Pharmaceutical Regulatory Affairs: Open Access

The objective of present review is to offer an overview of post marketing surveillance of drug eluting stents in India and European Union (EU). The drug eluting stents are used for the treatment of coronary angioplasty Drug eluting stents can significantly reduce the rate of restenosis by 60-75% as compare to bare metal stents. New technologies are often introduced into the market without proper safety and effectiveness data. To know about the safety and effectiveness of the drug eluting stents after marketing, Post marketing surveillance plays a vital role it includes Periodic Safety Update Report (PSUR) and Post Marketing Clinical Follow Up Studies (PMCF) for the identification of residual risk during the process and also explained about the functions of manufacturer and notified bodies, regulatory requirements of drug eluting stents in India and European market.

The implementation of expert information systems in healthcare is a way to achieve better care for the patients, as well as effective management of the healthcare sector. The electronization of the drug therapy process brings a lot of advantages-time and resources are spared, the patient's treatment plan is optimized and the engagement of the patient and their satisfaction with the medical service increases. The implementation of a pharmaco-therapeutic information system in Bulgaria is based on the experience of some European countries with similarly functioning systems, as well as the good practices in this field. Despite some difficulties, accompanying its implementation, the basic functionality of the system will provide support to professionals in deciding on their patients' drug therapy. Upgrading and improving the system in the coming years will lead to a greater degree of refinement and individualization of medical prescriptions.

Outsourcing clinical trials has been a subject of both controversy and relevance in the pharmaceutical community. It is an important part of drug development that not only reveals the effectiveness of new medications, but it also brings on such a powerful effect on public health. A definition and a brief historical overview are discussed in-depth in this article, as well as its prevalence, business strategies, and need for transparency.

Development of a protocol for a nonclinical safety study to evaluate the safety profile of an investigational therapeutic, whether it is a toxicology or safety pharmacology study, must not be conducted in haste. The evaluation of this novel therapeutics relies on the integrated strategy developed by the scientific team, which may include the pharmaceutical company and the services of a contract research organization. All nonclinical study protocols involving the use of live animals require the inclusion of the Institutional Animal Care and Use Committee (IACUC) and staff veterinarians during the review of the study protocol. The team, as a whole, must endure a frank, honest, and open discussion regarding study design and animal welfare issues. All available information regarding the test material should be shared with all parties in a manner and time that allows for constructive protocol and treatment strategy development. The intent of nonclinical safety assessments is driven by both administrative guidelines from drug regulatory agencies and statutory (legal) controls of federal laws. In working with test articles, particularly for small molecules, the probability of unexpected findings is relatively high. The research team must maintain the highest standards of animal care throughout this process which is complicated by the fact that when animal health and welfare issues occur they must be remedied fast, efficiently, and transparently. We review the pitfalls of safety assessment strategies and offer some industry standard resolutions that may help to make the road to market a little easier. The paper is written based on small molecule development, but many of the points would also apply to biopharmaceuticals as well.

Alternative medicines remain under the regulatory control of the US Food and Drug Administration. A number of competent and professional researchers in the field of drug development have touted and proclaimed the safety and efficacy of smoked Cannabis sativa and kratom. In 2017, under international and national statutes, neither Cannabis sativa nor kratom are medicines. The community of scientists must maintain an objective scientific, verifiable and legally-sound methodology and lexicon in developing supportive data to advance constituents of the plant for NDA approvals. Use of the term “medical marijuana” is inappropriate.