Responsibilities

The roles of the T&PAD are to

Establish and coordinate plans according to ministerial guidelines, oversee and evaluate the operations performed by other divisions under the Thai Food and Drug Administration
Acquire, store, and effectively utilize the information available in the agency, and be the information focal point of the FDA
Coordinate with foreign agencies in relation to health and medical issues, arrange meetings and international conferences as assigned
Monitor and improve the monitoring system about untoward effects from the consumption of health-products
Improve national chemical safety measures, and be the central agency for international cooperation in this area
Be the academic center for consumer protection in the field of health products, as well as an information provider according to the Information Law
Support and work together with officials from other relevant agencies as required.

Policy and Planning

Development of policy, and the strategic and action plans for the FDA are major tasks of this division. In accordance with the new restructuring of the Ministry of Public Health into clusters, the TPD plays an important role in initiating the corporate plan with other departments. This needs significant collaboration to consolidate the integrated plan for ensuring its effective implementation.

Examples of FDA policies and plans formulated by TPD are:

Policy on Strengthening of Health Product Protection ? Policy on Consumer Health Protection Program Research
The National Food Safety Strategic Plan
Human Resource Development Master Plan, and
FDA Budget Plan.

In addition, TPD makes situation analyses and policy recommendations in order to improve FDA performance.

Monitoring and Evaluation

Monitoring of the FDA’s performance has been continuously conducted so that the implementation of plans and projects has conformed to policy, strategy and objectives.

TPD is also responsible for improvement of the monitoring and control system for obtaining and evaluating strategies of the consumer health protection plan, including analyzing and evaluating its progress and outcomes.

Each year many activities at the FDA are carried out to assure consumer safety, and a great deal of effort and finance are expended. It’s TPD’s responsibility to oversee and assess the operational performance of the FDA in order to help develop and improve strategy formulation and planning.
Surveys and studies, such as the survey on Thailand’s Consumer Health Protection Situation, have been periodically conducted. Other documents such as the annual report, and information and statistics on consumer health protection, are regularly disseminated to all divisions and appropriate officers both at the center and in the provinces.

The FDA’s management system is intermittently evaluated, and attitude surveys of FDA personnel and of private sector contacts are conducted in order to determine levels of satisfaction.

Technical Development and Foreign Affairs

Human resources development is regarded as a key element of TPD’s responsibility and organizational development program. The Personnel Capacity Building Master Plan has been initiated and integrated into the FDA master plan. This includes the knowledge management program, and the study program in indispensable areas.

Training programs are also regularly run for the purpose of increasing the knowledge and skills of officers in working effectively and efficiently: training on research methodology and sampling techniques, English proficiency; team building management; and leadership are amongst the many topics. Participation in international training programs is also necessary for FDA personnel to keep up with the advances of science, technology and product development. Staff also attend national and international symposia.

Concern with foreign affairs is currently increasing and has become more important to the FDA’s activities. International cooperation and collaboration are major global concerns, either bilateral or multilateral relationships, especially in the area of free trade. Such relationships introduce a large number of cooperative programs. TPD serves as a focal point in foreign affairs, including negotiating in bilateral and multilateral meetings. TPD also occasionally makes arrangements and training programs for overseas visitors on request.

Additionally, collaborative projects have been conducted with other sources of funding or cooperation, such as the Department of Technical and Economic Cooperation; other international organizations, FAO, WHO, JICA; and some countries such as Australia, Canada, China, and USA. The purpose of all these relationships is the enhancement of the FDA’s performance and the development of its personnel.

Health Products Safety Development

The FDA’s principal responsibility is to protect consumers from hazardous chemicals or products. TPD pays more attention to prevention and closely monitors products that may cause adverse effects.

In relation to this priority, the Adverse Product Reaction Monitoring Center (APRMC) has been set up. The center is mainly responsible for the collection and interpretation of reports of adverse events from health products. Such reports are made voluntarily by professionals, officials or healthcare personnel when they
become aware of harm caused to a consumer. Formerly concerned solely with adverse drug reactions (a major worldwide concern), the Center’s responsibilities have been considerably widened to include many of the products under the FDA’s remit.

At the international level, the Center collaborates with the WHO Programme for International Drug Monitoring (pharmacovigilence) and the activities of its more than seventy member countries. At the national level, the network of hospitals across the country transfers reports to the APRMC. The center also regularly disseminates reports and provides feedback to health personnel on adverse effects data.

Studies on the evidence of well-known and new adverse effects have been conducted including investigations of rare and severe adverse effects, incidence of adverse effects and related causes such as genetics, gender, age, drug interaction, and misuse of drugs.

Chemical Safety

The responsibilities of the Chemical Safety Section are principally to serve as a national focal point for IFCS (Intergovernmental Forum on Chemical Safety) and IPCS (International Programme on Chemical Safety), to improve national chemical safety measures and to serve as the principal agency for international and national cooperation on these issues. The Chemical Safety Section works under the National Coordinating Committee on Chemical Safety (NCCS) which was appointed by the Cabinet as the national coordinating body. The committee is composed of high-level representatives of all concerned governmental agencies and NGOs, chaired by Public Health Minister with the FDA serving as the secretariat. The body then sets up cooperation among participating agencies and develops the National Master Plan on Chemical Safety (NMP).

The major task is to develop the NMP, including the Action and Budget Plans under the Master Plan. At the time of publishing this document, the first NMP (1997-2001) and 2nd NMP (2002-2006) have been endorsed by the cabinet (1997 and 2001, respectively), and translated into action by all relevant organizations. The third NMP (2006-2015) is being formulated, targeted for submission to the cabinet for endorsement by October 2005.

In addition, many other areas of activity have been launched: the national poison center network; the National Chemicals Management Profile; a chemical safety newsletter and guidebook; the dissemination of chemical safety information to concerned organizations in Thailand, the public, and other countries. (The electronic files for these can be found on the FDA website: www.fda.moph.go.th/ipcs) Research/analyses and criteria development for the risk management of chemicals are regularly conducted.

Apart from this, the Section also takes action and participates in international collaborations and forums: WHO/SEARO, IPCS and the Canadian Center of Occupational Health and Safety (CCOHS) in running an IPCS/INTOX workshop. Last but not least, Chulabhorn Research Institute and the Ministry of Public Health, Chemical Safety Section, on behalf of the Thai Government, organized the IFCS Forum IV, at the United Nations Conference Center, Bangkok in November 2003. The Forum was an event significant enough to move global chemical safety forward.

Library and Information Services

TPD’s library and Information Services include technical information about consumer protection in the field of health products and legislation, as well as journals, texts, research papers, magazines, and newspapers. FDA employees and the public are welcome to used the library and information services.

In addition, the library has developed an online technical database of health products as an evidence-base for research. There is also a Data Warehouse that is a repository of integrated information from heterogeneous sources, as it is generated, available for queries and analysis. This makes it much easier and more efficient to run queries over data that originally came from different sources. Visitors can access the library’s Webpages directly at www.fda.moph.go.th/lib.

The library also serves as an e-knowledge center and the FDA’s information center under the Official Information Act, B.E., 2540 (1997) so as to provide information in line with the provisions of the Act.