The country’s drug controller is planning to waive local clinical trial of drugs meant to treat certain type of cancer, AIDS, hepatitis and rare blood disorders if the drugs are cleared in “well-regulated” countries like the US, Australia, Canada, Europe…
Government looks to fast-track approvals for clinical trials
As the government reviews an overhaul of the drug regulatory process, rules related to clinical trials may be further eased and timelines for approvals shortened to four to six months from around six to eight months now. The central drug…
CDSCO LAUNCHED ONLINE APPLICATION FOR GCT (Global Clinical Trials
notice-dated05-10-2016 CDSCO has published notice that online application for Global Clinical Trial application is live and effective 24 Oct 216, it is mandatory to file application online. Although at present hardcopies of application also needs to be submitted along with…