Pharmaceutical Regulatory Affairs: Open Access

In a recent series of unprecedented collaborative meetings between U.S. FDA members of the controlled substances staff (CSS) within the center for drug evaluation and research (CDER) and the pharmaceutical industry (pharmaceutical research and manufacturers association–PhRMA) members have delineated a “standard” for conducting preclinical abuse liability screening of all new molecular entities that affect the CNS. We argue for a “mind shift” in policies and methodologies used to quantify the potential discontinuation syndrome that may be engendered following abrupt cessation of repeated dose administrations of all New Molecular Entities under this new model. We argue against the use of the current “fixed dose” strategy to the more informative “escalating dose” or “equivalent dose” strategies that more accurately predicts the dependence potential of drug substances regardless of expected therapeutic doses.

Availability of modern medicine increased all over the world due to huge expansion of the global Pharma market. At the same time misuse as well as accessibility of the most of essential drugs to majority of the population was denied due to cost-effectiveness of healthcare delivery combined with poor procurement policies and poor prescribing practices. During the recent years, the national list of India has assumed immense importance to improve access to medicines in India. It is therefore necessary to understand policies and guidelines followed in developing WHO essential drug list and national list of essential medicines. In this review article history of essential drug list and important inclusions in NLEM 2015 and WHO EML 2015 were highlighted.

Tracking and tracing pharmaceutical products is a key element of any effective solution to the problem of counterfeit medicines. This paper aims to provide an updated assessment of the timeframes for implementing the European medicinal trace-and-trace system in the wake of the delays and uncertainties that stand in the way of meeting the deadlines proposed at the end of 2007. Across the USA, federal and state laws advocating ePedigrees (RFID) have been proposed and enacted to address the criminal activities and increasing threats to public health posed by counterfeit drugs. In order to implement the EU Directive, stakeholders have agreed to develop and implement an “end-to-end” concept aiming at verifying the packaging of medicinal products using a Data-Matrix Code.

Health is an integral part of human life. Therefore, an interactive working is potentially desired to improve the public health. Interprofessional collaboration also helps to improve the overall health care facilities. Hence, we need to design the new plans for dissemination of the relevant information in an innovative manner. Additionally, the academicians, government officials and health professionals have to understand the new evolving role of pharmacist. Who can provide the innovative schemes to establish the appropriate harmony among various explicitly different health care professionals? That will also help to achieve the Millennium Development Goals of World Health Organization and integrate the international health programs and care plans.

Brazilian health legislation on drug surveillance has been available for only four decades. This study aimed to analyze the chronological evolution of the pharmacovigilance legislation in Brazil. A critical review of the legislations and communications published between 1976 and 2015 was conducted. Sixty-two (62) documents were identified. Advancements in the assessment of health technologies occurred only after the publication of the National Drug Policy (1998), the foundation of the National Health Surveillance Agency (ANVISA), and the creation of the National Center for Drug Monitoring (2001). From 2009, pharmacovigilance practices became mandatory for marketing authorization holders. Despite recent, the regulatory advancements in pharmacovigilance in Brazil are equivalent to international practices. However, there is still a lack of regulations for biosimilars and veterinary medicines, of agility in reporting non-serious risks to manufacturers and health care services, and of encouragement for reporting technical complaints and quality deviations, which could improve and control post-marketing drug quality. It is necessary to encourage and develop strategies for the decentralization of pharmacovigilance actions to the whole country.

In recent few years, there are many epic Biological products are going off patent which has generated an abridged route for the Biosimilars products which relies on the extensive comparability testing against Reference Biological Products (RBP) assuring product’s quality, safety and efficacy. Biosimilars are product similar to biologics but not indicate to them. Thus they require distinct marketing approval with abounding documentation as they are not generic version of biologics. These made regulatory and administrators of different countries to establish strict balance between the cost benefit and risk management of the product. The first draft guideline for Biosimilars was established by Europe, subsequently Japan and USA has developed the draft guidelines. While recently India has established the biosimilars guideline in June 2012. India has vigorous Pharmaceutical Industry for the generic drug while it can become an emerging market for the Biopharmaceutical drug. The regulatory structure for the biosimilars in India is depicted in this article with comparison of the biosimilars guidelines established by India and WHO. The approval process will be based authenticating a comparability quality between the biosimilars products and original product due to small alteration may lead to intolerable modifications in safety and efficacy. In many cases nonclinical studies are more difficult and potentially expensive to perform where biosimilars are highly species specific. Thus there is need for stringent regulatory guidelines. The biosimilar market will soon be thriving above $ 80 billion price of drugs in next seven years.