International Journal of Drug Regulatory Affairs <p>IJDRA is Quarterly Open-access and peer-reviewed Journal circulated electronically and Print since 2013 to provide the quality information on the latest updates on Drug regulation. It is the first Journal for subject Drug Regulatory Affairs in India and it publishes Research articles, Review articles, and Case studies on all aspects of Drug Regulatory Affairs, Pharmaceutical Development,&nbsp;Medical and Health Sciences in association with Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India. The journal serves researchers from academia and industry and intended to be of interest to a broad audience of Pharmaceutical, Medical and Health professionals.</p> en-US <div align="justify"> <p>The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.</p> <p>I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.</p> <p><strong>Download link for <a href=""><em>COPYRIGHT FORM</em></a></strong></p> <p>&nbsp;</p> </div> (Dr. Jitendra Kumar Badjatya) Sun, 15 Dec 2019 17:42:28 +0000 OJS 60 Customers' Perceptions on Pharmaceutical Regulatory Service Quality in Ethiopia <p>Introduction: Service quality is a unique and abstract concept that is difficult to define and measure. It is an overall customer judgment that results from the comparison between service expectations and perceptions. There is no information on customers’ perception of pharmaceutical regulatory service quality in Ethiopia. Hence, this study aimed to assess customers’ perception of the Ethiopian Food, Medicine and Healthcare Administration and Control Authority’s pharmaceutical regulatory service quality.</p> <p>Materials and methods: Cross-sectional study design was conducted from March 30 to May 30, 2017. Using simple random sampling technique, 131 respondents were included in the study. Structured questionnaire adapted from the SERVQUAL model was used to collect the data. Paired sample t-test and descriptive statistics were used for data analysis.</p> <p>Results: The study found out that pharmaceutical regulatory service quality was low. Negative service quality gaps were observed in the five service quality dimensions and overall service quality. The widest service quality gap was in reliability and the narrowest gap was in the tangibility and assurance dimensions. The perception and expectation mean scores were 1.897±0.61 and 3.433±0.559 respectively.</p> <p>Conclusions: Only 21.4% of the customers perceived that there was good service quality in the Authority while 78.6% claimed as poor. The study showed that there are service quality gaps in the pharmaceutical regulatory services. Hence, managers should look into the unmet needs and expectations or low perceptions of customers; and formulate effective strategies to ensure provision of better service quality.</p> Kidanemariam G/Michael Beyene, Deribe Assefa Aga, Heran Gerba Borta, Mesafint Abeje Tiruneh Copyright (c) 2019 Kidanemariam G/Michael Beyene, Deribe Assefa Aga, Heran Gerba Borta, Mesafint Abeje Tiruneh Wed, 18 Dec 2019 07:52:06 +0000 Haemovigilance: New approach for safe Blood transfusion <p>Haemovigilance is an urgent need of the country to identify and prevent occurrence or recurrence of transfusion related adverse reactions, thereby to increase the safety and quality of blood transfusion and blood products administration. Haemovigilance is an organised scheme of monitoring, identifying, reporting, investigating and analysing adverse events and reactions pertinent to transfusion and manufacturing blood products. Thus the information collected will facilitate corrective and preventive actions to minimise the potential risks associated with blood collection, processing and transfusion to patients. Indian Pharmacopoeia Commission has started a Haemovigilance Program of India (HvPI) in 2012 under its Pharmacovigilance Program of India (PvPI) in collaboration with National Institute of Biologicals (NIB), Noida, Uttar Pradesh, under Ministry of Health and Family welfare, Government of India with a primary objective to track adverse reactions/events and incidences associated with blood transfusion and blood product administration. The main objective of this article is to brief (s) about the system which monitors each and every step of transfusion reaction.</p> Sravya Sree, Pasikhanti Shailaja Copyright (c) 2019 Sravya Sree, Pasikhanti Shailaja Wed, 18 Dec 2019 07:14:40 +0000 Overview of regulations on medicines derived from traditional Pharmacopoeia in Benin and Burkina Faso <p>The success of the promotion policies of the Medicines Derived from Traditional Pharmacopoeia (MDTPs) requires a regulation that is adapted to realities and guarantees their quality, efficiency and safeness. This study aims to analyze the legal texts and the current guiding principles obtained from the heads of the departments in charge of traditional medicine in Burkina Faso and Benin.