BACKGROUND Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved he...

Background The unregulated availability and irrational use of tuberculosis (TB) medicines is a major issue of public health concern globally. Governments of many low- and middle-income countries (LMICs) have committed to regulating the quality and availability of TB medicines, but with variable success. Regulation of TB medicines remains an intractable challenge in many settings, but the reason...

INTRODUCTION ................................................................................... 532 I. OVERVIEW OF SMART GRID DEVELOPMENT ....................... 533 II. WHY NUSP-CONSUMER INTERACTIONS SHOULD BE REGULATED .............................................................................. 534 A. What are NUSPs and How Do They Interact with Consumers? ....................................

Recommendations published by WHO are intended to be scientific and advisory. Each of the following sections constitutes guidance for national regulatory authorities and for the manufacturers of biological products. If a national regulatory authority so desires, these Recommendations may be adopted as definitive national requirements, or modifications may be justified and made by the national re...

The Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law on June 22, 2009, and provided the Food and Drug Adinistration (FDA) broad regulatory authority with repect to the manufacture, marketing, and distribution of obacco products. The three public health goals of the enter for Tobacco Products (CTP), FDA, are to prevent outh initiation of tobacco use, decrease harm and/...

Independent regulatory authorities are expected to act as apolitical agents prevent market failures in the sector they regulate. However, according political signal theory, cannot escape interventions and control of power. In addition, capture regulation is designed operated for benefit dominant capital groups sector. This article applies both theories case Türkiye’s radio TV Based on our analy...

BACKGROUND This scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for effective pharmacovigilance. METHODS Si...

This issue brief examines an unprecedented use of state health insurance regulatory authority to promote health system reform. In 2004, the Rhode Island legislature created the Office of the Health Insurance Commissioner (OHIC) with authority not granted to state health insurance regulatory agencies in other states. Specifically, the legislation instructed OHIC to direct insurers toward policie...