Every discovery in the lab that shapes to be a drug takes various modes over several years before it appears from a lab to the medicine cabinet. A drug that is finally converted into a medicinal product is intended to address a particular ailment. In fact, a medicinal product is expected to either, prevent, treat, diagnose…

Are you wondering what to do with the expired and unused medicines lying in your medicine box? If you are throwing them in a normal household dustbin, please refrain. How to discard unused prescription medicines that have crossed the expiry date? Most of our households have unused and expired medicines at home and usually wonder what…

Intellectual property law grants patent holders a period of market exclusivity, typically 20 years, during which no one else can manufacture, use, or sell the patented invention. But this exclusivity isn't absolute. Several narrow exceptions exist, and one of the most consequential for the pharmaceutical industry is the Bolar provision. Concisely, the Bolar provision (also…

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…

Comparator drug sourcing plays a critical role in the clinical trial ecosystem. It involves identifying, acquiring, and supplying approved reference drugs—commonly referred to as comparator drugs—that are essential for comparing the efficacy and safety of new investigational products. These comparator drugs serve as the benchmark in clinical trials, allowing researchers to draw reliable comparisons between…

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…