The conjunctival provocation test (CPT) is a diagnostic procedure for testing airborne allergens causing allergic rhinoconjunctivitis [1,2]. It has been thoroughly evaluated with regard to its precision [3] and compared with nasal provocation tests [4]. Nowadays, the CPT is used for evaluation of allergic rhinoconjunctivitis [5,6] and is accepted by regulatory authorities as an outcome paramete...

In May 2016, the Food and Drug Administration extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product (Deeming Rule). This authority now includes, but is not limited to, electronic nicotine delivery systems (ENDS), such as electronic cigarettes, as well as all cigars, pipes, and hookahs (waterpipes). The FDA's Center for Tobacco Products has bee...

OBJECTIVE The purpose of this article is to give an overview of the complexities and unexpected regulatory requirements for obtaining approval of multinational and multicentre non-interventional studies (NIS) in the European Union (EU). METHODS The websites of national competent authorities (CAs), ethics committees (ECs) and data protection (DP) authorities were consulted to find regulations ...

This paper reports a typical statin-related adverse reaction from a red yeast rice (RYR) supplement and the analytical findings from the supplement. It also examines the regulatory framework governing botanical supplements in Europe. Two key events that shaped the current regulatory framework are reviewed. First, the Hecht-Pharma judgement by the European Court of Justice (ECJ) that inverted th...

The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug d...

There are various kinds of good laboratory practice (GLP) monitoring authorities (MAs) in the world. Some countries have only one MA, while others, including Japan, have more than one MA. In addition, each MA has its own relationship with regulatory authorities (RAs), receiving authorities (RcAs) and industry based on the internal regulatory systems. There are eight GLP MAs in Japan. This numbe...

OBJECTIVES To identify the status of compliance and enforcement of New Zealand's Fencing of Swimming Pools Act (FOSP Act), 10 years after its introduction, and to identify methods for improving both compliance with the act and the process of enforcement. METHODS A postal questionnaire was sent to all 74 authorities in New Zealand in which they were asked questions about their enforcement of t...

Confidence in vaccine safety is critical to national immunization strategies and to global public health. To meet the Millenium Development Goals, and buoyed by the success of new vaccines produced in developing countries, the World Health Organization has been developing a strategy to establish a global system for effective vaccine pharmacovigilance in all countries. This paper reports the fin...