To ensure that every Roche product is both effective and safe, we have established a systematic process designed to optimise patient safety throughout the lifecycle of a medicine.
We collaborate with regulatory agencies, monitor reports of adverse events experienced by patients and communicate on our product safety activities, as appropriate to the audience. Any medicine may cause side effects in some patients. Our priority is to make sure that the therapeutic benefits of the medicine outweigh the risks. read more on safety and transparency in our clinical studies
Maintaining high standards
Our products have well-characterised benefit-risk profiles based on available safety and efficacy information. These are derived from the clinical trials on which their approval by health authorities was based, extensive programmes of post-approval clinical studies, scientific publications, pre-clinical data and epidemiologic publications. This information is complemented throughout the life of the product with spontaneous safety reports primarily received from doctors and patients.
Conducting rigorous clinical trials
All medicines are subject to rigorous testing before they are approved by regulatory authorities, such as the US Food and Drug Administration, the EMA for EU and local agencies from other countries. Before a medicine is given to patients, our findings from pre-clinical studies (before entry into humans) are carefully analysed by Roche scientists and discussed with regulatory authorities. The medicine then undergoes a long process of investigation using well-designed and controlled clinical trials. read more on our dedicated Roche trials website
Continuously monitoring patient safety
We want to know about every adverse drug event occurring in patients taking a Roche medicine. That’s why we continuously collect, analyse and monitor information about any adverse events associated with our products.
Some information on side effects and related risks may be known only after a drug is used in large numbers of patients in the wider population. For that reason, our safety risk management process begins in the early stages of the medicine’s development and continues for the entire time the medicine is on the market. This helps us to identify potential side effects before they occur, enabling appropriate preventative strategies to be designed and implemented.
Effective communication and teamwork is central for monitoring the safety of our products and for ensuring the safe use of our products. In addition to communicating openly with regulators and other stakeholders, we require all employees to immediately report any drug safety or quality issue to the respective safety personnel. read more about safety and transparency in our clinical trials