" Your Perfect Support for Life Sciences Business in Thailand"

Drug Development

In the process of drug development, it is very important to ensure the effectiveness and safety of products before they reach the consumers. To facilitate this, TCELS is constantly engaged in projects that support infrastructure development for pre-clinical testing and clinical research. TCELS also promotes regulatory compliance. Thai Pharmaceutical Manufacturers Association (TPMA) is a key collaborator of TCELS.

 

1. Pre-clinical Testing

For pre-clinical testing of drugs TCELS supports Health Products Safety Testing Center. Pharmaceutical products, food supplements, vaccines and cosmetics are tested for effectiveness and safety. Laboratory Animal Breeding Center ensures an adequate supply of laboratory animals to the Health Products Safety Testing Center. Quality control on these laboratory animals is guaranteed by the Laboratory Animal Monitoring Center.

a. Health Products Safety Testing Center

This center is a crucial step towards the advancement of pre-clinical research in the entire chain of health products. This toxicology testing laboratory complies with the international toxicology standards for pharmacopeias and other products registered in the Organization for Economic Co-operation and Development (OECD) Good Laboratory Practice (GLP), such as vaccines, herbal medicines, cosmetics and household chemicals. Testing for GLP compliance pertaining to immunogenicity, potency and the efficiency of vaccines and drugs helps our clients in reducing non-tariff barriers for international trade. 

b. Laboratory Animal Breeding Center

This center has been set up in collaboration with Mahidol University and breeds animals that meet international testing standards. Laboratory animals from this center are supplied to Health Products Safety Testing Center. This Laboratory Animal Breeding Center also trains experts in laboratory animal science. The project duration was from 2005 to 2007 and the center has now obtained the standards of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

c. Laboratory Animal Monitoring Center

It guarantees quality control for animal production in Thailand and is consistent with international standards ISO/IEC 17025. This center allows Thailand to improve the capacity and quality of its own breeding and testing units. It also equips Thailand to offer consultancy services to other laboratories in the region.

The establishment of these three centers supports the transfer of testing and production activities for pharmaceutical products, food supplements, vaccines and cosmetics from the United States and Europe to Asia. It further establishes Thailand as the hub of health sciences in Asia.

 

2. Clinical Research

TCELS is constantly striving for innovation and excellence. One of its objectives is to facilitate and advance high-quality clinical research. TCELS provides the necessary links between Contract Research Organizations (CRO) within and outside Thailand. It also networks investigators and researchers.

TCELS has initiated Multi Center Institutional Review Boards (IRBs) in most medical schools and research centers and has upgraded the Clinical Research Site to standardize and streamline all clinical research and trials. TCELS also supports the Medical Research Network (MedResNet) to manage the Thai Clinical Trial Registry (TCTR) system.

Companies who wish to register clinical trials in TCTR system are obliged to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (WHO-ICTRP) dataset. TCTR also aims to be a research database for clinical researches in Thailand. We welcome the registration of all kinds of clinical researches including clinical trials and observational studies. According to Clinical Trial Magnifier, April 2011, Thailand ranked seventh in Asia in terms of the number of trials conducted.

Thailand offers unique opportunity for researchers focusing on tropical diseases such as dengue, malaria, SARS, diarrhea, avian flu and Japanese encephalitis. Research opportunities in Thailand also include therapeutic areas such as respiratory, cardiovascular, endocrinology, dermatology, oncology and infectious diseases such as HIV and hepatitis virus infection. A growing clinical development sector is providing many opportunities to participate in clinical trials. Thailand has a large subject population and a pool of experienced investigators.

Data Management Centers in Thailand follow 21 CFR Part 11, which declares that the computer systems used in a regulated data management environment must be validated depending upon user’s requirements in specific working environment. The aim of the validation is to maintain accuracy, reliability, availability and authenticity of the required records and signatures. A number of sites have also implemented electronic Case Report Forms (CRFs).

In the emerging biopharmaceutical industry of Thailand, high priority will be given to research and development and clinical trials. TCELS will play a significant role of coordinating and networking these efforts.

 

3. Regulatory Compliance

To encourage regulatory compliance, TCELS has supported the establishment of an OECD GLP Accreditation Unit in Thailand for medical laboratories and public health. It supports the training of experts and encourages domestic laboratories to register for OECD GLP Certification. This project also engenders coordination of national and international organizations to apply for membership with OECD GLP international certifying organization. They are also encouraged to participate in activities and events as per the requirements of OECD GLP Technical Working Group. Establishment of this OECD GLP Accreditation Unit will bring Thailand another step closer to becoming an OECD country by the year 2015.

 

01-November-2013