In an unusual move prompted by an enormous second wave of infections, India is accelerating approvals for COVID-19 vaccines granted emergency use authorizations by other selected regulators or on the WHO’s emergency use list without a local bridging study. While this seems a prelude to permitting private sales, where will the supplies come from?
With a second wave of COVID-19 hitting India like a tsunami, the government has taken an unprecedented decision of accelerating approvals for vaccines minus a prior bridging study, though a post-approval parallel bridging trial is still required.
The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) recommended the move, which makes vaccines which have received emergency...
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
Drugs in specific categories that have passed regulatory muster in certain advanced markets, including the US and Japan, will be eligible for trial waivers in India, raising sponsors’ hopes for an accelerated and more streamlined approval process in the country.
Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.
India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
