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Registration of Medical Drugs in Russia Registration of Pharmaceuticals in Russia
Registration of Medical Drugs in Russia Registration of Pharmaceuticals in Russia
Our news
- 18/07/2019: Pharegis implemented optimized procedures for state registration of pharmaceuticals in Eurasian Economic Union.
- 20/06/2019: Pharegis updated timelines and practical approaches for Russian and EEU GMP inspection applications and procedures.
- 03/04/2019: Renewed general monographs of Russian state pharmacopeia XIV ed. have been analyzed.
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Regulatory news
Drugs.com - New Drug Approvals
- FDA Approves Exxua (gepirone) for the Treatment of Major Depressive Disorder in Adults
- FDA Approves Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for the Treatment of Late-Onset Pompe Disease
- U.S. FDA Approves Subcutaneous Administration of Takeda's Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
- FDA Approves Bosutinib for Pediatric Patients with Chronic Myelogenous Leukemia
- FDA Approves Ryzumvi (phentolamine) Ophthalmic Solution for the Treatment of Pharmacologically-Induced Mydriasis
News and press releases
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023, PRAC, 29/09/2023
- EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023
- Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023
Drugs.com - Clinical Trials
- SciSparc Initiated Its Clinical Trial with SCI-210 in Pediatrics with Autism Spectrum Disorder TEL AVIV, Israel, Sept. 29,...
- BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS NEW YORK, Sept. 27, 2023....
- IDEAYA Biosciences Receives Fast Track Designation for IDE161 in a Second Indication for the Treatment of Pretreated, Advanced or Metastatic HR+, Her2-, BRCA1/2 mutant Breast Cancer SOUTH SAN FRANCISCO, Calif.,...
- NMD Pharma initiates Phase II trial of NMD670 in Spinal Muscular Atrophy Aarhus, Denmark, 26...