Guidelines Development on Claims and Claims Substantiation for Herbal Products in Thailand

Main Article Content

Daranee Pencharoen

Abstract

The objective of this research was to develop the guidelines on claims and claims
substantiation for herbal products which was suitable for the context of Thailand. Documentary research was used by reviewing and comparing the guidelines on claims and claims substantiation for herbal products in the selected countries. i.e., ASEAN, Australia, Singapore,Malaysia and Thailand. The results showed that “ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements”, the standard guidelinesfor ASEAN countries, was more comprehensive and flexible than the guidelines of otherASEAN countries including Thailand. However, the ASEAN guidelines did not cover all herbal products. The Australia guidelines was the most comprehensive when compared to the other countries but did not have the specific criteria of traditional medicines and herbal supplements. Therefore the ASEAN guidelines and some parts of the Australia guidelines were used as the references to develop the guidelines on claims and claims substantiation for herbal products in Thailand. The drafted version of the guidelines on claims and claims substantiation for herbal products in Thailand was prepared, consisting of the followings : (1) Introduction (2) Objective (3) Types of herbal products (4) Key principles of claims and claims substantiation for herbal products (5) Guidance of claims and claims substantiation for herbal medicinal products (6) Guidance of claims and claims substantiation for herbal health supplement products (7) Notes and (8) References.

Downloads

Download data is not yet available.

Article Details

Section
Research Article

References

1. กระทรวงสาธารณสุข กรมการแพทย์แผนไทยและการแพทย์ทางเลือก. แผนแม่บทแห่งชาติว่าด้วยการพัฒนาสมุนไพรไทย ฉบับที่ 1 พ.ศ. 2560-2564. พิมพ์ครั้งที่ 1. นนทบุรี: บริษัท ทีเอสอินเตอร์พริ้นท์ จำกัด; 2559.

2. สำนักงานคณะกรรมการกฤษฎีกา. (ร่าง) พระราชบัญญัติผลิตภัณฑ์สมุนไพร พ.ศ …. เรื่องเสร็จ ที่ 1609/2561.

3.ASEAN Harmonization of Traditional Medicines and Health Supplements. Report of twenty seventh meeting of the task force on ASEAN regulatory framework for traditional medicines and health supplements. 29-30 October 2018, Yogyakarta, Indonesia

4.U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Botanical
Drug Development Guidance for Industry. 2016 [Internet]. 2016 [cited 2018 Dec 12].Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidance/

5.European Medicines Agency. Herbal Medicinal Products. [Internet]. [cited 2018 Nov 29].
Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/
scientific-guidelines/multidisciplinary/multidisciplinary-herbal--medicinal-products

6.Department of Health. Therapeutic Goods Administration. Australian regulatory
guidelines for complementary medicines Version 8.0 April 2018. [Internet]. 2018
[cited 2018 Nov 23]. Available from: https://www.tga.gov.au/.../australian-regulatoryguidelines-
complementary-medicines/

7.Japan Pharmaceutical Manufacturers Association. Pharmaceutical Administration
and Regulations in Japan 2018. [Internet].2018 [cited 2019 Feb 11]. Available from:
http://www.jpma.or.jp/english/parj/

8.Association of South East Asian Nations (ASEAN). Annex VII : ASEAN Guidelines on claims and claims substantiation for traditional medicines and health supplements. Version 1.0 [Internet]. 2014 [cited 2018 Dec 7]. Available from: https://www.hsa.gov.sg/...HealthProducts/.../Annex/

9.Department of Health. Therapeutic Goods Administration. Permitted indications for listed
medicines, Guidance. Version 1.0 March 2018.[Internet]. 2018 [cited 2018 Nov 13]. Available
from: https://www.tga.gov.au/publication/permitted-indicatios-listed-medicines-guidance/

10.Department of Health. Therapeutic Goods Administration. Evidence guidelines:
Guidelines on the evidence required to support indications for listed complementary
medicines. Version 2.1 July 2014. [Internet]. 2014 [cited 2018 Nov 13].Available from: https://www.tga.gov.au/sites/default/foles/cm-guidance-listedmedicines140724.pdf

11.Department of Health. Therapeutic Goods Administration. Assessed listed medicines
evidence guidelines. Version 1.1 August 2018. [Internet]. 2018 [cited 2018 Nov 13].
Available from: https://www.tga.gov.au/.../assessed-listed-medicines-evidenceguidelines

12.Health Sciences Authority. Complementary Health Products : Regulation of Traditional
Medicines, Regulation of Chinese Proprietary Medicines. [Internet]. [cited 2018 Nov 23].
Available from: https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/
Complementary_ Health_Products/

13.Health Sciences Authority. Regulatory guidance: Health supplements guidelines.Revised September 2018. [Internet]. 2018 [cited 2018 Nov 23]. Available from:https://www.hsa.gov.sg/...Health.../Health_Supplements/HS.Guidelines.pdf

14.Ministry of Health, Malaysia. National Pharmaceutical Regulatory Division. Drug
Registration Guidance Document (DRGD).2th ed September 2016, revised July 2018.
[Internet]. 2018 [cited 2018 Nov 23].Available from: https://www.npra.gov.my/images/Guidelines...DRGD/

15.Ministry of Health, Malaysia. National Pharmaceutical Regulatory Division. Guideline
on Natural Products with Therapeutic Claim. January 2019. [Internet]. 2019 [cited 2019
Feb 20]. Available from: https://www.npra.gov.my/.../NATURAL_PRODUCT_GUIDELINE_
FOR_THERAPEUTIC_CLAIM_210219_FINAL.pdf

16.สำนักงานคณะกรรมการอาหารและยา. สำนักยา.คู่มือหลักเกณฑ์การขึ้นทะเบียนตำรับยาแผนโบราณ;
2561.

17.สำนักงานคณะกรรมการอาหารและยา. หลักเกณฑ์การขึ้นทะเบียนตำรับยาพัฒนาจากสมุนไพร.
[อินเทอร์เน็ต]. [เข้าถึงเมื่อ 7 พ.ย. 2561]. เข้าถึงได้จาก: http://www.fda.moph.go.th/sites/drug/SharedDocuments/Herbs/

18.สำนักงานคณะกรรมการอาหารและยา. คู่มือสำหรับประชาชน : การขอประเมินการกล่าวอ้างทางสุขภาพ. [อินเทอร์เน็ต]. [เข้าถึงเมื่อ 7 พ.ย.2561]. เข้าถึงได้จาก: http://www.fda.moph.go.th/sites/food/manual/9.2_M44_Health_claims.pdf/