ClinRegs Updates their Thailand Profile for Clinical Trials Regulatory Intelligence

Aug 30, 2019 | Clinical Trials, ClinRegs, Regulatory, Study Start-up, Thailand

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The Thailand Profile in ClinRegs has been reviewed and updated to reflect current requirements. Key updates are included below. ClinRegs is a TrialSite News favorite.

The Following Updates Occurred in ClinRegs:

  • Revised 2018 version of Notification of the Food and Drug Administration Regarding the Requirements for the Introduction or Placing of Drugs into the Kingdom for Clinical Trials
  • Publication of Notice of the Food and Drug Administration Regarding the Requirements for the Production of Modern Sample Medicine for Clinical Research Dated 17 September 2018, which amends drug import application filing requirements
  • Revised 2018 version of Notification Regarding the Requirements for Referral or Ordering in the Clinic for Clinical Research
  • Revised 2019 version of Drug Act B.E.2510 (A.C. 1967) and its Amendments, which includes the 2019 amendment giving the Ministry of Public Health and the Thai Food and Drug Administration broader authority in overseeing clinical research
  • Revised 2018 version of Notification of Food and Drug Administration: Rules, Procedures, and Conditions for Accepting Ethics Committee for Research Involving Human Subjects, which updates the 2013 requirements for ethics committee (EC) authorization

Specific Revisions to the Profile Include:

  • Details on the MOPH and the Thai FDA’s Secretary-General’s expanded role to change procedures, regulations, and conditions related to drug clinical research studies (See the Regulatory Authority topic)
  • Additional information on EC authorization requirements and EC approval procedures (See Ethics Committee topic)
  • Updated application requirements (See Scope of Assessment and Scope of Review sections)
  • More comprehensive information on safety reporting guidelines (See Safety Reporting section)

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