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The Key Processes and Issues in the Stages of Obtaining a License for the Supply of Medicines - Essay Example

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The writer of this paper states that trialing a new drug is a human experiment, and drug development is a long and costly process fraught with tribulation. The tortuous pathway traveled by a new drug from synthesis…
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The Key Processes and Issues in the Stages of Obtaining a License for the Supply of Medicines
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Download file to see previous pages Most importantly, it is a process involving the constant percolation of data through rigorous filters strewn with tribulations and complicated by the difficulty of making decisions that affect human health when all the facts are not known.
Overview: The process of phases I to IV clinical trials is the cornerstone of the drug registration and regulation process. Most countries require evidence of efficacy and safety for licensing new drugs. The implications of such a process are significant. Research discoveries whether it is publicly funded or funded by commercial organizations must be transferred to companies so that they can be developed into a commercial product to allow people to have benefit. This benefit should come after ensuring the safety of the population. The licensing system is utilized for ascertaining the regulation of the new drug while performing the trial (Cartwright AC, Matthews BR, 1994).

Prelicensing System: This indicates that the authorities believe and acknowledge the fact that before a drug is manufactured even for trial, a favorable balance between the beneficial and harmful effects would need to be demonstrated. Therefore, the regulatory system should provide timely access to effective treatment, protect patient safety, and foster research into new treatments (NIH Data Book 1994). The respective agencies protect public health by ensuring that only products with favorable benefits to risk profiles are licensed. It also means that since the authority is required to foster research, at the same time, the authority should not create unnecessary regulatory impediments, especially in relation to licensing. Putting it straight, innovative medications, if they are promising would need to move in the fast track out of the red tape so that benefits are available to the people quickly (NIH Data Book 1994).
Product Assessment: All medicinal products need to be licensed before they can be marketed unless they meet one of a small number of exemptions. ...Download file to see next pagesRead More
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