Scholarlink

Background <p>Pharmacovigilance is the science and practice of safety monitoring for medicines-related problems; it is also applicable to a broader scope of health products, including natural health products (NHPs). The NHPs industry is a key stakeholder in pharmacovigilance for NHPs, but academic review of regulatory requirements concerning pharmacovigilance for the NHPs industry is limited.</p> Objectives <p>To map, describe and compare regulatory requirements for the NHPs industry regarding pharmacovigilance for NHPs in selected international jurisdictions.</p> Methods <p>The top 30 countries/regions from the World Health Organization’s (WHO) list of nations with the highest Current Health Expenditure in 2020 were identified. For these countries/regions, publicly accessible regulatory instruments describing pharmacovigilance requirements for the NHPs industry, available in English on official governmental websites and selected secondary resources, were sought.</p> Results <p>Regulatory documents from 12 countries/regions (Australia, Brazil, Canada, China, India, Japan, Republic of Korea, South Africa, Switzerland, UK, USA and the EU) were included. Definitions of NHPs vary across jurisdictions, while regulatory frameworks most clearly diverge between single medicine-based systems that include NHPs, and those that apply separate medicine- and food-based primary legislation to different NHP categories. Most included jurisdictions require the NHPs industry (i.e., product sponsors, market authorisation holders, registration/license holders, manufacturers) to report serious adverse drug reactions (ADRs) within 15 days of becoming aware of such reports. However, requirements for submitting foreign ADR reports, periodic safety update reports, conducting literature screening, and employing a Qualified Person for Pharmacovigilance differ. In jurisdictions that apply separate medicine- and food-based primary legislation to different NHP categories, pharmacovigilance requirements for the industry correspondingly vary. There are usually fewer (or no) requirements for products regulated as food compared with those included under medicine-based regulations.</p> Conclusions <p>Pharmacovigilance regulatory requirements for the NHPs industry vary <i>between</i> and <i>within</i> countries/regions, primarily focusing on reporting serious ADRs. To support effective benefit–risk assessment of NHPs and safeguard public health, future policy-oriented research should assess the impact of these regulatory differences on industry practice and for pharmacovigilance for NHPs, examine requirements in countries not included here, and explore pathways towards international regulatory harmonisation.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Pharmacovigilance Regulatory Requirements for the Natural Health Products (NHPs) Industry in World Health Organization-Defined High Health Expenditure Countries (2020): A Scoping Review

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月28日

查看全文
  • Xin Yi Lim,
  • Sanyogita Ram,
  • Shane Scahill,
  • Joanne Barnes

摘要

Background

Pharmacovigilance is the science and practice of safety monitoring for medicines-related problems; it is also applicable to a broader scope of health products, including natural health products (NHPs). The NHPs industry is a key stakeholder in pharmacovigilance for NHPs, but academic review of regulatory requirements concerning pharmacovigilance for the NHPs industry is limited.

Objectives

To map, describe and compare regulatory requirements for the NHPs industry regarding pharmacovigilance for NHPs in selected international jurisdictions.

Methods

The top 30 countries/regions from the World Health Organization’s (WHO) list of nations with the highest Current Health Expenditure in 2020 were identified. For these countries/regions, publicly accessible regulatory instruments describing pharmacovigilance requirements for the NHPs industry, available in English on official governmental websites and selected secondary resources, were sought.

Results

Regulatory documents from 12 countries/regions (Australia, Brazil, Canada, China, India, Japan, Republic of Korea, South Africa, Switzerland, UK, USA and the EU) were included. Definitions of NHPs vary across jurisdictions, while regulatory frameworks most clearly diverge between single medicine-based systems that include NHPs, and those that apply separate medicine- and food-based primary legislation to different NHP categories. Most included jurisdictions require the NHPs industry (i.e., product sponsors, market authorisation holders, registration/license holders, manufacturers) to report serious adverse drug reactions (ADRs) within 15 days of becoming aware of such reports. However, requirements for submitting foreign ADR reports, periodic safety update reports, conducting literature screening, and employing a Qualified Person for Pharmacovigilance differ. In jurisdictions that apply separate medicine- and food-based primary legislation to different NHP categories, pharmacovigilance requirements for the industry correspondingly vary. There are usually fewer (or no) requirements for products regulated as food compared with those included under medicine-based regulations.

Conclusions

Pharmacovigilance regulatory requirements for the NHPs industry vary between and within countries/regions, primarily focusing on reporting serious ADRs. To support effective benefit–risk assessment of NHPs and safeguard public health, future policy-oriented research should assess the impact of these regulatory differences on industry practice and for pharmacovigilance for NHPs, examine requirements in countries not included here, and explore pathways towards international regulatory harmonisation.