How long does it take for a new medication to become available on the market?
January 10, 2022 | 20,00 EUR | answered by Jan Voigt
Dear Doctor,
my name is Ulrike Büchner and I have been suffering from a chronic illness for some time now, for which there is currently no effective treatment. I have heard that there are constant advancements in medicine and new medications are being developed. Therefore, I wonder how long it usually takes for a new medication to come to market and be available for patients like me.
I am concerned that I may have to wait a long time for a suitable treatment and continue to suffer from the symptoms of my illness in the meantime. Therefore, it would be very helpful for me to know what steps and processes need to be completed before a new medication is approved and can be prescribed by doctors.
Could you please explain to me how long it usually takes from the beginning of development to the market launch of a new medication? Are there ways to speed up or shorten this process so that patients can benefit from new treatment options more quickly?
Thank you in advance for your help and your time.
Sincerely,
Ulrike Büchner
Dear Mrs. Büchner,
Thank you for your question regarding the development and approval of new medications. It is understandable that you are concerned and looking for an effective treatment for your chronic condition. I will be happy to provide you with a detailed explanation of how the process of developing and approving new medications typically works.
The development of a new medication is a very complex and time-consuming process that usually takes several years. The first step is the so-called preclinical phase, in which the medication is tested in the laboratory on cell cultures and animal models to assess its effectiveness and safety. This process can take several years before the medication can even be tested on humans.
Once the preclinical studies produce promising results, the clinical phase begins. This phase is divided into three stages: Phase I involves small groups of healthy volunteers to test the medication's tolerability. In Phase II, the medication is tested on a larger group of patients with the disease to determine its effectiveness and dosage. In Phase III, the medication is tested on an even larger group of patients to compare its effectiveness with existing treatment methods.
After completing the clinical studies, the pharmaceutical company must submit an application for approval to regulatory authorities such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA). The authorities then review the safety, effectiveness, and quality of the medication before approving it. This process can also take several years.
Overall, it can take up to 10 years or longer for a new medication to reach the market and become available to patients like you. However, there are ways to expedite this process, such as accelerated approval procedures for life-threatening conditions or orphan drug procedures for rare diseases. Collaboration between pharmaceutical companies, research institutions, and regulatory authorities can also help shorten the development process.
I hope that this information has been helpful to you. If you have any further questions or need assistance, I am at your disposal.
Best regards,
Jan Voigt
