Risk-based Approach of Medicines Clinical Trial for Applying in Thailand

Authors

  • Patcharaphun Kidpun Medicines Regulation Division, Food and Drug Administration, Nonthaburi, Thailand
  • Akanid Wapeewuttikorn Medicines Regulation Division, Food and Drug Administration, Nonthaburi, Thailand

References

Congress of the United States. Congressional Budget Office. Research and Development in the Pharmaceutical Industry [Internet]. 2021 [cited 2023 Oct 19]. Available from: https://www.cbo.gov/publication/57126

Tršek A, Jeran M, Smerkolj N. Pharmaceutical and financial aspect of research and development in Nine Pharmaceutical Industry Giants [Internet]. 2021 [cited 2023 Oct 19]. Available from: https://www.researchgate.net/publication/349536568

พระราชบัญญัติ ยา (ฉบับที่ 6) พ.ศ. 2562. ราชกิจจานุเบกษา เล่มที่ 136, ตอนที่ 50 ก (ลงวันที่ 16 เมษายน 2562).

European Medicines Agency. Regulation (EU) No 536/2014 OF the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [Internet]. 2014 [cited 2023 Oct 10]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02014R0536-20221205

Petrini C. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview. Ann Ist Super Sanita 2014;50(4) :317-21.

Therapeutic Goods Administration. Clinical trials [Internet]. 2023 [cited 2023 Oct 10]. Available from: https://www.tga.gov.au/products/unapproved-therapeutic-goods/clinical-trials

Therapeutic Goods Administration. Australian clinical trial handbook Guidance on conducting clinical trials in Australia using “unapproved” therapeutic goods. version 2.4, August 2021 [Internet]. 2021 [cited 2023 Oct 10]. Available from: https://www.tga.gov.au/sites/default/files/australian-clinical-trial-handbook.pdf

Medicines and Healthcare products Regulatory Agency. Risk-adapted approaches to the management of clinical trials of investigational medicinal products [Internet]. 2011 [cited 2023 Oct 10]. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/343677/Risk-adapted_approaches_to_the_management_of_clinical_trials_of_investigational_medicinal_products.pdf

Medicines and Healthcare Products Regulatory Agency. MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years [Internet]. 2023 [cited 2023 Oct 10]. Available from: https://www.gov.uk/government/news/mhra-to-streamline-clinical-trial-approvals-in-biggest-overhaul-of-trial-regulation-in-20-years

Health Sciences Authority. Regulatory overview of clinical trials [Internet]. 2022 [cited 2023 Oct 5]. Available from: https://www.hsa.gov.sg/clinical-trials/overview

Health Sciences Authority. Health products (clinical Trials) regulations 2016 [Internet]. 2016 [cited 2023 Oct 10]. Available from: https://sso.agc.gov.sg/SL/HPA2007-S331-2016

Benjamin Gaw B, Tony Yeo, and Corinne Chew, Drew & Napier LLC. Life sciences regulation in Singapore: overview [Internet]. 2023 [cited 2023 Oct 10]. Available from: https://ca.practicallaw.thomsonreuters.com/6-567 9006?transitionType=Default&contextData=(sc.Default)&firstPage=true

Health Sciences Authority. Medicines (clinical trials) regulations 2016 [Internet]. 2016 [cited 2023 Oct 10]. Available from: https://sso.agc.gov.sg/SL/MA1975-S335-2016

Health Sciences Authority. CLINICAL TRIALS GUIDANCE, DETERMINATION OF WHETHER A CLINICAL TRIAL REQUIRES CLINICAL TRIAL AUTHORISATION (CTA), CLINICAL TRIAL NOTIFICATION (CTN) OR CLINICAL TRIAL CERTIFICATE (CTC) [Internet]. 2021 [cited 2023 Oct 10]. Available from: https://www.hsa.gov.sg/docs/default-source/hprg-io-ctb/hsa_gn-ioctb-01_cta_ctn_ctc_1mar2021.pdf

Health Sciences Authority. CLINICAL TRIALS GUIDANCE REGULATORY REQUIREMENTS FOR NEW APPLICATIONS AND SUBSEQUENT SUBMISSIONS [Internet]. 2021 [cited 2023 Oct 10]. Available from: https://www.hsa.gov.sg/docs/default-source/hprg-io-ctb/hsa_gn-ioctb-04_new_and_subsequent_appl_28apr2021.pdf

Organization for Economic Co-operation and Development. Recommendation of the council on the governance of clinical trials [Internet]. 2012 [cited 2023 Oct 10]. Available from: https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0397

Downloads

Published

27-02-2025

How to Cite

1.
Kidpun P, Wapeewuttikorn A. Risk-based Approach of Medicines Clinical Trial for Applying in Thailand. Thai Food and Drug J [internet]. 2025 Feb. 27 [cited 2025 Mar. 15];32(1):5-17. available from: https://he01.tci-thaijo.org/index.php/fdajournal/article/view/277534

Issue

Section

Academic Article