Clinical Trial Drugs Regulations and Manufacture - Thesis Example

For quite some time, clinical trials in the pharmaceutical industry have been regulated by several government bodies. These regulations are set forth by entities like the United States Food and Drug Administration (FDA), the European Medicines Agency (EMEA or EMA), the International Conference on Harmonization (ICH), and the Medicines and Healthcare products Regulatory Agency (MHRA), to name a few. These entities weigh heavy collateral on how pharmaceutical companies transition medicines from ideal to market with the use of clinical drug trials.

The severity of the clinical trial drugs process has a significant donation to the well being of humanity, but faults in the production of medications that will suffice in the treatment of those it was produced to treat. James Bryce once said;In short drugs, trials are performed to adhere to safety regulations that conform to human health strategies. According to the United States National Institutes of Health Service clinical trials are “considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol” (Understanding Clinical Trials, 2007).

In order to associate the importance of these trials, it has to be first comprehended as to where they have evolved from. Traditionally, clinical drug trials can be associated with pharmaceutical medicine. The history of pharmaceutical medicine can be accredited by sixteen distinct contributions as directly cited by the Drug Study Institute (Saponaro, 2011):1. In 1906 the Pure Food and Drug Act was passed, partly due to Dr. Wileys Poison Squad experiments. It forbade interstate and foreign commerce of adulterated and misbranded food and drugs.

There were no safety or efficacy requirements. In 1902 Dr. Wiley started research with human volunteers to determine the effects of food preservatives on digestion and health. Overnight the press made the "Poison Squad" a national sensation. This law required new drugs to be tested for safety before marketing, the results of which would be submitted to the FDA in an NDA or New Drug Application. The law also required that drugs met standards of strength and purity and had adequate labeling for safe use.2. The Elixir Sulfanilamide tragedy in 1937 prompted Congress to pass the Food, Drug, and Cosmetic Act in 1938, which required pre-market review of safety in a New Drug Application (NDA) and specified labeling requirements.

It also began marking study drugs with the phrase, “for investigational use.” It also gave the FDA the authority to inspect sponsor drug manufacturing plants and gave them more enforcement power. The requirement of proving effectiveness was still missing.