Intellectual property rights grant the right holder a monopoly and market exclusivity for stipulated few years. However, there are few exceptions where the right holder's monopoly is eroded and a third party can utilise the innovation for one or more legal purposes that do not come within the definition of infringement. A bolar provision is one…

Drug development and approval process in Australia The Therapeutic Goods Administration (TGA), a division of the Australian Government Department of Health, is in charge of regulating the process for the development and drug approval process in Australia. Prior to the sale of medicines in Australia, pharmaceuticals and other therapeutic items must first be approved by the TGA…

Brazil is a huge pharmaceutical market that offers the pharmaceutical manufacturer fantastic potential. Registration of pharmaceuticals is a long procedure in Brazil involving various steps. In fact, it is an intricate procedure.  It is not simple for pharmaceutical manufacturers to gain access to the Brazilian Regulatory Authority's marketing of medications and biologics. The Portuguese Agencia…

Drug development and drug approval process in Europe is subject to stringent laws and guidelines to ensure that the drugs are safe, effective, and of high quality. Pharmaceuticals are evaluated and monitored in the European Union (EU) by the European Medicines Agency (EMA). To manufacture medications in Europe, a manufacturer must first get a manufacturing…

Novel and Innovative Drug Development involves several stakeholders and a talent pool from multiple and varied disciplines. It also involves partnering with various collaborators that fast-track new drug development processes and are equipped for quick turnaround timelines. It also involves discussing and seeking advice from the regulatory authorities that can help in the drug approval process. In…

What Are Reference Listed Drugs (RLDs), and Why Do They Matter? A Reference Listed Drug (RLD) is the original, approved version of a medicine that future generic versions are compared against. Think of it as the “gold standard” for generic drug makers. These branded medicines are usually the first ones launched into the market and…

The comparator sourcing market deals with exploring the availability and source of the comparator drug followed by its acquisition and supply.  The reference or comparator drugs are required in conducting clinical trial studies that compare the efficacy and safety of the test formulation or an investigational new product to those of an existing approved…

Cell and gene therapy belong to the field of biomedical research and is currently categorized as an experimental treatment.  Both these therapies are targeted to treat, prevent, or potentially cure diseases that have no other treatment available. Their use is aimed to alleviate the underlying cause of genetic diseases and acquired diseases. Both cell and gene…

Clinical trials are the backbone of the drug development program and impact the success of bringing new products to the market. Therefore, clinical trial conduct requires efficient supply-chain logistic support to manage study timelines. Risk-based optimization helps achieve efficiency, cost, and time effectiveness in this important activity. Every clinical trial requires varied supplies specific to…

Biological sample management refers to the methodical and organized processing, preservation, and disposal of products obtained from biological source and classified as biological products. It also includes biological specimens such as tissue, blood, and body fluids. Biological products deteriorate at ambient and high temperatures and lose their potency and intended pharmacological activities. In order to…