The Eurasian Economic Commission (EEC) has updated the procedure for the registration and examination of medicines.
The innovations primarily affect medicines that are equipped with additional devices for use, such as measuring devices and injection aids.
According to the updated requirements, manufacturers are obliged to include in the registration dossier documentation confirming the quality and functionality of all additional packaging components. At the same time, an important relaxation is the absence of the need for separate registration of such components as medical devices, which significantly simplifies the procedure for applicants.
Another significant innovation is the requirement to obtain a separate registration certificate for each new dosage form of a drug.
In addition, the rules for conducting trials of biological medicines in the EAEU were supplemented with two important chapters regulating work with high-tech medicines based on genetically modified somatic cells. Special attention is paid to innovative antitumor drugs that use modified T-lymphocyte killer cells to fight resistant forms of cancer.
The innovations primarily affect medicines that are equipped with additional devices for use, such as measuring devices and injection aids.
According to the updated requirements, manufacturers are obliged to include in the registration dossier documentation confirming the quality and functionality of all additional packaging components. At the same time, an important relaxation is the absence of the need for separate registration of such components as medical devices, which significantly simplifies the procedure for applicants.
Another significant innovation is the requirement to obtain a separate registration certificate for each new dosage form of a drug.
In addition, the rules for conducting trials of biological medicines in the EAEU were supplemented with two important chapters regulating work with high-tech medicines based on genetically modified somatic cells. Special attention is paid to innovative antitumor drugs that use modified T-lymphocyte killer cells to fight resistant forms of cancer.