Solagran's liver treatment 'fast tracked' in Russia

Melbourne-base Solagran has been granted Russian approval to register Ropren, the finished form of Bioeffective R, as a new medicine for the treatment for chronic liver disease.

"This acceptance means that Solagran has succeeded in fast tracking the approval process and in bypassing the need for phase III clinical trials," said Solagran director of research Prof Roschin, in a letter to Solagran directors released yesterday. "This has shortened the timeframe for registering Ropren by at least one year, and saved the company millions of dollars."

The documentation is now in the hands of the Presidium of the Pharmacological Committee which meets three to four times per year and according to Roschin the approval is considered a formality unless there are comments to consider from the previous reviewing committees.

"In the case of Ropren there are no such comments. So unofficially, medical approval is 99 per cent complete. But we have to allow 1 per cent for force majeure," he said.

Roschin indicated that he and his team believe that the Prescribing Instruction will be approved in late March or early April, and that the Manufacturer's Pharmacopoeial Article, which is due to be submitted to the Pharmaceutical Committee at the Ministry of Health in mid February will be approved in June. He said approval for the registration of a New Pharmaceutical should be issued at the same time, enabling Solagran to start selling Ropren at the beginning of the third quarter.