RUS/118
WTO/TBT
RU Russie
  • 11 - Technologies de la santé
2021-06-30
2021-05-03

Medicinal products

Draft amendments to the Rules for investigation of biological medicinal products of the Eurasian Economic Union (156 page(s), in Russian)

The draft amendments to the Rules for investigation of biological medicinal products of the Eurasian Economic Union provide for the elimination of differences in the requirements for pharmaceutical development, planning and conducting studies of the safety and quality of blood products, by establishing unified, objective and transparent rules for research of this group of drugs and also avoid the possibility of unreliable reporting on the safety of blood products from infectious agents that may be dangerous to life, health and well-being of patients.