Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 6, Issue 3, 2019

Background: Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new medical devices for the treatment and diagnostic of several diseases. New innovation in industries and regulations work together to provide devices for different world market and to improve quality and safety of exiting devices in the market. The main key for devices is to classify the determination of actual regulatory pathway which ensures the safety standards and other regulatory requirements in a specific country. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. For any high-risk devices, the new EU law states that the manufacturer has to prepare a complete summary for their evidence. The clinical trials regulation provides more transparency on clinical trials data. Complete transparency is required for the maximum possibility of informed decisions in order to use new medical devices. Objective: The current manuscript will provide the information regarding the regulatory framework for the approval of medical devices and clinical investigation of medical device in European Union and comparison of approval process of medical device in USA, EU and India. The aim of this paper is to provide an overview of the most suitable and emerging requirements that manufacturers need for introducing their medical devices in the market in compliance with the MDR regulations. Conclusion: The proposal for a modified regulation of medical devices aims to ensure more robust clinical data in support of the CE marking applications of the medical device. The clinical investigation requirements will be mandatory, and there will be an obligation to demonstrate the clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on comparison devices. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.

Objective: To present an overview of import need for wound care and burn dressings in India. This article provides a complete analysis of the import-export value of wound care and burn dressings in India. It helps in preparing growth strategies, knowledge about leading players, recent developments, business strategies, and manufacturing status of the wound care and burn dressings in India. Methods: A trend analysis of import-export was carried out for wound and burn dressings in India. Raw data of the years (2008-2017) were collected from various market research analysis sites and import need was identified. Results and Discussion: The detailed analysis reveals that India is a growing market for wound and burn dressings and spends a lot of the exchequer on importing the subject commodity. Wound dressing export is averaged to the same from 2013 to 2017. India saw a rise in wound dressing export after 2012. India saw a rise of wound dressing import over the past 10 years. It averaged 502.6 million from 2008 to 2017 and it reached its all-time high of 765 million in 2016. The import value was found quite high as compared to export. Conclusion: The report of import and export analysis very clearly highlights that there is a strong demand for dressings in the country and due to lack of own manufacturers of such dressing in India, these are imported. Since these products are expensive, there is a large outflow of Indian currency due to imports. It is imperative that such products get government attention and should be manufactured within the country.

Background: Biological products comprise the most complex and diverse types of drugs that are made by living cells. The use of biological products has increased significantly in recent decades and has contributed significantly to improving the efficacy of treatment in many diseases. Patent protection for pharmaceutical products, including biological products, generally expires about 20 years after development. Expiration of patents of biological innovative medicines allows regulatory authorities to approve copies of biological medicines, such as medicines called similar biological products (biosimilar) and to enter in clinical use. Biosimilar products are comparable but not identical with innovator biological products and are not a generic version of the innovator biological product. While biosimilars are subjected to rigorous characterization and clinical trials to demonstrate their safety and efficacy, in the case of biosimilars certain regulatory requirements apply for registration. Biosimilars are very complex and large molecules and minor changes in the manufacturing process can have important implications in their safety and efficacy profiles. To ensure that biosimilar reaches their potential in clinical application, intensive Pharmacovigilance system and risk management plan must be established to demonstrate the true similarity between the biosimilar products and original biological products. Biosimilars are part of the growing sector of the pharmaceutical industry and normally used by human beings since manufacturers of biosimilars face some challenges in regulatory approval and manufacturing of biosimilars in the European Union. Objectives: The current manuscript will provide the information regarding the regulation of biosimilar products with guidelines and challenges faced by manufacturers during approved and manufacturing of biosimilar products in the European Union. This manuscript also provides the status of approved and rejected biosimilars by EMA (European Medicine Agency). Conclusion: Biosimilars may reduce costs when patent protection of biological products expires and compared to the original products, savings are not as large as seen with traditional generics. In the coming years, there will be an increasing number of biological and biosimilar products available on the market, highlighting the need for specific short and long term post-marketing surveillance programs for these medicines. It is essential to understand how the concept of compatibility, interchangeability will be managed and regulated in the future. An important aspect for future a high quality, clinical and non-clinical studies will be conducted to evaluate the safety and efficacy of biosimilars. Scientific guidelines on biosimilar issued by the EMA (European Medicine Agency) that established a process to demonstrate the similarity between a biosimilar product and the innovator reference product.

Objective: Medical device acceptance of patients has grown considerably in recent years. This has question the effectiveness of the current regulatory frameworks to ensure the performance, safety, and quality of new devices. This article focuses on the methodical overview on hip and knee joint replacement medical devices evaluating the procedure and proper analysis of medical device regulation in three jurisdictions i.e. the United States of America (USA), EUROPE and INDIA, exploring reforms been laid to stabilize and meet the requirements of existing systems, and further analyse the additional actions which should be employed to fully meet this ultimate goal. Methods: We analysed the hip and knee joint replacement medical device regulation system through a secondary research in United States, Europe and India in compliance with the updated national regulatory authority’s legislative documents and requirements. Results: These three regulatory systems vary in their working, organization, acceptance for their specific pre- and post-market evidence requirements, and transparency of process. The most challenging factor remains the same for the countries which are to make sure safety and effectiveness of devices, proper monitoring of its use and important compliance information readiness employing quality management system towards new findings and acceptance for the users. A case study of Johnson & Johnson ASR Implant was also studied, highlighting the major reforms required and the reforms introduced in the United States, Europe and India. Thus, quality and safety reforms are made to strengthen the premarket compliance requirements, enhancing the need of post-market regulation through proper traceability and monitoring of devices by employing the functioning medical device registry. Conclusion: Recent reforms address the major challenges in device regulation, highlighting the need to create connecting points between the device identifier system and existing data collection tools, such as electronic health records, and maintaining effective and up to date use of registries to ensure post-market use of new and existing devices.

Background: In today’s era, various health boosting products viz. probiotics, functional foods, dietary supplements and nutraceuticals are gaining great commercial interest. Although probiotics have traditional history of their use, their regulatory approval regimes across the globe are complicated and incoherent. Objective: The present article has been compiled to give an overview of the existing approval guidelines for the probiotic products across the globe along with their associated ambiguities. Furthermore, suggestive consolidations for harmonized approval process to be implemented in future are proposed on the basis of their intended use. Methods: The study was carried out by using secondary sources through literature survey from journals, market reports, proceedings, books and web pages of relevant regulatory authorities and a critical comparative study was conducted with respect to approval process of probiotics. Results: As per the comparative account of the current regulatory guidelines, it has been evidenced that different countries have adopted diverse approval process for probiotics and; lack of uniformity is of great concern. But due to rapid emergence of probiotics as drugs, a harmonized approval process similar to other drugs covering all aspects of Investigational New Drug Application (INDA) and New Drug Application (NDA) has been proposed in which organisms falling under Generally Recognized As Safe (GRAS) category are exempted from INDA submission whereas non GRAS, GRAE or new organisms are not exempted. After submission of NDA and getting approval from Food and Drug Administration (FDA), product should be manufactured and marketed. Conclusion: Regulatory bodies across the globe must ensure that probiotics based products should be regulated by lawful approval process in such a manner which will lead to maximal health benefits and minimal health risk for consumers.