Neuigkeiten & Ereignisse

Main Eurasian Economic Union (EEU) regulations of common biopharma & medtech market (Russia, Belarus, Kazakhstan, Armenia, and Kirgizstan) will officially come into effect since 06-May-2017. 

All registration dossiers of the drugs, registered in EEU members before 2016 or in accordance with the updated national regulations before 2021, should be aligned with EEU regulations’ requirements and provided in CTD format before 31-Dec-2025. Since 2019, all drug dossiers submitted within EEU regulations must include EEU GMP; national GMP/license will not be sufficient. 

ARS business development team took part in the key pharmaceutical event in Russia held in Moscow on 28-30-Mar-2017 (http://www.cphi.com/russia/). At the conference, a number of productive meetings with the new potential Clients have been conducted and the discussions of the new projects have been initiated. 

In January 2017, ARS team submitted an application to the Ministry of Industry and Trade for inspection of a German manufacturing site by the request of the international Client. This month, the body made a decision to inspect the facility in the coming summer. 

ARS extended a contract with the leading Russian pharmaceutical company through adding new well-studied generics for registration in Russia like Flutamid, Tamoxifen, Bleomycin, Carboplatin, and Chlorambucil.

ARS regular Customer has successfully passed the Russian GMP inspection of its manufacturing site in India. ARS team prepared and submitted an application to the Russian Ministry of Industry and Trade in February 2016. It took a year to receive a positive decision of the regulatory body in February 2017. 

ARS initiates a local crossover two-period comparative study of pharmacokinetics, bioequivalence, and safety of Pazopanib, film-coated tablets, 200 mg, in patients with renal cell carcinoma. The clinical trial will be sponsored by the leading Russian pharmaceutical company. 

ARS concluded a contract for filing substantial variations to normative documentation, dossiers, and instructions of four human immunoglobulins, human albumin, and blood coagulation factor VIII developed by the German biotech company. 

ARS signed an additional agreement with a Korean company for registration of its new biosimilar product in Russia. 

ARS made an agreement with a Belarus pharmaceutical company for its generics registration in Russia. These will be oncology and anti-viral drugs presented more than 20 years in the market. 

ARS signed an agreement for registration of a number of well-studied oncology generics of the leading Russian biopharmaceutical company. All the drugs are more than 20 years in the market. Among them, one can mention Doxorubicin, Cisplatin, Cyclophosphamide, Methotrexate, Etoposide, Fluorouracil as well as medicines treating renal failure like Ketoanalogues of aminoacids.