After drugs that have been developed and begun to be manufactured have received approval and registration and have been introduced to patients, it is necessary to monitor the undesired effects of these drugs in addition to their therapeutic effects.
Collection of clinical data pertaining to the safety of drugs in daily clinical practice, monitoring of problems faced during the drug's implementation, determining the cause of these problems, their diagnosis, investigation, recording, notification and taking necessary precautions fall within the scope of Pharmacovigilance practices.
The Pharmacovigilance Committee was established as the Regulation Regarding the Monitoring and Evaluation of the Safety of Medicinal Products for Human Use (Pharmacovigilance Regulation) went into effect in 2005 in order to investigate and evaluate the problems of research-based pharmaceutical companies and the Turkish pharmaceutical industry regarding Pharmacovigilance issues as well as present solution proposals to pertinent authorities and enable access to required solutions. Its goal is to foster information-sharing among companies regarding pharmacovigilance practices as well as ensure contact and collaboration with pertinent associations and institutions in addition to the Turkish Pharmacovigilance Center (TÜFAM) under the aegis of the Ministry of Health. |