The pharmaceutical industry is one of the sectors that grows year after year globally. Although it is an essential industry to maintain the health of the population, a right to which every human being has, it is also an industry like any other that has the right to obtain economic benefits, which allow it to continue working on the development of new therapies.
The increase in the population and its aging have led governments to increase health expenditures, which have an impact on the State budget.
This has led them to put pressure on the pharmaceutical industry, forcing it to reduce its manufacturing costs in order to have cheaper medicines and thus facilitate access to medicines for the population.
The expiration of patents has brought about the rise of the generic market, which has generated that the sale of medicines is a race against time, causing pharmaceutical companies to pressure the health authority to obtain marketing authorizations for their medications as quickly as possible.
And in cases where drugs have already entered the market, but must go through a process of change, companies also require expedited authorizations from the health authority so as not to fall into shortages, for the benefit of patients, but also for not lose your captive market to the strong competition that exists today.
Much is said about the times that the health authority takes to issue an authorization, but it is the same industry that many times is unaware or forgets to also consider the time that it itself needs to contribute so that health authorizations can be granted in the time in the one that requires it.
In order to obtain a marketing authorization (health registration) or a change authorization (modification of the registration conditions) without receiving a request for additional information or clarification from the health authority (prevention letter).
It must be ensured that the file to be submitted contains all the documents, legal and technical, required by current health regulations.
Without a qualified healthcare regulatory affairs department, the company has no opportunity to obtain the corresponding sanitary authorizations in a timely manner, all this explains that it is the right time to go for pharma regulatory affairs course in USA.
The industry must always generate and provide the information that ensures that a new drug is effective and safe, or that in case a change has been necessary in a drug that is already on the market, the information that demonstrates that it retains the same efficacy and safety characteristics as when the health registration was granted, despite the changes to which the product must be subjected.
And it is essential that you take into account that the preparation and review of a complete file takes a considerable time, which must be added to the time that the authority needs to review it meticulously, and the time it takes for its administrative process to issue the corresponding authorization.
The responsibility for obtaining these sanitary authorizations falls on the personnel of the healthcare regulatory affairs department having studied pharmaceutical regulatory affairs course in USA.