This article is a sequence of Drugs: Regulatory Approval 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 marketing approval process of Biologics, Biosimilars, Orphan drugs, and various approval pathways. What is the regulatory for biologics […]

Read More →

Japan’s pharmaceutical market is one of the largest in the world, with figures from the Ministry of Health, Labour and Welfare (MHLW) indicating a market value of about $95 billion, including non-prescription medications. Analysis of various show that the country’s market for drugs will continue to grow, driven by a range of factors, for example, […]

Read More →

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 […]

Read More →

Most of the companies are spending a significant amount of cost and manpower to manage clinical trial activities as database building, monitoring and management of data using a variety of EDC systems as Inform, Rave, Oracle Clinical Remote Data Capture, Veracity, etc. Many software, web-based applications, and cloud source management tools are being used in […]

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 →

Learning about global regulatory requirements and understanding the pathway for approval can help clinical development teams take their global strategy in the right direction. Sharing expertise from regulatory experts for those who need it. (This article was originally published on LinkedIn). It’s no news that we are now living in an era with tremendous surge of […]

Read More →

Rare disease drug development is gaining interest in pharma industries. Large pharmaceutical companies have been working for many years, and now startups, small and mid-range pharma companies are also gaining traction in rare diseases drug development.  Developing medicines or drug products in rare diseases is always challenging for both the scientific and clinical development team […]

Read More →

Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent comprised of clinical segment, the global CRO market was estimated at $31.6 billion in 2018 and is expected to grow at a CAGR of 12 percent to reach $45.2 billion by 2022 according to a report. Contract research organizations (CRO)’s are the companies […]

Read More →

Australian regulators do not distinguish between medicines and complementary medicines when it comes to safety, efficacy and quality of the product, including the imported products! Read the first part of this series – Regulatory Approval for Complementary Medicines in Australia Part-I – to understand what complementary medicines are and how they are classified in Australia. To […]

Read More →

Do you know any product segment, where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of Chinese government for the past several decades to dominate various industrial sectors, including pharmaceuticals. While, China has been the big production factory for generic drugs and API ingredients for many years, […]

Read More →