ABSTRACT
In recent times the apparent upsurge in the popularity and use of herbal medicines can be related to the success in their use for the management of certain important diseases, empirical proof of efficacy and safety, enhanced dosage form design and better tolerance among others. In this study the quality of some herbal medicines sold in Nigeria were evaluated for basic pharmaceutical quality and compliance to regulatory guidelines. Samples of sixteen frequently used herbal products were collected from Pharmacy stores (Ps) and Patent Medicine stores (PMs) across two states and the Federal Capital Territory. The dosage form, organoleptic properties, moisture content, weight/volume uniformity as well as compliance to regulatory guidelines were evaluated. Sixty percent of the samples were liquids, thirty percent were oral bulk powders and ten percent were capsules. None of the products complied completely with the regulatory requirement stipulated for finished herbal products in Nigeria while only ten percent of the products samples complied with the basic physicochemical properties required for pharmaceutical quality. Consequently, there is a compelling need for the regulatory authorities to ensure stringent quality surveillance and enforcement of guidelines to ensure that herbal medicines are of standard quality.
ABSTRACT
In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.
ABSTRACT
<b>Background:</b> Re-revision of the Ethical Guidelines for Clinical Study (EGCS) in Japan is planned in 2013. It is important to ascertain the current situation of physicians' understanding to conduct clinical trials. It seems that the difference in regulatory processes between commercial and non-commercial clinical trials has caused significant confusion for physicians in conducting clinical trials in Japan.<br>This survey was undertaken in order to improve awareness of the differences between both types of clinical trials. Furthermore, this survey examined whether it was effective to promote about clinical trials under newly introduced regulatory guidelines and to examine the subsequent willingness of physicians to conduct such clinical trials.<br><b>Methods:</b> From 24<sup>th</sup> March to 24<sup>th</sup> April 2009 inclusive, a questionnaire survey was conducted targeting 286 physicians working at Shiga University of Medical Science Hospital. A follow-up survey was conducted among 109 participants at a lecture about clinical trials on 8<sup>th</sup> July 2009.<br><b>Results:</b> Physicians who had prior knowledge of the regulations, purposes, or support systems for commercial and non-commercial clinical trials responded positively that they were more likely to conduct clinical trials, while physicians who had no prior knowledge of them responded negatively. Both groups reported that their daily working pressures and cumbersome regulatory processes prevented them from conducting clinical trials.<br><b>Conclusion:</b> Japanese physicians lack knowledge and information about clinical trials, leading to negative perceptions and reduced willingness to conduct such studies. Thus, the introduction of any strict and complex regulations should be approached carefully when the environment for clinical trials has not yet been established.