The process of making and marketing new medications to treat all manner of conditions is a lengthy and heavily scrutinised process. So what actually goes in to making sure that blister pack of tablets helps you get rid of your latest ailment?

Here is an outline of the pharmaceutical creation process from inception through to prescription.

Step 1: Assessing Medical Need

Obviously pharmaceutical companies aren’t randomly mixing up potions to see what they’ll do. Instead each and every single medication project will start with a medical need that the company has identified needs addressing, and they’ll then get to work on how best to address that need, be it a faster acting anti-inflammatory or a drug to tackle the debilitating effects of HIV.

Determining the intended target of the proposed medication is the very first step and requires extensive study of that target, whether it’s a particular disease or infection, or a part of the body that requires altering (such as reducing swelling). This stage is known as the preclinical trials stage. It would typically take 2 to 3 years.

Step 2: Ensuring Safety First

As you might imagine there are stringent laws around ensuring a drug’s safety for use in humans and before trials can begin on test subjects who’ve volunteered, the regulatory body for that country (the FDA in the US or the MHRA in the UK) would need to approve the test drug after reviewing its compound structure. If there’s any doubt over its safety then approval will not be given and the pharmaceutical company will have to go back to the drawing board.

Step 3: Clinical Trials

Once a drug has been reviewed by the regulatory body and deemed to be safe enough for human trials, the pharmaceutical company can begin testing on test subjects - guinea pigs who have volunteered to have the drug’s effects tested on them. Volunteers for clinical trials are usually incentivised with money and can earn several thousand dollars for an extended study.

During these trials many of the compounds making up the proposed new drug will be rejected and on average less than 10% of the compounds tested will ever make it past this stage. This clinical trial phase can last anywhere up to 10 years, involving thousands of test subject patients.

Step 4: Getting Approval

The same regulatory bodies who determined whether or not the drug would advance to the clinical trials stage must now review whether or not the trials have been conclusive enough to deem it safe and effective enough to be rolled out across the country. Getting approval from the regulatory body in your country can be a very long and protracted process, taking up to eight years in some instances.

The regulatory body has to be as certain as it can be that the drug has no unwanted long term effects which is why the process is so lengthy. There are notable high profile cases from history of drugs being released to the public without their effects being fully known and having devastating consequences as a result. One of the most famous examples is the drug Thalidomide which was prescribed to pregnant women in the 1950s and caused serious birth defects to many of their children. This case, along with others, saw regulations in the pharmaceuticals industry tighten considerably as a result.

Step 5: Getting to Market

By this point you could be as far as 20 years from your drug’s original conception but once approval is given the route to market is far quicker. In the period whilst waiting for approval to be given the pharmaceutical company will have refined their manufacturing processes to make the drug more economical to produce and assuming nobody else has come along with a better alternative in the intervening period, it will be time to release your drug to the world.

Specialist pharma logistics companies exist to manage the complex distribution process that is involved with getting new medications to registered pharmacies up and down the nation, or even across the continent, and the vehicles transporting these drugs need to be precisely temperature controlled and exceptionally secure.