Generic placeholder image

Current Traditional Medicine

Author(s): P. Dheeraj Krishna*, M.P. Gowrav, Mahendran Bhaskaran and Kruthika M.R.

DOI: 10.2174/2215083810666230822113615

DownloadDownload PDF Flyer Cite As
Current Regulations of Herbal Medicines in the US and EU

Article ID: e220823220172 Pages: 11

  • * (Excluding Mailing and Handling)

Abstract

Background: If a herbal pharmaceutical is intended to impact the function of the human organism, it is categorized as a medication or a nutritional supplement. According to the FDA, the medicine must be offered under a New Drug Application (NDA). The European Medicine Agency (EMA) has established two methods for registering herbal medicals: Under Directive 2001/83/EC, a full marketing authorization (MA) is obtained by submitting a dossier containing data about the quality, safeness, and effectiveness of pharmaceuticals, which include physical and chemical, biological, or microbiological tests, as well as pharmacological, toxicological, and clinical trial documentation; There is a simplest technique under Directive 2004/24/EC for classical herbals that do not needs professional monitoring and where the indication of long history use of pharmaceuticals exists and appropriate relevant journals to illustrate a very well medicinal usage is not provided.

Aim: A study about the regulatory status of herbal drugs/products was conducted in America and Europe to understand the various classes under which the sale of herbal goods is authorized and their premarketing criteria.

Materials and Methods: This study has been performed by gathering information from the official websites of the USFDA and EMA.

Results: A thorough evaluation was carried out in order to identify the impediments to the harmonization of herbal goods.

Conclusion: Aside from the challenges of herb supply and conservation, it has been shown that there is a lack of uniformity in the regulatory standards of herbal supplements globally. These are impeding international commerce and the expansion of the herbal goods market. USFDA classifies botanical items as pharmaceutical, nutrition, or dietary supplement based on the indications or ultimate use.

Graphical Abstract

[1]
Food and Drug Administration. Rockville: U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER): Guidance for Industry, Botanical Drug Products Online Resource. 2004. Available from: http://www.fda.gov/cder/guidance/index.htm
[2]
Official Journal of the European Union: Directive 2004/24/EC; 31st March. 2004. Available from: http://www.eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ
[3]
Food and Drug Administration. Rockville: U.S. Department of Health and Human Services, Dietary Supplements Guidance Documents and Regulatory Information Online Resource. 2014. Available from: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/default.htm
[4]
Nutrition, Center for Food Safety and Applied. “Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” U.S. Food and Drug Administration 2020. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling
[5]
Nutrition, Center for Food Safety and Applied. “New Dietary Ingredients in Dietary Supplements - Background for Industry.” FDA. 2021. Available from: https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/new-dietary-ingredients-dietary-supplements-background-industry
[6]
Nutrition, Center for Food Safety and Applied. “Alerts, Advisories & Safety Information.” FDA. 2017. Available from: https://www.fda.gov/food/recalls-outbreaks-emergencies/alerts-advisories-safety-information
[7]
Infant Formula Guidance Documents & Regulatory Information. 2019. Available from: https://www.fda.gov/food/guidance-docum ents-regulatory-information-topic-food-and-dietary-supplements/infant-formula-guidance-documents-regulatory-information
[8]
FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022). 2022. Available from: https://www.fda.gov/food/outbreaks-foodborne-illness/fdainvestigation-cronobacter-infections-powdered-infant-formulafebruary-2022#:~:text=Updates%20February%202022%20%2D%20June%202022&text=Questions%2FGet%20Assistance.-
[9]
Nutrition C for FS and A. Dietary Supplement Labeling Guide 2018. Available from: https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide [Accessed on: 2022 Dec 2].
[10]
Nutrition C for FS and A. Dietary Supplements Guidance Documents & Regulatory Information. 2020. Available from: https://www.fda.gov/food/guidance-documents-regulatoryinformation-topic-food-and-dietary-supplements/dietarysupplements-guidance-documents-regulatory-information [Accessed on: 2022 Dec 2].
[11]
EMA. 7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Committee on Herbal Medicinal Products (HMPC) Guideline on specifications: test procedures and acceptance criteria for herbal substances 1 , herbal preparations 2 and herbal medicinal products 3 /traditional herbal medicinal products Final. 2011. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-specifications-test-procedures-acceptance-criteria-herbal-substances-herbal-preparations_en.pdf [Accessed on: Dec 2, 2022].
[12]
Harborne JB. Phytochemical Methods: A Guide to Modern Techniques of Plant Analysis. (3rd ed.). New York: Chapman and Hall Co. 1998; pp. 1-302.
[13]
Fernandes FHA, Salgado HRN. Gallic acid: review of the methods of determination and quantification. Crit Rev Anal Chem 2016; 46(3): 257-65.
[http://dx.doi.org/10.1080/10408347.2015.1095064] [PMID: 26440222]
[14]
EMA. Committee for medicinal products for human use (CHMP) committee for medicinal products for veterinary use (CVMP) guideline on specifications: test procedures and acceptance criteria for herbal substances 1 , herbal preparations 2 and herbal medicinal products 3 /traditional herbal medicinal products discussion at the HMPC draft agreed by quality working party april 2005 adoption by CHMP for release for consultation adoption by CVMP for release for consultation. 2006. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-specifications-test-procedures-acceptance-criteria-herbal-substances-herbal-preparations/traditional-herbal-medicinal-products-revision-1_en.pdf [Accessed on: Dec 2, 2022].
[15]
a) EMA. New EMA Guideline on Specifications for Herbal Medicinal Products - ECA Academy. 2015. Available from: www.gmp-compliance.org [Accessed on: Dec 2, 2022].;
b) Available from: https://www.gmp-compliance.org/gmp-news/new-ema-guideline-on-specifications-for-herbal-medicinalproducts
[16]
Calapai G. European legislation on herbal medicines: a look into the future. Drug Saf 2008; 31(5): 428-31.
[17]
ICH. ICH Topic Q 6 A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical substances step 5 note for guidance specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. 2000. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-6-test-procedures-acceptance-criteria-new-drug-substances-new-drug-products-chemical_en.pdf [Accessed on: Dec 2, 2022].
[18]
Pharmapproach. Quality Control Tests for Tablets. Pharmapproach. com 2018. Available from: https://www.pharmapproach.com/quality-control-tests-for-tablets/2/ [Accessed on: Dec 2, 2022].
[19]
Admin. Specific requirements for manufacture of oral liquids. Pharmaceutical Guidelines. 2019. Available from: https://www.pharmaguideline.net/specific-requirements-for-manufacture-of-oral-liquids/ [Accessed on: Dec 2, 2022].
[20]
The European Medicines Agency Reflection paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products Available from: http://www.emea.europa.eu/pdfs/human/hmpc/25362907en.pdf
[21]
Health C for D and R. Premarket Notification 510(k). FDA. 2021. Available from: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k [Accessed on: Dec 2, 2022].