Regulatory Requirements Of The Pharmaceutical Industry Us, Eu, And Japan All Have Their Own Regulatory Control

U.S. based companies hold rights to most of the world’s rights on new medicines and holds thousands of new products currently being developed. As of 2012, the industry helps support almost 3.4 million jobs in the U.S. economy. It is also one of the most heavily R&D based industries in the world. In the United States, the environment for pharmaceuticals is much friendlier than other countries around the world in terms of pricing ability and regulations. Both the Pharmaceutical and Biotechnology industries have experienced significant growth in the past year with year-over-year increases of 13.02% and 34.69% respectively. It is an even more striking when looking at the past five years considering both have beat out the S&P 500 with pharmaceuticals increasing an additional 31.44% and the biotechnology sector besting an astonishing 269.3% more return than the

Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

The National Collegiate Athletic Association (NCAA) is a very powerful organization in the United States. The NCAA at the end of 2007 approximately earned $627M a near one billion dollars. The NCAA oversees nearly every aspect of the $11 billion college sports industry. The NCAA tries to help and make college athletics fair but they simply have too much power.

The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses

In the novel To Kill a Mocking Bird by Harper Lee, Atticus Finch is the father of two main characters Jem and Scout. Atticus is a respected lawyer in Maycomb County. Atticus treats everyone the same, no matter man, woman, white, or black. This novel portrays Atticus as a wise, calm, and kind. This gives him the respect that he deserves from Maycomb County.

There are a number of challenges in for setting up clinical trials and performing biopharmaceutical development. In fact, China has the longest drug application timeline of all Asian countries. Language , culture, infrastructure, regulatory and quality issues are some other challenges in the emerging economies

The cost of new medical drugs seems to be accepted by many people who use them. These pharmaceutical companies increase their profits more and more each year because many people assume that it does cost a lot of money for research and development. Where in reality, they are only spending about 15% of their profit margins on research and development alone. A huge percentage of these drugs are actually tested in other countries where people are more willing to do trials with these drugs because they cannot afford them. Not only are there more people who are more willing to try them, but also there is less regulation and oversight when it comes to testing. Conducting these clinical trials overseas not only saves

This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug.

Biotech companies’ values are primarily driven by intellectual property, they do not need to rely much on their suppliers. These companies also have relatively easy access to sources of raw materials (such as chemicals), scientific tools, computers and testing equipment.

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

Economic: Globalization of the pharmaceutical industry is an exciting opportunity to have research and development done at cheaper prices in other countries. However, this could be a double edged sword for companies because it is easy for other countries, such as India, to produce generic versions of the drug in bulk.

The Food and Drug Administration has proposed and created several regulations throughout the years. One of them is the regulation to establish a list of qualifying pathogens that may have the potential to propose or cause a great threat. According to the FDA, this proposed rule would implement a provision of the Generating Antibiotic Incentives Now of the FDA. This regulation would assist in reassuring the development of new antibacterial and antifungal drugs. Before the development of new drugs, the FDA must take into consideration the effect on public health due to drug- resistant organisms in humans. The purpose of this paper will be to discuss and highlight what this regulation truly means and the issues surrounding it.

The research and development of the pharmaceutical industry is very important as the industry relies on it to develop new products to maintain and sustain the growth of the industry (ALRC 2014). According to the Australian Government Law Reform Commission, every year, the total spending in research and development in pharmaceutical industry, which includes drug discovery, pre-clinical testing and clinical trials on drugs is around $300 million (ALRC 2014). Mergers and acquisitions are intensifying in the global pharmaceutical industry, especially over the last 10 years. With factors like exorbitant research and development costs, the relatively shorter product life cycles, and the rarity of discovering a new life-changing drug acting as catalysts, leading pharmaceutical companies now have more cause to step out and look for external collaboration. This results in an increasing number of smaller biotechnology companies merging with bigger pharmaceutical companies (The

Nowadays, Asian food plays an essential role in business, because the concept of it is to recreate the tastes of Asia in a casual and relaxed atmosphere and to provide people with tasty and healthy eating at a reasonable price, especially the shop located at Chinatown named ‘Green Noodles’. ‘Green Noodles’ is spreading its tastes of Asia across the country with brand awareness stores in South Australia, Western Australia and Queensland. The campaigns have been focus on positioning our brand as fresh Asian fast food dining and promoting other brand characteristics such as tasty, safe and genuine etc. Some people may think Asian food is tasty and healthy while other people hold the idea of Asian food may contain too much oil