**5. Pharmacovigilance regulatory framework of Thailand**

Thailand's pharmacovigilance system was developed in 1983. The Food and Drug Administration founded the national centre, which has a primary focus on the ADR monitoring programme. Starting with 176 total reports from many tertiary hospitals in the first year, the number of reports has grown to more than 50,000 each year, with pharmacists serving as the primary reporter. Consumers, market authorization holders and health services, such as drug stores, physician offices, private hospitals and all types of public hospitals, ranging from community hospitals to tertiary hospitals to academic and research hospitals, are also included in the field of work.

Together with other Asian nations, United States Agency for International Development (USAID) has taken the initiative to assess the pharmacovigilance mechanism in Thailand. The project's knowledge and learning experiences support not only the countries being examined, but they can also provide a base and principles for other countries' pharmacovigilance systems. Pharmacovigilance activities laws are as follows:


The name of the regulatory authority/website is the Thai Food and Drug Administration (www.fda.moph.go.th).

Thailand has officially joined the WHO programme (1984). For ICSR documentation, it uses the E2B compliance INTDIS format. WHO-ART (Adverse Reaction Terminology) was used for ADR terminology, ATC code for medication and ICD-10 for indication in medical terminology.

The type of reports in the PV database are as follows:


The reporting odd ratio (ROR), which has been in use since 2006, is one of the quantitative methods used in signal generation.

Thailand has the provision of keeping the responsible person to submit reports according to drug categories


Adverse drug event reporting systems in Thailand are as follows:



#### **Table 3.**

*The following are the timeframes needed to be followed by industries for Adverse Drug Reporting.*
