Clinical Trial Inspections

2025

No.	Applicant	Clinical trial (No. and title)	Phase	Medicinal product status	Type of authorisation procedure	Inspection type	Inspection result/status	Clinical trial authorisation in Russia	Pharmaceutical inspection results
1.	Microgen	ААМ-Р-III-00-003/2021 ‘A randomised comparative clinical trial to evaluate the tolerability, reactogenicity, safety, and immunogenicity of DTaP-M vaccine in volunteers aged 18–60 years’	II-III	Originator	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	Completed	Clinical trial authorisation (in Russian)	Microgen Inspection Results (in Russian)
2.	Ipsen	GFT505B-319-1 ‘A double-blind, randomised, placebo-controlled study and open-label long-term extension to evaluate the efficacy and safety of elafibranor 80 mg in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid’	III	Originator	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	Completed	Not applicable	Ipsen Inspection Results (in Russian)
3.	Hetero Labs Limited (India) Moscow Office	SIL_HL_26 ‘A randomised, single-centre, open-label, two-sequence, two-stage, crossover comparative study to evaluate the comparative fed bioavailability and bioequivalence of Silodosin 8 mg capsules (Hetero Labs Limited, India) and Urorec 8 mg capsules (Recordati Ireland Ltd., Ireland) in healthy male volunteers’	BE	Generic	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	Completed	Clinical trial authorisation (in Russian)	Hetero Labs Limited (India) Inspection Results (in Russian)
4.	Promomed, Russia	MOL-042024 ‘A multicentre, randomised, double-blind, placebo-controlled comparative study to evaluate the efficacy and safety of JCBC00101 (Promomed, Russia) in patients with influenza and/or ARVI’	III	Originator	Bringing marketing authorisation into compliance with the EAEU requirements, mutual recognition procedure	For cause, during medicinal product authorisation procedures	In progress	Clinical trial authorisation (in Russian)
5.	Dr. Reddy’s Laboratories Ltd. (India) Russian Office	DRL_RUS/MDR/KCT/2024/ BEMPEZ_FAST ‘An open-label, randomised, fully replicate, crossover, single-dose, comparative study to evaluate the relative fasting bioavailability and bioequivalence of Bempedoic acid + ezetimibe manufactured by Dr. Reddy’s Laboratories Ltd. (India) and NEXLIZET® manufactured by Esperion Therapeutics, Inc. (USA), 180 mg +10 mg film-coated tablets in healthy volunteers’	BE	Generic	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	Completed	Clinical trial authorisation (in Russian)	Dr. Reddy’s Laboratories Ltd. (India) Russian Office Inspection Results (in Russian)
6.	Medintorg	Healive-2022 ‘A multicentre, randomised, double-blind comparative study to evaluate the safety and immunogenicity of Healive® vaccine for active prevention of viral Hepatitis A’	III	Biosimilar	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	In progress	Clinical trial authorisation (in Russian)

2026

No.	Applicant	Clinical trial (No. and title)	Phase	Medicinal product status	Type of authorisation procedure	Inspection type	Inspection result/status	Clinical trial authorisation in Russia	Pharmaceutical inspection results
1.	PSK Pharma	HCR/III/DENOSOL/12/2019 ‘A multicentre, international, randomised, parallel-group study to evaluate the pharmacokinetics, pharmacodynamics, efficacy, and safety of Denosumab (Hetero) compared with Xgeva® 120 mg (70 mg/mL) 1,7 mL solution for subcutaneous injection (Amgen) by multiple subcutaneous injections in patients with bone metastasis from solid tumours’	III	Biosimilar	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	In progress	Clinical trial authorisation (in Russian)
2.	Eisai	A long-term multicentre, randomised, double-blind, controlled, parallel-group study of the safety and efficacy of Lemborexant in subjects with insomnia disorder	III	Originator	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	In progress	Not applicable
3.	GENERIUM	GNR127-BET01 ‘A two-stage clinical trial with dose escalation at the first stage and a single-blind, placebo-controlled clinical trial for evaluation of efficacy, safety, reactogenicity, and immunogenicity of GNR-127 at the second stage in patients with allergic rhinitis sensitised to birch pollen’	I-II	Originator	Conditional authorisation, mutual recognition procedure	For cause, during medicinal product authorisation procedures	Completed	Clinical trial authorisation (in Russian)	Generium Inspection Result (in Russian)
4.	Nanolek	201719906 ‘А phase III, randomised, blind, parallel-controlled trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine’	III	Originator	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	In progress	Not applicable
5.	PHARM AID LTD	ВВО 001/24 ‘A multicentre, prospective, randomised, double-blind, comparative study to evaluate the efficacy and safety of live attenuated varicella vaccine in healthy children with a preliminary open-label, prospective, one-cohort study to evaluate the efficacy and safety in healthy adult volunteers’	III	Originator	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	In progress	Clinical trial authorisation (in Russian)
6.	SPbSRIVS FMBA of Russia	02-PCV-16-06/24 ‘A phase III, multicentre, randomised, double-blind, controlled study to evaluate the immunogenicity, safety, and tolerability of PCV-16 pneumococcal vaccine compared with Prevenar® 13 vaccine in volunteers aged 18 years and older’	III	Originator	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	In progress	Clinical trial authorisation (in Russian)
7.	Petrovax	2015L05606 ‘А randomised, blind, and similar vaccine-controlled phase III clinical trial to evaluate the safety and immunogenicity of group ACYW135 meningococcal conjugate vaccine (CRM 197)’	III	Originator	Mutual recognition procedure	For cause, during medicinal product authorisation procedures	In progress	Not applicable