Pharmacovigilance: rules, services, good practice
Pharmacovigilance is the process of monitoring the safety of medicine after they have been approved for use by the public. This includes the detection, assessment, understanding, and prevention of adverse effects or any other problems. The goal of pharmacovigilance is to ensure that the benefits of a drug outweigh its risks, and to protect public health by identifying and minimizing the risk of adverse reactions to medicine.
Who controls the pharmacovigilance process
Pharmacovigilance is typically controlled by government regulatory agencies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. These agencies are responsible for evaluating the safety and efficacy of medicine and ensuring that they meet certain standards before they are approved for use by the public. In addition, pharmaceutical companies and healthcare providers also have a responsibility to monitor and report any adverse reactions or problems associated with their products and to collaborate with regulatory agencies.
Pharmacovigilance in the CIS countries and Ukraine
In Ukraine, the main agency responsible for pharmacovigilance is the State Service of Ukraine on Medicines and Drug Control. In Kazakhstan, the main agency responsible for pharmacovigilance is the “National Center for Expertise of Medicines and Medical Devices” of Committee of Control of Medical Products and Medical Devices under the Ministry of Health of the Republic of Kazakhstan. In Georgia, the main agency responsible for pharmacovigilance is the Agency for the State Regulation of Medical Activities. In the Republic of Belarus, the main agency responsible for pharmacovigilance is the UE “Center for Expertise and Testing in Healthcare” the Ministry of Health of the Republic of Belarus.
These regulatory agencies are responsible for the collection, analysis and dissemination of information about adverse reactions to medicine, the monitoring of their safety and efficacy in use, and taking necessary measures to ensure their safe use. In addition, pharmaceutical companies and healthcare providers also have a responsibility to monitor and report any adverse reactions or problems associated with their products and to collaborate with the State Inspectorate for Medical Products.
Why you can be sure of the quality of the medications you use
Patients can be reassured about the quality of medicine for several reasons. Firstly, medicine must meet strict standards set by regulatory agencies such as the FDA in the United States and the EMA in Europe before they are approved for use by the public. These agencies thoroughly evaluate the safety, efficacy and quality of medicine to ensure that they are safe and effective for their intended use. Secondly, once a medicine is approved and on the market, pharmacovigilance systems are in place to continuously monitor the safety of the medicine. This includes the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems. Any potential issues are identified and addressed quickly to minimize the risk of harm to patients. Thirdly, manufacturing of medicine must meet good manufacturing practices (GMP) which are guidelines that set standards for the design, monitoring and control of manufacturing processes and facilities. This ensures that the medicine are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization.
All these measures together help to ensure that the medicine available to patients are of high quality and safe for use.
It is important to note that patients should always follow the guidance of their healthcare provider, read the label, and report any adverse reactions or side effects they experience while taking a medication.
We at Delta Medical cooperate very closely with all regulatory agencies, strictly comply with all the norms of the current legislation of the countries in which we are present. Each of our employees is instructed in detail and from time to time confirms their knowledge during special tests.