Though the process of creating a medicine and placing it on the shelves of a pharmacy or drugstore may appear simple, there are many distinct procedures involved, and it can be challenging! The various methods your medication goes through before it is delivered to you are described below, so continue reading in order to find out!
Take a Look at Your Lab Work
Ideally, you’ve already made an educated guess as to what you want the medication to do. For instance, if you want to create a tablet that lowers blood pressure, you will test in the lab using computerized models whether it decreases blood pressure.
The treatment you’re developing will directly lead to a higher rate of survival or a reduction in disease symptoms.
When your laboratory study is over, you will also analyze the data to make sure it is safe for people to consume.
Always keep in mind that side effects are a possibility with all drugs. However, the likelihood of side effects should be low and outweigh any actual negative effects compared to the benefits that the medication will provide. Some organizations are responsible for the development and production of contracts that accelerate how pharmaceutical companies bring drugs and therapies to market. One of those is CDMO, and on this website, you can learn more about it. If the medication fails at this point, it won’t undergo additional testing and won’t be placed on the market. If it works, you move on to the trials!
Trials to Complete
- Phase 1: To determine whether the treatment can be taken for an extended period of time, you will test it on a group of healthy human volunteers.
- Phase 2: A group of volunteers who have the condition you’re aiming to treat will now be used to test the medicine (or reduce symptoms). They will make sure that it has the expected impact and benefits the sampled small population.
- Phase 3: You will now test the medication on a sizable patient population to see if it is making a difference in their health or disease symptoms.
Regulators Need to Approve
You must either go back and fix what went wrong with your medicine if it fails any of the phases, or you must stop the trial altogether. If your medication has successfully completed the trials, the body in charge of overseeing the sale of medications will review it, and if it is found to be effective, it will be put on your shelves!
Drug development and marketing authorization procedures are the same everywhere in the world. In most nations, a submission for marketing authorization is filed to the national regulatory body for medications that make it through phase 3. The MHRA in the UK and the Food and Drug Administration (FDA) in the US are responsible for this.
To avoid having to submit multiple applications to different nations, drug companies in Europe typically choose to submit a single application to the European Medicines Agency (EMA) to get marketing permission for the entire continent.
The submission includes preclinical and clinical data gathered during testing, such as details on the substance’s composition and production method, pharmacology and toxicity, human pharmacokinetics, and the outcomes of the clinical trials.
Phase 4 trials may be required by regulatory bodies for post-marketing safety surveillance (pharmacovigilance) or they may be conducted by the company to allow them to focus on certain markets.
Any chemical that has promise early in the development process will be patentable by pharmaceutical corporations. A drug’s production, composition, and, in some situations, use are all covered by a patent, which for 20 years precludes other businesses from imitating it.
The goal of a patent is to give the pharmaceutical business that created it the ability to recover its development costs, generate a profit, pay for the development costs of medicines that failed throughout testing, and invest in the creation of new, cutting-edge medicines in the future. Half of the patent period will often have passed by the time medicine has undertaken the necessary testing and been granted a license.
When a drug’s patent expires, generic versions of the drug can be produced and sold. If doing so does not extend the time the drug is under patent protection past 15 years from the day it gained regulatory clearance, the patent protection period for some drugs may be extended for up to an additional five and a half years.
We hope that it is now clearer to you what the medicine has to go through to reach the shelves and its consumers.