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A new complex of indium(III)chloride with etioporphyrin-I was synthesized and characterized. As with naturally occurring extraligated etioporphyrins, the InCl-EtioPÀ I spectrum in solution has a very strong B-band and a more than an order of magnitude weaker Q-band, but this difference diminishes in solid films of InCl-EtioPÀ I obtained by thermal evaporation in vacuum. In a solid, molecules have a tight convex-convex arrangement in a 2D double layered structure with interplane distance of 3.066 Å. The conductivity of films can easily be activated by the action of temperature or light. In the cells with symmetrical lateral contacts the photocurrent exceeds the dark current by about three orders of magnitude, with the contribution of photons in the Q-band range being greater than expected from the experimental or calculated absorption spectrum. The Q-bands contribute significantly to the photovoltaic effect in the ITO/InCl-EtioPÀ I/Al sandwich cells. Such cells show an untypically strong signal in the photodiode regime, which yields the spectral detectivity of 10^12 Jones.

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Since 2021, the marketing authorisation (MA) of new medicinal products in the Russian Federation has been carried out according to the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use that are implemented by Decision No. 78 of the Council of the Eurasian Economic Commission dated 3 November 2016. The Member States of the Eurasian Economic Union (EAEU) must fully transition to the new regulatory framework by 31 December 2025. Therefore, MA holders are required to bring their existing product dossiers into compliance with EAEU requirements and continue submitting new product applications and dossier variations. Under the circumstances, the burden on regulatory authorities has increased significantly, regulatory mechanisms have become more complicated, and applicants have faced the challenge of swift adaptation to the latest requirements. To contribute towards the success of regulatory submissions, this article covers the sequence of regulatory procedures, the scope of work, and recommendations on dividing the procedures into stages, optimising each stage, determining goals and priorities, and assessing timelines and possible risks. To make the approval process more efficient, the authors illustrate the application of different procedures throughout a typical lifecycle of a dossier.

The legislation of the Eurasian Economic Union (EAEU) includes all the necessary requirements and tools to implement a unified approach to preparing Module 1 of the electronic Common Technical Document (eCTD) for the concerned member states (CMSs). However, the approaches to the matter and the recommendations provided to applicants differ across member states. This causes significant ambiguity and imposes an excessive burden on the applicants. Drafting of a guideline on preparation of eCTD Module 1 for the CMSs will allow for tackling this important grey area in the EAEU regulatory framework, as regulatory authorities are lacking consensus on country-specific submissions. Currently, pharmaceutical industry stakeholders consider the Russian experience of implementing the legislation in question the most successful, so it is proposed to convey this experience to the common market of the EAEU.