A medical device is defined by Health Canada as: an instrument, apparatus, or other similar article diagnoses, treats, mitigates, or prevents conditions and diseases in human beings, prevents conception, cares for humans at or after birth, diagnoses pregnancy or restores, modifies, or corrects body structure Some examples of medical devices include pacemakers, cardiovascular stents, respiratory ventilators, or even small items like tongue depressors or bandages. With new regulations coming into play later in 2019, read on for how this could affect regulatory affairs! What Are some Medical Device Safety Issues? Unfortunately some medical device issues can arise, which has led.. READ MORE »
The United States-Mexico-Canada Agreement (USMCA) is a free trade deal recently signed between North America’s three largest countries. Once ratified, it will replace the North American Free Trade Agreement (NAFTA) and it has major implications for the pharmaceutical industry, especially in terms of intellectual property rights. In its current form, the USMCA could significantly change how pharmaceutical companies sell their products in Canada. Here’s what you need to know about the USMCA if you’re studying regulatory affairs. The USMCA Will Extend Patent Protections for Biologics to 10 Years The USMCA will extend the patent protection period for biologics—which are pharmaceutical.. READ MORE »
The review of prescription and non-prescription drugs authorized is a long and intricate process, from research and development to clinical trial to ending up on the shelves of local pharmacies. Often, due to a variety of reasons, many drugs do not make it to market, and fail to be approved for public use. Here are some aspects of the regulatory process students interested in regulatory affairs should know. Therapeutic Value and Product Effectiveness The effectiveness of a drug allows it to pass clinical trials. Its success relies upon its therapeutic value, or how efficient the drug is at treating the.. READ MORE »
High sanitation standards are required during drug manufacturing, and regulatory affairs workers pay close attention to these Health Canada guidelines.
In hospitals and doctors’ offices, drugs aren’t the only things responsible for helping patients heal and feel better. Medical devices are a huge category of medical care tools that often go unnoticed, but are crucial to modern day medicine. Medical devices include wheelchairs, medical scissors, and even bandages. They can range from low-tech to high-tech devices and can even include pacemakers. Some of the technologies used to produce them include microelectronics, biotechnology, and even software. Unlike drugs, which dissolve and are absorbed by the body, medical devices are instruments, tools, and implants that can help with everything from diagnosing a.. READ MORE »
Regulatory affairs is a relatively new and demanding career. It requires extensive knowledge of the business, legal, and pharmaceutical aspects of products in development, so that projects can be operated smoothly from inception to market. A regulatory affairs specialist is responsible for keeping up-to-date with all of the rules and regulations that govern the production process for new drugs, cosmetics, and other medical products. And while it is an incredibly rewarding career both emotionally and financially, there are some specific skills that can help you succeed in this profession. If you’re interested in a career that encompasses the specifics of.. READ MORE »
Today’s pharmaceutical industry is very much a global market. While traditional economic powers like the United States remain leaders in the field, new drug development, manufacturing, and trade is now taking place in increasingly diverse parts of the world. In fact, the emerging markets China and Brazil are now home to the 3rd and 6th largest pharmaceutical industries in the world. Not only that, but companies are now manufacturing and developing drugs for distribution to a variety of different countries, each with their own regulations and guidelines. As a result, professionals in the regulatory affairs industry now face a tougher.. READ MORE »
Many pharmaceutical products developed and manufactured in Canada are exported to the United States. As a result, while Canadian regulatory affairs professionals answer primarily to Health Canada, they must also pay special attention to the department’s U.S. equivalent, the Food and Drug Administration (FDA). The FDA officially came into being in 1906, after the Food and Drug Act was signed into law, with the aim of overseeing products and ensuring a high standard of “strength, quality and purity.” Over the years, the department’s powers have expanded significantly, and today the FDA regulates everything from food and drug products to potentially.. READ MORE »
Drug research is essential to helping medicine advance and finding new ways of fighting illness, but it is a long and complicated process. Just one in every 5,000 compounds that enters preclinical testing actually make it to the marketplace, and companies spend approximately US$500 million per product, with studies taking anywhere from 8 to 15 years. For regulatory affairs professionals involved in new drug development, the barriers to making potentially beneficial products available to the public can sometimes be frustrating. Nevertheless, the regulations are necessary to ensure that drugs are safe and effective. So how does a new drug get.. READ MORE »
