Current Issue : April-June Volume : 2015 Issue Number : 2 Articles : 3 Articles
Orphan diseases are typically those that are having no commercial incentives to research and develop actual therapies. More than 25 years of orphan drug regulations have yielded several new treatments for patients with rare diseases. To boost the pharmaceutical companies to invest in the development of orphan drug, various countries, beginning with the USA, they have announced their own regulations to provide suitable motivations. There is a significant degree of similarity in the incentives provided from one nation to another and this variety from market exclusivity for the product in its proposed indication (the most important incentive) to tax credits and reduction or waivers of fees. In this article it introduces the orphan drugs and gives legal framework for its regulation in US and Japan. Along with specifications for the orphan drugs it includes its requirements and features of Fast-track Approval process for quick Marketing authorization....
Pharmacovigilance is a science to prevent adverse drug reaction (ADR) is a major thought for each country that led to the emergence of various national ADR monitoring centers across the world. All these centers are connected to the single international center at Uppsala, Sweden, established by the WHO. This review presents the history and importance of Pharmacovigilance in present day scenario and also highlights the various methods of reporting or documenting ADRs such as spontaneous drug monitoring, general practice research database (GPRD) and prescription monitoring (PEM). Each method is having pros and cons. Therefore, the only way to improve the role of pharmacovigilance is to educate people regarding its importance in rational drug use. The thalidomide disaster was marked as the era beginning for pharmacovigilance. Such examples from today’s world include the withdrawal of Rosiglitazone and Aprotinin from the market due to their greater ADRs. Only through pharmacovigilance one can ensure that the patient receives right drugs. Lastly, it can be concluded that pharmacovigilance is the necessity of today’s world and it should be brought to the global level....
Aerosol drug delivery systems are gaining much more importance in present and have a great advantage over other route of administration. Dry Powder Inhaler was introduced to deliver asthma medication in an exceedingly convenient and reliable multi dose preparation. The key elements of the DPIs device play important role in determining drug delivery to the lungs, hence the regulation of the DPIs device is Important. Centre for drug evaluation and research (CDER) under FDA and Committee for proprietary medicinal products (CPMP) under EMA is responsible for regulation of DPI in US and Europe respectively. The Registration of DPIs in US as well as Europe is done through Common Technical Document (CTD) format. This article gives information of regulatory requirements of quality section of DPIs in US and Europe. The regulatory requirements of quality section are varying from each other so it is challenging for globalized pharmaceutical companies to develop DPIs which comply with regulatory requirements of both countries....
Loading....