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 […]
Read More →Most of the processes to approve drugs in the EU are similar to those of the FDA, such as getting pre-authorization for use of the drug in clinical trials. After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of the drug, timeline, […]
Read More →Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers, and managers are not sure about one aspect or another on how to comprehend, act, or change their […]
Read More →Generic drug registration in Thailand can be a streamlined process, particularly if you understand the relevant regulations and requirements. Familiarity with the regulatory landscape and compliance criteria can significantly simplify the application and approval process for generic drug registration in Thailand, making it a more manageable and efficient undertaking. Thailand is the second-largest healthcare market […]
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