The pharmaceutical industry is one of the sectors that grow year after year globally. Although it is an indispensable industry to maintain the health of the population, the 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 population and its aging have led governments to an increase in health expenditures, which have an impact on the state budget; this has led them to put pressure on the Regulatory affairs services, forcing it to reduce its manufacturing costs in order to have cheaper medicines and thus facilitate the population’s access to medicines.
The expiration of patents has resulted in the rise of the generic market, which has led to the sale of medicines being a race against time, causing pharmaceutical companies to press the health authority to obtain authorizations for marketing their products. Medications as quickly as possible. And in the cases in which the medicines have already entered the market, but they must go through a process of change, the companies also demand from the health authority expedited authorizations not to fall short, for the benefit of the patients, but also to do not lose your captive market to the competition so strong that it currently exists.
There is much talk about the times that the health authority takes to issue an authorization, but it is the same industry that often does not know or forgets to also consider the time it needs to contribute to sanitary authorizations can be granted in time in He who requires it.
In order to obtain a marketing authorization (sanitary registration) or a change authorization (modification of the registration conditions) without receiving a request for additional information or clarification from the health authority (prevention office), it must be ensured that the file to be submitted contains all the documents, legal and technical, required by current health regulations.
The industry should always generate and provide information that ensures that a new drug is effective and safe, or that in the event that a change in a drug that is already on the market has been necessary, the information proving that it retains the same characteristics of efficacy and safety of when the sanitary registration was granted in spite of the changes to which the product must be submitted. And you must take into account that the preparation and review of a complete file take considerable time, which must be added to the time that the authority needs to review it thoroughly, and the time it takes for your administrative process to issue the corresponding authorization.
Why consider the Regulatory Affairs department as a key piece in the pharmaceutical industry?
Because it is the “beginning of the chain” of marketing; without authorization from the health authority, it is not possible to market a medicine, and without a qualified Regulatory Affairs Department, the company has no opportunity to obtain the corresponding sanitary authorizations on time. The staff of the Department of regulatory consulting must review all the documentation to be submitted to the authority to prevent it from requiring additional information or clarification.