Rules for medicines registration to clarify possibility of amending national marketing authorization applications until 2025

​ The draft amendments to the Rules for Marketing Authorization and Expert Assessment of Medicinal Products for Human Use were considered on October 26 at the third meeting of the Expert Committee for Medicinal Products chaired by Viktor Nazarenko, Member of the Board — Minister in charge of Technical Regulation of the Eurasian Economic Commission. The Working Group on common approaches to regulating the circulation of medicinal products within the Eurasian Economic Union prepared the amendments subject to practical application of the rules.
In particular, it is proposed to record a uniform approach developed by the Expert Committee for drawing up expert reports based on the results of generic drugs examination. The document entitles an applicant to revoke the Marketing Authorization Application and establishes a single deadline for applying for amendments to the Marketing Authorization Application of drugs registered according to national rules — until the end of 2025. Currently, the States can establish this deadline at their discretion within the transition period. However, marketing authorization holders who plan to introduce amendments should take into account that all marketing authorization applications shall be brought in line with the Union's requirements by December 31, 2025. 
The meeting also approved three draft recommendations of the Commission' Board: on an updated Directory of Concepts used within the Eurasian Economic Union in the field of medicinal products circulation​, on the Guidelines for the development and manufacturing of active pharmaceutical ingredients, and on the Guidelines for the study of toxicokinetics and the assessment of systemic effects in toxicological studies.
In particular, the Directory of Concepts used within the Eurasian Economic Union in the field of medicinal products circulation is planned to be updated with regard to the terms contemplated by the Commission's acts adopted in 2019-2020. 
Guidelines for the development and manufacturing of active pharmaceutical ingredients enable to provide uniform approaches to justifying the elaboration of their production process and the scope of development. This contributes to identifying potential critical quality attributes in active pharmaceutical ingredients, which help study and control the characteristics of the production process that affect the quality of a medicinal product. 
Guidelines for the development and manufacturing of active pharmaceutical ingredients imply selecting an appropriate production process for active pharmaceutical ingredients and determining a control strategy to ensure the efficiency of the process and the quality of these substances.
The latter of the approved recommendations regulates the study of toxicokinetics of active substances from the perspective of developing medicinal products for human use. This will enable to uniformly apply the methodology of toxicokinetic studies and elaborate recommendations for developing the research strategies in toxicokinetics. 

The document provides approaches to integrating pharmacokinetic studies into toxicology studies that enable us to study and assess the toxicological data and contribute to developing rational study designs.

The draft documents approved by the Expert Committee are scheduled for consideration at a meeting of the Commission's Board in Q4 this year.​