The pharmaceutical industry is a particularly vibrant, constantly evolving sector where innovations, new procedures, and of course, new drugs emerge continuously. Pharmaceutical wholesale is a huge business, now managed on a global scale. Pharmaceutical registration is a rigorous process aimed at determining the reliability of the examined medication. This is particularly important as patients are unable to assess the quality of a drug before using it. What exactly does the registration process entail, and what types of it exist? We explored this in detail in this blog post!
In Hungary, pharmaceutical registration was introduced as early as 1933, making it one of the first in Europe. This procedure falls within the realm of public administrative proceedings, and during the process, the National Institute of Pharmacy and Nutrition (NIPN or NNGYK in Hungarian) handles the registration of drugs and issues marketing authorizations. With this authorization in hand, the drug can enter the market; prior to this, it is considered an investigational product.
The purpose of pharmaceutical registration is to guarantee its reliability to the regulatory authorities. In practice, this entails consistently maintaining a high level of quality, ensuring safety, and delivering effectiveness. And importantly, these can be proved with rigorous documentation.
The process of pharmaceutical registration in Hungary
The pharmaceutical registration process is a crucial and decisive stage in the research and development process. There are four fundamental procedures through which a drug can officially enter the market. These procedures are essential in terms of efficacy, safety, quality, and patient perspective. Let's see what these are and how they work!
Centralized/EMA registrations
In the centralized procedure, the European Medicines Agency (EMA) evaluates the application for the drug. This route is typically chosen for drugs containing new active substances or for the treatment of severe diseases. A positive opinion from the EMA leads to a marketing authorization valid throughout Europe. This process streamlines the rigorous evaluation of packaging, strength, safety, quality, and efficacy. Its advantage lies in the fact that the product evaluation is carried out only once, and the pharmaceutical registration will be valid in all EU countries.
Mutual recognition procedure
In the mutual recognition procedure, a manufacturer selects the authority of a chosen country to evaluate the drug. This procedure can be shortened for manufacturers since it is not necessary to initiate a separate pharmaceutical registration in each country; other countries can complete the approval process through an expedited procedure. From the patients’ perspective, this means that the drug can become available in their countries sooner.
Decentralized registration
In the decentralized procedure, the manufacturer simultaneously submits the pharmaceutical registration application to several EU member states if the product does not yet have marketing authorization in any country. This method allows the involved countries to conduct the necessary evaluations concurrently, thereby accelerating the entry of new drugs into the market
National registration
There are cases when the manufacturer of a drug intends to introduce their product only to the market of a specific country. In such instances, the national registration procedure is employed, during which the health authorities of the particular country evaluate the application according to their national pharmaceutical regulations. Safety, quality, and efficacy remain fundamental considerations in this process as well.
Each pharmaceutical registration procedure has its own advantages and challenges, but their goal is common: to ensure that only safe, high-quality, and effective medications reach patients. Thanks to stringent pharmaceutical regulations, patients can be assured that the medications they receive comply with the strictest international standards.
Among these procedures, we can choose from various pharmaceutical registration strategies. To make the appropriate selection, factors such as the active ingredient, the nature of the manufacturing company, the countries of distribution, professional competence, human resources, financial capabilities, patent situation, and the likelihood of market entry need to be considered.
With more than 30 years of professional experience, Inthera provides support to clients in the pharmaceutical regulatory. We offer comprehensive services throughout the European Union during the pharmaceutical registration procedures. Discover our services and reach out for our assistance in your pharmaceutical regulatory affairs!