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Dr. Siriwat Tiptaradol
Food and Drug Administration
Thailand

The Problem

The current mission of the Thai Food and Drug Administration (FDA) is to supervise all health products before and after being launched in the market as well as to control license applications in order to ensure that the health products are of good consistent quality, standard, and safety. However, the various application procedures for each health product approval were inconvenient and slow for a person or organization requesting such approval from the Thai FDA. The process of licensing was both slow and costly for both customers and the Thai FDA. Economic development has also meant increased business for the Thai FDA without commensurate increases in funding or manpower, placing a critical strain on its ability to serve the public.

More information is available on the website of the One Stop Service Center (Food and Drug Administration Ministry of Public Health Thailand):
http://newsser.fda.moph.go.th/ossc/eng/frontend/index.php

Solution and Key Benefits

 What is the initiative about? (the solution)
The Thai Food and Drug Administration established the One Stop Service Center to facilitate services to everyone who needs to file documents related to health products with the Thai FDA. The Thai FDA has developed and improved its working systems, reducing steps and time as a result of the dissemination of authority, improvement of rules and orders, use of information technology, improvement of facilities and training of personnel.
One Stop Service Center (OSSC), a service providing unit of Food and Drug Administration, has improved and developed its service efficiency in the following aspects.

1. Introduces a new concept: OSSC has integrated services scattering in five divisions which are 1) Drug Control Division providing permission for drug, 2) Food Control Division providing permission for food, 3) Medical Devices Control Division providing permission for medical devices, 4) Cosmetics Control Group providing permission for cosmetics, and 5) Hazardous Substances Control Group providing permission for hazardous substances. Every abovementioned products can be permitted in one stop at OSSC.
2. Promotes accountability: OSSC applied information technology in order to manage the Center by collecting and examining every in-charge person who records data, considers, and grants permission.
3. Promotes equity: The applicant who arrives at OSSC will be granted an equal right on filing the application. The applicant must pick up a queuing card, regardless of products and the service will be provided in sequence.
4. Promotes responsiveness: The officers at OSSC shall provide the same standard by following “7 Service Standards” .

1. Be smiley, cheerful, and willing to provide service
2. Correct and update data
3. Every application must be responded within the specific time.
4. The director of concerned division can be contacted.
5. Concerned health products must comply with the specified law.
6. Listen to the opinion of service users.
7. Every opinion must be considered.
5. Promotes transparency: OSSC held a training program on consideration of health products to be in the same direction. The obtained data on product consideration are posted on Internet. With this regard, operators can examine by themselves on which type of products is before submitting the application. In addition, OSSC has announced 208 procedures of services. Therefore, the applicant can check how many days the application is approved.
6. Transforms administration: OSSC has applied the new management method. The academics officers will be rotated from the officers of product division/group in order to serve the visitors of OSSC. Details of each products shall comply with the law of each product division/group.
A performance evaluation found that 80% of customers are now satisfied with the initiative. Furthermore, the Thai FDA has organized a procedure for customers to make comments in order to gather information for continuous service improvement, implementing a questionnaire to collect comments. A complaints box has been placed in the center for customers to send their comments which will be collected to implement improvements to increase service efficiency. Moreover the complainant can also send e-mail directly to the Director.

Actors and Stakeholders

 Who proposed the solution, who implemented it and who were the stakeholders?
In accordance with the Thai Bureaucratic Strategic Development Plan (2004-2007) and the Royal Decree regarding Criteria and Administration of Good Governance (2004), the Thai government adopted a public reform policy. Under this policy the public sector has to adjust its working procedures and methods to provide the most efficient and productive service to consumers. In this regard, the Thai Food and Drug Administration (Drug Control Division, Food Control Division, Narcotic Control Division, Medical Devices Control Division, Cosmetic Control Group and Hazardous Substances Control Group) has developed its working system in various ways, for example, services improvement, step and time reduction and rules and orders amendment to correspond with the evolving current situation. One such development was the establishment of the One Stop Service Center to provide services relating to health products (excluding psychotropic substances and narcotics). This implementation supports transparency and fairness in serving business operators and citizens who require information.
More information is available on the website of the One Stop Service Center (Food and Drug Administration Ministry of Public Health Thailand):
http://newsser.fda.moph.go.th/ossc/eng/frontend/index.php

