Neuigkeiten & Ereignisse

The trends and opportunities in the multinational multicenter clinical trials (MMCT) in Russia are reviewed in the recent article.

ARS analyses the potential of overseas generic drugs from ICH region and ‘pharmerging’ countries in the Russian pharmaceutical market.  Please see the article here  EN  DE FR

The ARS CRO has been contracted by the Russian pharmaceutical company to register its medicines in the Russian MoH , namely: Paracetamol 750 mg + Phenylephrine 10 mg + Pheniramine 20 mg + Caffeine 30 mg FDC in powder; Nimesulide, 100 mg, granules for suspension and tablets; Pancreatin 10 000 and 25 000 units, Diosmin 450 mg + Hesperidin 50 mg, film-coated tablets).

The ARS clinical CRO concluded a contract for a local registration Phase III open-label randomized comparative superiority clinical study of the efficacy and safety of a drug developed by an Indian pharmaceutical company in adult patients with acute bronchitis. 82 patients will be randomized into the clinical trial. Five Russian investigative centers will participate in the project. ARS will provide full-service support of the study as well as further marketing authorization of the medicine in Russia. 

ARS made an agreement with the Russian pharmaceutical company to design a Phase III study in children. The study results will be used in filing a substantial variation in the drug registration dossier comprising changes to the drug’s application instruction.  

ARS won a contract for Naftifine hydrochloride solution marketing authorization in Russia. No own preclinical and clinical research data will be required. Literature review will be enough for the drug registration in the Russian Ministry of Health. 

The ARS Business Development Director Ekaterina Mochalova participated in the leading pharmaceutical event in the field of pharmaceutical ingredients, finished drugs, engineering, equipment, and outsourcing in Russia and CIS IPhEB

Around two tens face-to-face meetings with the representatives of the biopharmaceutical industry from the Baltic States, Belarus, China, Germany, India, Kazakhstan, Russia, South Korea, and Syria were conducted on 11-13-Apr-2018. Potential collaboration within clinical research projects, bioequivalence studies, and medicines marketing authorization in Russia were negotiated.

The ARS PharmRussia CRO won a tender for a Phase III double blind placebo-controlled parallel clinical study of efficacy and safety in patients with sleep disorder. 184 subjects will be enrolled at five investigative sites in Moscow, St. Petersburg, Yaroslavl, and Tver, Russia. ARS will be responsible for medical writing, project management, regulatory approval of the clinical trial at the Russian MoH and LECs, clinical monitoring, data management and statistics, final clinical study report preparation and submission to the regulatory authorities. The clinical research project will be performed in compliance with the Eurasian Union (EAEU) requirements. The final aim of the study will be marketing authorization of the product as an OTC drug.

ARS PharmRussia gets a new Client that is one of the top biopharmaceutical companies worldwide. ARS team won a tender to conduct a bioequivalence study of an oncology generic drug in Russia. This will be the first project with this Partner.

ARS reveals the current challenges and opportunities of a foreign drug registration in Russia. The article posted should be very helpful for the overseas drug developers and manufacturers.