Safety in drug approval
The Austrian drug approval agency AGES PharmMed states that both patients and physicians can assume that the benefit of a drug used in its field of application is in an acceptable ratio to the risk. The task of AGES PharmMed as the national drug agency is to evaluate this risk-benefit profile of the drugs available in this country and to approve a drug only if this ratio is appropriate and the benefit exceeds the risks. Currently, about 15,400 drugs are available in Austria; in 2008 alone, 613 drugs were approved by AGES PharmMed.
The development of a drug is a lengthy process. Only a vanishingly small fraction of drug ideas are approved, even after many years and rigorous testing: After all, out of thousands of molecules, on average only one makes it to human clinical trials. And here, too, there is only a slim chance of approval: only one in ten investigational drugs makes it to the finish line. Approval is based on scientifically recognized and strictly regulated standards to determine whether the benefits are in acceptable proportion to the side effects. All drugs have side effects and our knowledge of them is dynamic, growing as long as a product is on the market. When a drug comes up for approval, safety data have usually been collected with hundreds or a few thousand patients. Of course, that is too little to detect very rare side effects. That's why ongoing market surveillance, known as pharmacovigilance, is so important. In this process, all safety signals are used to optimize the benefit-risk profile of a drug: Indications for use are restricted, warnings are issued and, in rare cases, drugs are withdrawn from the market. In 2008, BASG / AGES PharmMed received 2,885 reports of adverse reactions to human medicinal products.
