Subscribe RSSOne enigma is that medicines must now undergo local trials before they can be sold in Russia, regardless of whether they have already undergone trials or been approved elsewhere. The target is to ensure that drugs are backed by high-quality trials that prove their effectiveness in the indigenous population. A few Asian countries have be like rules, but whereas some Asians are thought to metabolize certain drugs in a different way from Europeans, that is not the case for Russians, says Leonid Kokovin, a clinical-trials overseer based in Moscow. “We are statistically like European and American subjects, so the argument for testing on our natives isn't understandable,” he says.
The law also raises ethical concerns because it subjects people to clinical trials that are not expected to supply extra knowledge, Kokovin notes. He suggests that medicines backed by suitable foreign trials should be approved by the Russian authorities, as fancy as they are tracked in post-marketing studies. “That would be much simpler, and wouldn't put such a barrier on the market,” he says.
