Quote from VigiServe Admin on November 27, 2020, 1:43 PM

ONLINE REPORTING

In Thailand, Pharmacovigilance is a mature, ICH-aligned system enforced by the Thai Food and Drug Administration (Thai FDA). The framework is stringent, emphasizing electronic reporting and mandatory post-marketing surveillance for new products.

 

1. Clinical Safety (Clinical Trials)

Safety monitoring adheres to ICH GCP standards and requires strict reporting protocols.

 

• Approvals: Clinical Trial Applications (CTA) must be approved by the Thai FDA.

   

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) aligned with ICH E2A:

   

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format).

• Oversight: Sponsors manage causality assessment and must report to both the Thai FDA and Ethics Committees.

2. Post-Marketing Pharmacovigilance

Thailand imposes robust post-approval obligations, including a mandatory surveillance period for new drugs.

 

• Personnel: A Local Responsible Person (LRP) is mandatory. This individual must be a pharmacist or physician residing in Thailand, responsible for oversight and liaison with the FDA.

• Documentation: A Pharmacovigilance System Master File (PSMF) is required. It does not need to be registered but must be maintained and available for inspection.

   

• Incident Reporting (ICSRs):

  • Serious Cases: Report within 15 calendar days.

  • Non-Serious Cases: Report within 90 calendar days.

  • Submission: Electronic reporting via Thai Vigibase (E2B(R3) compatible) is required.

     

• Risk & Periodic Reporting:

  • PSURs: Submitted in ICH E2C(R2) format. Typically required every 6 months for the first 2 years, then annually.

  • Risk Management Plans (RMPs): Mandatory for new chemical entities, biologics, and biosimilars. Must include a Thailand-specific annex.

     

  • Safety Monitoring Program (SMP): A mandatory post-marketing surveillance period (usually 3–5 years) applies to new drugs (Safety Monitoring Program), during which stricter reporting rules apply.

Summary of Requirements

Component	Requirement in Thailand
Regulatory Authority	Thai Food and Drug Administration (Thai FDA)
Local Personnel	Mandatory LRP (Pharmacist/Physician)
PSMF	Required (Maintained locally)
SUSAR Reporting	7 days (fatal) / 15 days (other serious)
ICSR Timelines	15 days (serious) / 90 days (non-serious)
RMPs	Mandatory (with Thai Annex)
Special Requirement	Mandatory Safety Monitoring Program (SMP) for new drugs (3–5 years)