</p> <p>The documents collected from the two countries have been analyzed comparatively and also in relation to WAEMU regulations and the WHO recommendations.</p> <p>Several texts, dealing with the activity, products, facilities and advertisement related to traditional medicine, have been recorded in both countries. The regulation battery of Burkina Faso is more extensive than that of Benin, especially on traditional medicine and pharmacopoeia facilities. In addition, unlike biomedicines, the West African Economic and Monetary Union (WAEMU) and the West African Health Organization (WAHO) have not yet passed community laws on MDTPs.</p> <p>To limit disparities in legal frameworks between the countries of the same sub-region, it is important that the WAEMU or WAHO be involved in the harmonization of pharmaceutical regulations by setting Community rules in the domain.</p> Daniel Dori, Habib Ganfon, Fernand Gbaguidi, Brigitte Evrard, Joëlle Quetin-Leclercq, Rasmané Semde Copyright (c) 2019 Daniel Dori, Rasmané Semde, Habib Ganfon, Fernand Gbaguidi, Brigitte Evrard, Joëlle Quetin-Leclercq Wed, 18 Dec 2019 07:23:33 +0000 Role of ICH guidelines in registration of Pharmaceutical Products <p>&nbsp; &nbsp;The International Conference on Harmonization (ICH) of Technical Requirements is a unique project for Registration of Pharmaceutical products which are intended for human use. This brings together the regulatory authorities of Europe, Japan and United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.</p> <p>The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.</p> <p>&nbsp; &nbsp; &nbsp; &nbsp;The objective of such harmonization is a more economical use of human, animal and material resources and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy and regulatory obligations to protect public health. It creates a venue that allows all key pharmaceutical regulatory authorities and industry stakeholders the opportunity to be more actively involved in pharmaceutical harmonization work. It aimed at the standardization of requirements and format along with the content of regulatory documentation and brings down the pressure on the price of medicines by enabling greater economies of scale and a labelled regulatory playing field. This paper is an effort to provide the detailed information about ICH Guidelines.</p> Shivali Rahi, Arpana Rana Copyright (c) 2019 Shivali Rahi, Arpana Rana Wed, 18 Dec 2019 07:35:17 +0000 The need for Electronic Health Records (EHR) based Clinical Decision Support (CDS) in developing countries like India <p>Electronic health records (EHRs), an integrated approach is gaining importance not only within healthcare organizations and with their related stakeholders but also with the clinical research studies. EHR-based clinical decision support (CDS) systems in clinical studies have been proven successful in many clinical studies. The World Health Organization has emphasised the necessity to revolutionise the healthcare system in all levels, from primary health care and community service to health care research and this started with the implementation of EHR services extensively in various health care systems. Further, American and European healthcare systems are keen in improving EHR-based measurements to enable interoperability for future integrations of multiple data sources, which in turn would prove beneficial in the global platform for not only to the provider, patient, and other healthcare stakeholders but also for clinical research studies. This paper discusses the EHR in clinical research, the challenges in the EHR, and the need for developing nations to adopt and develop EHR.</p> Rengalakshmi Balasubramanian Copyright (c) 2019 Rengalakshmi Balasubramanian Wed, 18 Dec 2019 07:57:00 +0000 Good Practices in Management of deficiencies in CTD dossier and comparative study for US, EU and Australia <p>This topic aims at reviewing the drug and drug product filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for the regulation of food and drug product in Europe. TGA is the Regulatory Agency which is responsible for the regulation of therapeutic goods in Australia.</p> <p>A dossier contains detail information about the drug substance and drug product and result of studies that are carried out in development process. For getting market authorization has to be submitted to the respective regulation bodies. Due to various regulations, ICH introduced CTD for such countries that come under it. CTD is critical for dossier submission. For regulatory submission that is to be accepted in all ICH countries.</p> <p>CTD provides standardized structure. CTD makes filing easier globally. But there are differences in dossier submission requirements in these countries i.e. Module I is country specific and other regional guideline are also considered while compiling dossier application.</p> Pooja Chaudhari, Jitendra Kumar Badjatya Copyright (c) 2019 Pooja Chaudhari, Jitendra Kumar Badjatya Wed, 18 Dec 2019 08:03:04 +0000