Regulatory authorities European Medicines Agency

The Committee was informed by the European Medicines Agency (EMEA) of a proposed approach to facilitate inspections and to avoid duplication of inspections. A GMP database was being established in the European Union by Member States that would provide information on and outcome of inspections. The database was expected to be released in 2006. Access rights were being discussed with WHO, the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the European Directorate for the Quality of Medicines (EDQM) and other organizations. Different levels of access will exist including one for public access and others for national medicine regulatory authorities, WHO and PIC/S. 

Approval by the regulatory authorities, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), as having clinical advantages over current treatments and a suitable safety prohle. 

The European Medicines Agency (EMEA) is a decentralized body of the European Union created with the objective to harmonize regulatory activities in Europe. EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. Its main responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use. 

In 1996 and 1997 the International Conference on Harmonization (ICH) published guidelines for analytical method validation [18]. These documents present a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan, and the United States. Regulatory agencies have emitted documents, largely inspired by ICH documents. It is the case of the FDA [19, 20], the European Medicines Agency (EMA) [21,24], and the Australian Pesticides and Veterinary Medicines Authority [25], to name just a few. 

The hepatotoxic effects of black cohosh have been analysed by the Dietary Supplement Information Expert Committee of the US Pharmacopeia s Council of Experts. Reports were obtained from diverse sources, including the European Medicines Agency [28 ]. There were 30 reports, all of which were considered to be possibly associated with the plant, using Naranjo s algorithm. The Expert Committee proposed that black cohosh products should be labeled with a cautionary statement. This is a change from a previous in 2002, which required no such statement. Meanwhile, other national regulatory authorities have issued similar warnings [29 , 30 , 31 , 32 ]. 

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