The conduct of clinical trials is a critical process. Along with resource hiring, it also requires materials for different activities. Some of these materials can be investigational products. But, a vast number of products could be non-investigational products necessary for the conduct of clinical trials. It becomes critical to plan for procurement or import of […]
Read More →The use of dietary supplements and nutraceutical to lower risks for illness and enhance health has gained popularity in Japan over the past few decades. The shipment value of health foods in Japan reached about 888 billion Japanese yen in the fiscal year 2021, continuing the upward trend from previous years. The market was expected […]
Read More →Oncology trials are more complex than trials in any other therapeutic area. Research in oncology differs in terms of trial design, trial types, the role of a comparator, treatment outcomes, adverse event reporting, interpreting the results, and more. Developing a well-defined clinical development strategy for oncology clinical trials is crucial due to the significant costs, […]
Read More →The European medical device market represents about 30% of the global market, after the U.S. market with a 42% share. The rising geriatric population, an increasing number of surgical procedures (especially orthopedic), and the availability of funding for research and innovation are some of the driving factors for the growth of the medical device market […]
Read More →One of the most sought-after markets for medical devices globally is the Australian market. With the regulatory reforms and increasing demand for innovative products, the Australian medical device market expectation was worth more than $4.56 billion by 2025, growing at a CAGR of 10%. In this article, we will be discussing the medical device approval […]
Read More →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 […]
Read More →The Japanese medical device market stands second after the USA. The global data expects the Japanese medical device market to grow from $54.5 billion in 2018 to $74.7 billion in 2025, at a compound annual growth rate of 4.6% (CAGR). Note: This article was updated in September, 2022. Top reasons to choose Japan for your medical device market […]
Read More →This article is a sequence of the Regulatory & Drug Approval Process in the United States, 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 market approval process of biologics, biosimilars, orphan drugs, and various drug approval pathways. Which is the regulatory authority […]
Read More →The United States represents the largest continental pharma market worldwide and holds around 45% global market. The pharmaceutical market in the United States was expected to increase from $354bn in 2015 to $497bn by 2020. The FDA is the main regulatory body that handles drug approval in the United States. Though markets like China and […]
Read More →The drug approval process in Japan is less complex and easy when compared to some other countries beyond the language barriers. In addition to regulatory considerations, the PMDA offers sponsors consultation to assist them in understanding the prerequisites and the detailed procedure for drug approval. As a result of this positive change, many manufacturers choose […]
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