(a) Strategies

 Describe how and when the initiative was implemented by answering these questions
 a.      What were the strategies used to implement the initiative? In no more than 500 words, provide a summary of the main objectives and strategies of the initiative, how they were established and by whom.
1. Development, improvement and amendment of rules and orders to correspond with the evolving current situation and criteria for transparency as well as to provide fairness to both customers and consumers.
2. Authorizing officers are now empowered to approve certain files for rapid processing.
3. Development of rapid services by reducing the steps and time for 64 application procedures to enable them to be processed in one day.
4. Production of 65 application manuals in simple language which is easy to understand.
5. Introduction of information technology into the working system, for example, automatic queue tickets, downloadable application forms and e-submission of application forms.
6. Establishment of standard operating procedures to ensure that all officers perform to the same standards such as policy handbooks covering health products, how to operate procedures and criteria to consider relative to each product
More information is available on the website of the One Stop Service Center (Food and Drug Administration Ministry of Public Health Thailand):
http://newsser.fda.moph.go.th/ossc/eng/frontend/index.php

(b) Implementation

 b.      What were the key development and implementation steps and the chronology? No more than 500 words
The Thai Food and Drug Administration established the One Stop Service Center to facilitate all applicants who need to file documents related to health products with the Thai FDA. The Thai FDA has developed and improved its working systems, for example, reduction of steps and time, dissemination of authority, improvement of rules and orders, use of information technology, improvement of facilities and training of personnel. A performance evaluation found that 80% of customers are now satisfied with the improved services. Furthermore, the Thai FDA has organized a procedure for customers to make comments in order to gather information for continuous service improvement.
Activity Duration
1. Project drafting October 2003
2. Budget proposal December 2003
3.Preparation of working system improvement January - November 2004
4. Training of personnel in services and use of automatic queue tickets June - November 2004
5. Building construction June - November 2004
6. Services trial November 2004
7. Official opening December 2004
8. Continuous service improvement
with e-tracking on a website to find out if an application is approved / not approved by authorities
December 2004 - Present
9. Development of logistics to facilitate services October 2006 - Present

Conclusion
1. Customers are satisfied at the improved and streamlined procedures.
2. There are many of requests for study visits from both domestic and overseas agencies.
3. An average of 300-400 customers per day now use the services.
4. The Thai FDA extended these improvements to every province of the country by September 2006.
5. More efficient working systems by using e-tracking on a website
More information is available on the website of the One Stop Service Center (Food and Drug Administration Ministry of Public Health Thailand):
http://newsser.fda.moph.go.th/ossc/eng/frontend/index.php

(c) Overcoming Obstacles

 c.      What were the main obstacles encountered? How were they overcome? No more than 500 words
According to user feedback, after opening the One Stop Service Center at the Food and Drug Administration, the main obstacles to its effectiveness were:
1. The deficit number of consulting staff for the registration process;
2. A rigid health product registration process that requires proprietary information on ingredients and flavorings;
3. Excessive documentation and certification requirements;
4. Restrictive health product standards for the use of biotechnology products, food additives, coloring and flavorings;
5. Proposed regulations for “health” certification that provided no scientific information to justify the selection of these products nor any nutrient criteria for the designation.
From the development of services and the reduction of complaints mentioned above, the Thai FDA can monitor health products in the market place more closely, especially products that impact health, for example, new drugs or new technology health products, to prevent hazardous products from reaching consumers.
As a result of the above feedback, to improve the level of user satisfaction with the service, we must ensure service standards and the quality of health products by continuously improving as follows:
1. Increasing the facilities at the One Stop Service Center by providing television, air conditioning, a coffee café shop and other facilities to increase user comfort;
2. Reducing procedures and increasing flexibility;
3. Improving the Fast Track line;
4. Adding more channels for Q & A to obtain a permit through E-tracking;
5. Adding more channels for requests and/or complaints about health products at the One Stop Service Center;
6. Adding more service networks by expanding the One Stop Service Center to the other 75 provinces.
More information is available on the website of the One Stop Service Center (Food and Drug Administration Ministry of Public Health Thailand):
http://newsser.fda.moph.go.th/ossc/eng/frontend/index.php

