What really is involved in developing a new drug?

October 9, 2012


Did you know that it takes on average 12 years for a new medicine to get from the lab to the shelves of your Pharmacy? Did you know that only 5 in every 5.000 compounds that enter the preclinical testing phase actually make it to human testing? Did you know that only one of these five drugs tested in people is approved by the authorities? Did you know that it is estimated that a company may spend € 250,- to € 800,- million to get one drug approved?

Let’s take a look at the steps involved in developing a new drug. Preclinical Testing: This is the first testing done in the laboratory. A pharmaceutical company will conduct studies in the lab and on animals to show the biological activity of the compound against a targeted disease and evaluates it for safety. These tests take about 3 1/2 to 4 years to complete.

Clinical Trials, Phase I, II, & III
After the preclinical testing the next phase of testing begins: the clinical trials.

Phase I: This phase of the testing takes about a year and involves about 20 to 80 normal, healthy volunteers. The tests study a drug’s safety profile, including the safe dosage range. The studies also determine how a drug is absorbed, distributed, metabolized and excreted, and the duration of its action.

Phase II: In this phase, controlled studies of approximately 100 to 300 volunteer patients (people with the disease) assess the drug’s effectiveness. This phase normally takes about 2 years.

Phase III: This phase involves 1,000 to 3,000 patients in clinics and hospitals. Physicians monitor patients closely to determine the efficacy and identify adverse reactions. This phase lasts about three years.

New Drug Application (NDA): After all of the clinical trials mentioned above are completed, then the company analyzes the data and files an NDA with the EMA if the data successfully demonstrates safety and effectiveness. The EMA is usually about 100,000 pages or more and contains all of the scientific information that the company has gathered. Once the EMA approves the NDA, the new medicine becomes available for the Cyprus Pharmaceutical Services decide if they want to make the drug available for the local physicians to prescribe it and if they want to make the medicines available for the government hospital doctors. Once it becomes available for physicians to prescribe, the company must continue to submit periodic reports to the EMA, including any cases of adverse reactions and appropriate quality control records. The EMA requires some medicines to have additional studies to evaluate the long-term effects of the drugs.

Do you now understand why the Pharmaceutical Industry is working with doctors and doctors associations to have everybody understand what the benefits of the new medicines are? Do you now understand why the Pharmaceutical Industry is trying to get the medicines to only those people who need the medicine and can benefit from the new medicine? Do you now understand why we are doing all we can to prevent counterfeit medicines flushing the markets? Do you now understand why we support strict regulations on prescribing medicines? Do you now understand why I’m extremely proud to be working for this life saving, innovative industry?

*Daan Gijbels is the Vice President of the Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA).