2.1 Mandatory Reports

2.1.1 Human drugs, narcotics and medicinal psychotropic substances

Marketing authorization holders have the duty to report safety information of human drugs, narcotics and medicinal psychotropic substances. Safety information, in this case, means the reporting of adverse event resulting from the use of health product of an individual patient (Individual Case Safety Report: ICSR) and other safety information. For more information regarding reporting scope, minimum criteria for reporting, reporting timeframe, and report submission channels, please refer to “Guidance for Market Authorization Holders on Post-marketing Safety Reporting for Human Drugs, Narcotics, and Medicinal Neuropsychotropic Substances”.

Other post-market safety information monitored by the HPVC in accordance with its responsibility can be divided into 3 different types, the submission requirements of which are as follows:

1) Periodic Benefit-Risk Evaluation Report (PBRER) or Periodic Safety Update Report (PSUR), which shall be submitted by marketing authorization holders upon a request of the Thai Food and Drug Administration;

2) Risk Management Plan (RMP), which shall be submitted by marketing authorization holders upon a request of the Thai Food and Drug Administration;

3) Other safety information received by marketing authorization holders from either a research study or a relevant regulatory agency which could potentially affect the change of the current risk management measures, which shall be submitted to the HPVC as soon as possible.

The marketing authorization holder of a new drug, a new generic drug or a new biological product shall monitor the safety profile of the product in accordance with its risk level, which ranges from level 1-4 (level 1 as the highest risk). For more information regarding activities, forms, action-taking periods, and report submission channels, please refer to “Notification of Thai Food and Drug Administration: Risk-Based Approach Safety Monitoring Program (Risk-Based Approach SMP)”.

2.1.2 Medical Devices

Marketing authorization holders, premises registrants and specification providers, have the duty to report problems of medical devices used in human beings and animals, covering both in vitro diagnostic medical devices (IVDs) and non-IVDs. The Thai Food and Drug Administration requires the persons under the duty to report to submit the reports as follows:

1) Medical Device Defect or Adverse Event Report for a Domestic Case (Form Ror Mor Por 1);

2) Device Defect and Adverse Event Summary Report for Foreign Cases (Form Ror Mor Por 2);

3) Field Safety Corrective Action Report for Both Domestic and Foreign Cases (Form Ror Mor Por 3). In the case where product recall is necessary in Thailand in order to ensure the safety in using the devices, the marketing authorization holders, premises registrants and specification providers shall take action in accordance with the “Guidance for Medical Device Industry on Product Recall”.

For more information regarding reporting scope, minimum criteria for reporting, documentation for report submission, reporting timeframe, and report submission channels of all 3 aforementioned reports, please refer to the “Guidance for Medical Device Industry: Reporting of Device Defects, Adverse Events and Field Safety Corrective Actions”. In preparing the reports, the IMDRF terminologies shall be used.