare of Japan signed a technical cooperation agreement, the Memorandum of Cooperation on Medical Products Regulation Dialogue and Cooperation Framework, which was signed in Tokyo, Japan.
 
 

 

 

 

 

 

 

The implementation of the Food and Drug Administration to support the ASEAN integration

 

 

 

 

 

 

 

 

 

        The FDA is mainly responsible for product category working group under the ASEAN Consultative Committee on Standards and Quality (ACCSQ). To facilitate trade, regulation and law, ACCSQ committee has appointed the following five product working groups:

1. Pharmaceuticals Product Working Group (PPWG).

PPWG objectives are adjustment of rules and procedures of pharmaceutical products, supporting for drug registration, trade and cooperation in the region, and elimination of any Technical Barrier to Trade (TBT) among ASEAN members according to plan and schedule. FDA representative has also served as Co-Chairman in working group.

2. Traditional Medicines and Health Supplement Product Working Group (TMHSPWG)

TMHSPWG objectives are harmonization and implementation of rules, certification of traditional medicine and health supplement product among ASEAN members.  It also appoints sub-working groups to facilitate its goals, which are the ASEAN TMHS Scientific Committee (ATSC) and the Task force on TMHS GMP.

3. ASEAN Medical Device Committee (AMDC)


AMDC objectives are overall responsibility of coordinating, reviewing and monitoring the implementation of ASEAN Agreement on Medical  Device Directive (AMDD) and reduction of trade barriers due to regulatory and technical measures. At the same time, it can confidently protect consumers, to ensure the quality, efficiency and safety of medical devices.

4. Prepared Foodstuff Product Working Group (PFPWG)

PFPWG  aims to eliminate technical barriers to trade for prepared foodstuff products by:

     1. Exchange information regarding rules, procedures and regulations among member states.

     2. Review, analyze and compare the regulatory mechanisms between the member state

     3. Set up area of cooperation and mutual recognition (MRA), develop, implement, and monitor the joint Sectoral MRA.

     4. Establish technical infrastructure and ensure joint confidence in testing and evaluation for certification.

 

5. ASEAN Cosmetic Committee (ACC)


              ACC objectives are adjustment of  rules and regulations about cosmetic products in ASEAN, promotion and facilitation of trade, and making imports and exports faster. It has to correspond to the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRs).

              The essence of this agreement is to use the same standard regulations for cosmetic products in ASEAN.   By adapting the regulations, cosmetic entrepreneur must declare product details before sending out to the market. ASEAN member countries must implement the provisions of the ASEAN Cosmetic Directive since 1 January 2551 onwards. These regulations will reduce the pre-market monitor and emphasis in the post-market monitor instead. Thailand must enforce this new regulations and change related internal law and regulations. In addition, entrepreneur has to provide necessary information for the safety of cosmetic products and be ready to show them to the authority at its manufacturing location.