1. 1 |1 | National Regulatory System, Status of vaccine indicators Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI) Thailand 23 - 27 Jul 2012

2. 2 |2 | National Regulatory System, Status of vaccine indicators PMS function assessor team Dr. Ananda Amarasinghe Consultant Epidemiologist EPI Unit MOH Colombo Sri-Lanka Dr. Ajay Kera, Deputy Commissioner, Ministry of Health & Family Welfare New Delhi, India Dr. Dina Pfeifer, Regional Advisor EPI, WHO regional Office for Europe Mr. Stephane Guichard, Vaccine Supply and Quality, Immunization and Vaccine Development, WHO regional Office for South East Asia

3. 3 |3 | National Regulatory System, Status of vaccine indicators Place and institutions visited Team 1: Visited Khon Kaen –Dr. Ajay Khera, Dr. Dina Pfeifer, Dr. Darin Areechokchai BOE/MOPH, Ms Papaiji Suangtho BOE/MOPH, Mr. Padejsak Chobdham Bureau general Communicable Department. Team 2: Visited Angthong province –Dr. Ananda Amarasinghe, Mr. Stephane Guichard, Mrs Kanoktip Thiparat BOE/MOPH and Mrs Porpit Barinsathien MOPH.

4. 4 |4 | National Regulatory System, Status of vaccine indicators Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI) Function status NRA FunctionYearIndicator Estimated Indicator implemented %Sub- indicators Function Status Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI) Before 2007 Not implemented Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI) 2007- 2008 Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI) 2012 7794.23 Implemented

5. 5 |5 | National Regulatory System, Status of vaccine indicators Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI) Indicators results IndicatorsIndicators achieved Indicator estimated Indicators percent PV01: Institutional regulations and Guidelines for the monitoring and management of adverse events following immunization (AEFI) 44100 PV02: Quality Management System for pharmacovigilance activities2.5383 PV03: Human resource management2367 PV04: Routine and functional system for regular review of safety and efficacy of the vaccine product for regulatory action 77100 PV05: Capacity to detect and investigate significant vaccine safety issues44100 PV06: Regulatory action regarding vaccine performance22100 PV07: Communication system is in place to periodically inform stakeholders about AEFI information. 33100 IndicatorsIndicators achieved Indicator estimated Indicators percent PV01: Institutional regulations and Guidelines for the monitoring and management of adverse events following immunization (AEFI) 44100 PV02: Quality Management System for pharmacovigilance activities2.5383 PV03: Human resource management2367 PV04: Routine and functional system for regular review of safety and efficacy of the vaccine product for regulatory action 77100 PV05: Capacity to detect and investigate significant vaccine safety issues44100 PV06: Regulatory action regarding vaccine performance22100 PV07: Communication system is in place to periodically inform stakeholders about AEFI information. 33100

6. 6 |6 | National Regulatory System, Status of vaccine indicators Strengths The system has significantly improved since the last NRA assessment in 2008. PMS system well established system AEFI are notifiable under the national disease surveillance system Expertise available at central, provincial and regional levels The country has a good investigation capacity to address vaccine safety and performance. Regular meetings at provincial and regional levels are conducted to review and analyze AEFI reports with good interactions with central level which review all cases. Information feedback is provided through the MOPH internet and periodic reports are prepared by BOE/AEFI. The system capture serious and non-serious AEFI throughout the National Immunization program Regular training of staff at every levels.

7. 7 |7 | National Regulatory System, Status of vaccine indicators Areas for improvement QMS implemented in NRA but not fully extended to BOE to cover detection, reporting and detailed analysis including feed back. Analysis methodology e.g.: analysis by rates, by dose of vaccines, by product,… To address under-reporting there are needs to standardized selected non-serious AEFI by applying simplified Brighton case definition. Further improvement of the system requires increased HR capacity at central level. Need to be more actively engaged in international/regional PMS activities to foster capacity building and keep abreast of latest regulatory requirements. E.g participation in NRA assessment, facilitating training organized by WHO in other countries

8. 8 |8 | National Regulatory System, Status of vaccine indicators Khob Kun Khab !