Rare diseases, also known as orphan diseases, are medical ailments that impact fewer people in the community compared to other prevalent illnesses that are often encountered in the population. Due to rare occurrences rare diseases are defined with respect to the prevalence found in the population and varies in the various geographic areas.  In the…

Duplicate or fake medicines are called Counterfeits. Counterfeit medicines are purposely misrepresented in terms of their identification, source, or legitimacy. These duplicate medicinal products are manufactured and distributed on purpose to fool consumers by imitating real and genuine medical products.  Both emerging and developed nations are home to fake medicines, that includes prescription drugs, over-the-counter drugs, and…

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 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…