Pharmaceutical laboratories that launch a product in the EU have the legal obligation to submit a risk management plan (RMP), which includes a program or activities to monitor the therapeutic response to the drug once it is on the market. Thus, they must have mechanisms to collect, detect, evaluate, understand and communicate possible adverse reactions attributable to the drug and any other problem related to a drug (decreased efficacy, for example).
El PGR submitted by the company must be accepted by the European Medicines Agency (EMA) and forms an integral part of the marketing authorization. It describes everything that is known about the drug's safety and details how the manufacturer will continue to monitor it. That PGR is summarized in the European public assessment report (EPAR) after authorization of the drug and must be updated throughout the life of the product.
Once the drugs begin to be marketed, the pharmaceutical companies must prepare Periodic reports to review all available safety data, known as (IPS) and whose purpose is to detect any change in the benefit/risk balance of any drug. Sometimes the laboratory undertakes to perform additional post-clearance safety studies (EPAS).
To carry out this monitoring, the precise identification of the biomedicine and the manufacturing batch is therefore of particular importance. For this reason, EU legislation establishes that each adverse reaction report sent to you must state the name of the medicine and the batch number.
Furthermore, the EU legislation about pharmacovigilance It has also provided that for all biomedicines, original and biosimilar, the data sheet and package insert must include a black symbol and a legend that invites reporting of adverse reactions.
In addition to all this, the European Medicines Agency is responsible for the development and maintenance of eudravigilance, a data processing network and management system for reporting and evaluating suspected adverse reactions during the development stage and after marketing authorization of medicines in Europe.
Conclusion: all biopharmaceuticals, including drugs biosimilars, follow the same pharmacovigilance rules and are subjected to rigorous regulatory and scientific evaluation by the same expert scientific committees at the EMA.
