Pharmaceutical information systems Internet

This chapter provides a brief overview of the new European pharmaceutical registration system and aims, in particular, to act as a point of cross reference from the chapters on the national registration systems of the individual member states (MS) of the European Union (EU). Further information may be obtained through the internet at http //www.Heads.medagencies.org/html. 

As nutraceuticals are not classified as medicinal products, their manufacture is often not legally regulated. Nutraceuticals are widely available for sale, and the many suppliers may formulate their products differently this leads to variations between products of different manufacturers. Products available for purchase are not necessarily of the same quality as those used in reported clinical trials. For effective and safe use, the products must contain the same active ingredient, at the same concentration, have known bioavailability per delivery system, and state detailed and correct information on packaging or patient leaflet. However, possibly due to purchase from non-pharmaceutical sources such as the Internet, there is often little information on efficacy, drug interactions, effect of long-term use, abrupt discontinuation, or potential adverse effects available to patients. 

Gender-related data from the FDA are more readily available as the FDA continues to increase its computer ability, and pharmaceutical firms utilize computer-assisted NDAs and increase their efforts to adequately power the studies to find differences. Unified systems and formats would enhance this. The information is included in the Summary Basis for Approval or in the Medical Reviewer s Report. Either should be available through the Internet at www.fda.gov./cder under New Approvals . 

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