The United States remains the largest medical device market in the world with $156 billion which is 40 percent of the global medical device market in 2017 and By 2023, it is expected to grow to $208 billion The medical technology industry (commonly referred to as medical devices) consists of articles, instruments, apparatuses, or machines […]

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Do you have scientifically proven evidence that the country you have chosen is a perfect destination to conduct your clinical trial? Does the country you have chosen provide all the resources for conducting your clinical trials?  Have you compared it with other eligible regions? The US and most Western European countries remain the important centers […]

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Japan stands as the world’s second-biggest medical device market, after the US. The Japanese medical device market is expected to reach from $54.5 billion in 2018 to $74.7 billion in 2025, growing at a compound annual growth rate (CAGR) of 4.6% according to GlobalData, The rapidly aging Japanese population, an increasing number of patients with […]

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This article is a sequence of United States: Drug Approval Regulatory Process Part-I which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the marketing approval process of Biologics, Biosimilars, Orphan drugs, and various approval pathways. Which is the regulatory authority for biologics […]

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The U.S. represents the largest continental pharma market worldwide and holds around 45% of the global market The US pharmaceutical market is projected to increase from $354bn in 2015 to $497bn by 2020, according to a report. Though markets like china and Indian have shown a great leap in the pharma market, the United States […]

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Any clinical research professionals and staff members say that one of their biggest challenges when conducting a clinical trial is, obtaining a sufficient number of participants.  If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study timeline, increasing resource usage and costs. A […]

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In recent years there is a huge leap of pharma industry towards rare diseases and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines, supportive regulatory frameworks, financial incentives, and many more. Currently, large pharmaceutical companies are extremely active in the orphan drugs market. Novartis, GSK, Roche, and […]

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In a way to support and encourage pharma companies to work upon developing drugs or medical devices in rare disease, several country regulatory agencies are coming up with various benefits such as faster approvals, fee concessions and financial benefits etc. These countries include the US, Europe, Japan, Australia, South Korea and most recently, India. Incentives […]

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Financial benefits, faster approvals, and less stringent clinical data requirements are some important benefits that regulatory agencies across the world offer as incentives for the development of orphan drugs for rare diseases. These countries include the US, Europe, Japan, Australia, South Korea, Brazil, and most recently, India. These incentives have been so supportive and convincingly […]

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Clinical supply chain teams manage some typical challenges almost every day of their work in handling clinical trial logistics for local or global clinical trials. These include those related to regulatory compliance, temperature control (or, excursions), labeling, actual shipment or last mile delivery. These challenges are often compounded multi-fold when clinical trials relate to a […]

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