ఫార్మాస్యూటికల్ రెగ్యులేటరీ వ్యవహారాలు: ఓపెన్ యాక్సెస్

Generic drug products played an important role in the health care system in global aspects especially in the middle income country and fully developed country. They play important role in the lowering the cost of medicine and provide the low cost treatment in targeted countries. Generic drugs have the same therapeutic value same as the innovator product. This study aims to achieve the comparison of the regulation of generic drug product regulation in Zimbabwe, USA, Canada and Europe. All of the targeted countries follows the common technical document format and also focuses on safety quality and efficacy of the drug product. Regulation of generic drug in Zimbabwe is easy compared to rest of the countries.

Software is revolutionizing how doctors practice medicine, customers control their health, and patients and providers interact. Software that can perform advanced medical functions software as a medical device is a game-changing innovation in digital health technology (SaMD). SaMD may diagnose ailments, prescribe medications and offer clinical treatment recommendations. The US FDA, EU and Australia TGA also specified general platforms. To overcome the challenges while interpreting software product fits into the medical device framework, IMDRF has developed different guidance including risk based categorization to determine possible levels of premarket reviews and Real-World Evidence (RWE).) IMDRF plays a similar function in enabling the regulators to risk-stratify submissions and focus resources on products that pose the greatest risk to patient safety. While SaMD products are not new, there are many new players in the SaMD space to better regulate iterative devices. One of the key goals is to identify the excellence of the SaMD Regulatory paradigm regulation of these products will need to radically change to accommodate new SaMD manufacturers and the technology’s rapid evolution and to harness SaMD’s ability to capture RWD to create a collaborative, innovative SaMD community. This review aimed to describe the regulatory and technical aspects of the software as a medical device and regulatory transformation of digital health rapidly expanding regulations by different health authorities.