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

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.

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.

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.

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

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

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.

The U.S. Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services that is responsible for assuring the safety, efficiency, and quality of drugs and vaccines. In America a drug must first be evaluated by the Center for Drug Evaluation and Research (CDER), which is a division of the FDA, before it gets approved for sale. This means that the department must make sure that the medicine been evaluated works properly and that its health benefits are greater than its identified risks. A company or a sponsor that is introducing the new drug initially performs a laboratory and animal tests to determine the safety and the effectiveness of the drug in humans. Once this step is successfully completed, several tests are implemented in people to confirm that the drug is safe when used to treat a disease and whether it provides a real health benefit. Finally, results of the tests that prove the safety and the effectiveness of the treatment are sent to the CDER. After a group of experts at CDER reviews the submitted evidence and ensures that the medicine's health benefits surpass its known risks, the drug can then be sold around the US (Development & Approval Process (Drugs), 2014).

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 regulatory strategic plan is a key to the development of a medicinal product. During drug development, the regulatory strategy is one of the most critical factors for the successful approval of the medicinal product. In addition, the regulatory strategy plan can optimize labeling across several counties in order to maximize market success. The purpose of this regulatory strategy plan is to establish a good understanding of the preclinical, clinical and marketing application regulatory requirements for the development of a biosimilar of Rituximab in the United States, Canada, France and India.

In the United States, both U.S. Patent Law and U.S. “ Food and Drug Administration” (FDA) law govern the exclusivity rights for new pharmaceutical products. As Chinese companies invest research time and money in developing new drugs, it is important to keep in mind both the relevant U.S. patent law and the applicable FDA law that could affect the exclusivity period for that drug in the United States. Mistakes in not obtaining proper patent coverage or satisfying the FDA laws could cost the drug company valuable exclusivity rights when that drug is sold in the United States. For a successful drug, the lost of exclusivity rights usually means the loss of substantial revenue and profit.

The Pfizer case provides an introduction to external analysis. The case highlights the pharmaceutical industry, which has enjoyed extraordinary long-run profitability. The case also demonstrates how broad changes in broad environmental factors (i.e. demographics, technology, culture, etc.) have an impact on industry competition. The case is not especially complex, so it is not overwhelming as a first case.

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

Therefore, protection of patents is one of the key conditions necessary for further development of the pharmaceutical industry. At the same time, non-efficient legislation that does not provide the necessary level of patent protection is one of the factors that hamper expansion of “Big Pharmaceutical” companies to the developing countries8.

This report provides an analytical strategic review of the global pharmaceutical industry; its origin, evolution,

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