We live in an aging society. Medical standards continue to develop and medicine is constantly evolving as scientists carry out research into new drugs. More and more people require medication and cases of polymedication, where people need to take numerous different types of medicine every day, are becoming more common.

The long road from development to approval

Against this backdrop, how do we ensure the safety and quality of the drugs for the patient? How is drug safety regulated nowadays and which uniform standards need to be adhered to? In this blog post, you can find out more about drug safety, drug approval, and the different approval procedures.

The concept of drug safety

Drug safety, also known as pharmacovigilance, refers to the systematic and continuous monitoring of the safety of a drug. The drugs are tested in order to identify and assess undesirable or even harmful effects for humans or animals. In order to protect patients, drugs must obtain official approval before they can be placed on the market. 

The German Medicinal Products Act (AMG) came into force in 1961, establishing a standardized legal regime for the provision and safety of drugs. Due to the continuous evolution of the legislation, the act has grown over the years from 65 paragraphs to almost 200. Guidelines and measures are constantly being optimized. 

In the future, drug safety will continue to be regarded as an indivisible concept comprising product safety, the safety of the distribution channels, and safe and effective drug use.