(d) Use of Resources

 d.      What resources were used for the initiative and what were its key benefits? In no more than 500 words, specify what were the financial, technical and human resources’ costs associated with this initiative. Describe how resources were mobilized
1.Budgeting
The Thai Food and Drug Administration included a proposal for the project in its 2004 budget. A total of $340,000 was approved $265,000 for building construction $75,000 for related facilities. The One Stop Service Center now has a budget and $75,000 annual operating.
2.Building and facilities
The facilities are on the first floor of the building of the Thai Food and Drug Administration and it has been designed and furnished to ensure an up-to-date office with full facilities.
3.Working system
The Thai FDA has improved its working system in order to increase service quality as follows:
1. Development, improvement and amendment of rules and orders to correspond with the evolving situation and criteria for transparency and fairness to both customers and consumers.
2. Authorizing officers are now empowered to enable them to approve files for rapid processing.
3. Development of rapid services by reducing the steps and time for 64 application procedures to enable them to be processed in one day.
4. Production of 65 application manuals in simple language which is easy to understand.
5. Introduction of information technology into the working system, for example, automatic queue tickets, downloadable application forms and e-submission of application forms.
6. Establishment of standard operating procedures to ensure the all officers perform to the same Standards
4. Personnel
1. Development of personnel regarding the potency and efficacy of services for each product type with rapid and precise services and staff rotation.
2. Training of personnel to be service oriented and provide a consistently high level of service to all applicants
More information is available on the website of the One Stop Service Center (Food and Drug Administration Ministry of Public Health Thailand):
http://newsser.fda.moph.go.th/ossc/eng/frontend/index.php

Sustainability and Transferability

  Is the initiative sustainable and transferable?
1. The internal structure of the Thai FDA has been modified to support the management of the One Stop Service Center through its inclusion in budget plans and proposals.
2. There are performance evaluations to ensure a high level of implementation and continuous development.
3. Staff rotation has been introduced to maintain service standards and to develop improved working systems.
4. The initiative has been implemented in principle and is now in every province, expanding the concept of the One Stop Service Center to every province.
5. The infrastructure of the One Stop Service Center has been evaluated as sustainable and is under the direction of the Secretary General of the Thai FDA
More information is available on the website of the One Stop Service Center (Food and Drug Administration Ministry of Public Health Thailand):
http://newsser.fda.moph.go.th/ossc/eng/frontend/index.php

Lessons Learned

 What are the impact of your initiative and the lessons learned?
1. Providing satisfaction to people is a non-stop activity.
2.There must be an ongoing review and planning of service management of health products approval by reviewing working procedures on a regular basis.
3. Personnel development plans must be developed and implemented to support the working system reforms.
4. There must be construction of relevant buildings and facilities to support service points work flow.
5. There must be increasing use of technology and more channels to improve the way to submit applications.
6. Ample information must be on a website in the local language / an international language
7. To achieve sustainable development, There must be R&D and improvement of the quality control assurance system.
8. It is our duty to ensure a high level of satisfaction with our service.
More information is available on the website of the One Stop Service Center (Food and Drug Administration Ministry of Public Health Thailand):
http://newsser.fda.moph.go.th/ossc/eng/frontend/index.php

Contact Information

Institution Name:   Food and Drug Administration
Institution Type:   Government Agency  
Contact Person:   Mrs. Narupa Wongpiyarattanakul
Title:   Deputy Director  
Telephone/ Fax:   662 5907275
Institution's / Project's Website:   662 5918468
E-mail:   jeng@fda.moph.go.th  
Address:   One Stop Service Center
Postal Code:   11000
City:   Nonthaburi
State/Province:   Nonthaburi
Country:   Thailand

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