Modern medicine and the pharmaceutical industry have played a key role in doubling life expectancy at birth over the past hundred years. Medications based on scientific evidence can help heal, relieve symptoms, and prevent disease. Almost everyone takes medication in their lifetime, even several at once, which in most cases does not cause any problems, but it can be said that there is no effect without side effects. All drug therapies may have some risks, but the consequences of untreated disease should also be considered. Investigating and reporting drug-related side effects began to become important in the late 19th century, and over the years, drug safety criteria became increasingly stringent. It takes decades from discovering the molecule, through pre-clinical and clinical trials, to patent expiration and generic manufacturing. The number of subjects enrolled in clinical trials is much smaller than the target population; for this reason, it may later reveal that the effect is not as significant as expected or that side effects go unnoticed during drug development. For this reason, monitoring the safety and efficacy of medicines is an essential task to ensure that the products are used as accurately as possible in both the target population and the indication.

Pharmacovigilance is the set of activities carried out to ensure the safe use of medicines. It monitors the benefit/risk balance of drugs throughout their life cycle. Our goal is to identify and evaluate changes in the benefit/risk balance, minimize the risks, and maximize the benefits of the medication. Medicine should only be authorized and used if the benefits outweigh the risks. Therefore, we need to collect comments from both healthcare professionals and those who use the drug, allowing for the safe use of the drug. Our other goal is to extract mapping the safety profile of medicines manufactured by ExtractumPharma Co. Ltd. and the collection, analysis, and transmission of adverse events to the European Medicines Agency.

Consequently, pharmacovigilance serves the preservation and protection of the health of both the individual and the communities in a broader sense. Therefore, it is essential to gather and evaluate the experience of healthcare professionals and patients, which can achieve with the help of the pharmacovigilance system operated by our company, the maintenance of which involves several tasks:

• We perform our work following international and domestic legislation and the requirements of Good Pharmacovigilance Practice.
• We collect and analyze data and keep pharmacovigilance data up to date.
• We receive and process adverse reaction reports.
• We observe the scientific literature on the products / active substances.
• We change the product information (Summary of Product Characteristics and Package Leaflet) if it's necessary to inform the users.
• We maintain an ongoing dialogue between healthcare professionals, patients, and the authorities.
• We prepare official documentation.

Our company makes every effort to protect the privacy of the notifier and the patient, and you can read our privacy statement on the website.

Please note that if ExtractumPharma Co. Ltd. If you notice any undesirable event in connection with the product manufactured by us, please feel free to contact us!