Medicines – from idea to market

Every year, countless new medicines are developed in the European Union. Of course they have to undergo a long and scrupulous process before they can be made available to patients. Let’s have a look at the journey a medicine makes from the initial idea until it is brought to market.

The first step is research and development. Researchers start by evaluating the potential medicine in the laboratory, to see if it may work as a treatment. After that, the substance is evaluated in humans. First in a small group of healthy volunteers, to see if it is safe to use, and then in bigger groups to assess effectiveness and side effects and to compare the medicine to existing treatments for the same  disease or condition. During this phase, the researchers can ask EMA for scientific advice, for example on the optimal design for the study or the methods to be used. This guidance helps researchers to deliver the necessary data for EMA to assess their application in the most efficient way.

Once the clinical studies have been completed and the investigational medicine has proven effective, the manufacturer (for example a pharmaceutical company) submits an application for marketing authorisation to EMA. This application includes all the data collected about the medicine, such as the results of the studies performed, a risk management plan and the information that will be provided to patients and healthcare providers. The EMA evaluates all the information in a process that takes up to 210 active days, with one or two breaks where the applicant has to answer any questions the EMA task force may have. Based on all the information provided, the EMA issues a recommendation whether or not the medicine should receive marketing authorisation.

The actual authorisation is then granted by the European Commission, based on EMA’s recommendation. The authorisation is valid for all of the EU countries. Once the marketing authorisation has been granted, the medicine can be brought to market in all EU countries; it is then up to the manufacturer to decide in which countries it will be available. This procedure is called the centralised procedure and is used for most new medicines. Most generic and over-the-counter medicines are authorised at national level.

Once the medicine has been put on the market, its safety and performance are monitored based on clinical experiences. That way, action can be taken if there are concerns about the safety or benefit of the medicine.

Each of these steps contributes to the availability of safe and effective medicines in the European Union. At MTEC, we love to contribute to this process by providing meticulous translations of the documentation that is necessary for each step.