08.06.2015

ARS regulatory affairs team started essential documents preparation to apply for approval of local clinical trials of Lamivudine and its fixed-dose combination with Zidovudine. ARS logistics department provides the importation of the drugs for preclinical research purposes; according to the current law, some own non-clinical results are to be submitted to the Russian Ministry of Health to obtain a local clinical study approval as well as drug registration.

Regulatory package of the combination product of Paracetamol + Phenylephrine clinical trial application is in preparation now as well.