HOW can patients be assured of safety?
All European pharmaceutical companies are legally required to monitor the use and effects of all their medicines. They must have systems in place to detect, assess, understand and endeavour to communicate any adverse reactions or any other medicine-related problem. The science and activities of these processes are known as Pharmacovigilance. As part of the pharmacovigilance process each manufacturer must provide a description of their pharmacovigilance system before its medicine is approved. This system is inspected by the regulatory authorities. In addition, for every new medicine, including biosimilar medicines, a Risk Management Plan (RMP) must be submitted and agreed to by the EMEA. The RMP describes what is known about the safety of the medicine and outlines how the manufacturer will further monitor and fill any gaps in knowledge as well as any measures needed to minimise any risk from the medicine. This plan must be regularly updated throughout the entire time the medicine is mar
All European pharmaceutical companies are legally required to monitor the use and effects of all their medicines. They must have systems in place to detect, assess, understand and endeavour to communicate any adverse reactions or any other medicine-related problem. The science and activities of these processes are known as “Pharmacovigilance”. As part of the pharmacovigilance process each manufacturer must provide a description of their pharmacovigilance system before its medicine is approved. This system is inspected by the regulatory authorities. As part of the pharmacovigilance process each manufacturer must provide a description of their pharmacovigilance system before its medicine is approved. This system is inspected by the regulatory authorities. In addition, for every new medicine, including biosimilar medicines, a Risk Management Plan (RMP) must be submitted and agreed to by the EMEA. The RMP describes what is known about the safety of the medicine and outlines how the manufac
