Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004); - Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient (HS 300630)
The draft guidelines for the assessment of the quality and research of drugs based on liposomes, micelles and drug-containing coating of nanoparticles. (82 page(s), in Russian)
The draft guidelines for quality assessment and research of liposome-based drugs, micelles and drugs containing nanoparticle coatings apply to the development of copied drugs from the liposome, micelle and drug group, containing nanoparticle coatings for subsequent registration on the territory of the Eurasian economic Union and provides for the need to establish uniform requirements for the evidence-based study of the equal effectiveness and interchangeability of copied and reference drugs based on liposomes, micelles and drugs containing nanoparticle coatings used in the treatment and prevention of human diseases, in order to:
identification of ineffective and (or) non-equivalent drugs at the pre-registration stage, resulting in the risk of harm to human life and health;
elimination of the need to duplicate studies of these groups of drugs in each of the member States of the Union.
The draft guide has been prepared in order to:
- protection of life and health of the patient (as the final consumer of medicines);
- protection of the interests of the health care system as a whole (as the primary consumer of medicines) by ensuring the use of proven equally effective and interchangeable copied medicines;
- protection of the interests of patients participating in the study by clearly regulating the procedure for conducting bioequivalence studies of these groups of drugs.