Indian advisory board proposes waiving phase III for certain drugs
- Under a new proposal from India's Drugs Technical Advisory Board (DTAB), drugs that have already been approved in "well regulated" markets would not have to undertake phase III trials.
- In addition, drug sponsors would have to agree to implement a four-year post-marketing surveillance plan.
- Tthe Central Drugs Standard Control Organization (CDSCO) would also have to get expert input from therapeutic area specialists.
This initiative, which was proposed by India's Drugs Technical Advisory Board (DTAB), is not intended to cover all drugs that are under regulatory consideration in the Indian market.
Rather, the focus is on drugs that would be useful during a national health emergency, as well as rare drugs. This proposal is part of a larger overall effort to reform the drug regulatory system in India.
- Regulatory Affairs Professional Society India Proposes to Waive Phase III Trials for Drugs Approved in a 'Well-Regulated Country' - See more at: http://www.raps.org/Regulatory-Focus/News/2015/02/27/21562/India-Proposes-to-Waive-Phase-III-Trials-for-Drugs-Approved-in-a-Well-Regulated-Country/#sthash.GRYTVVnB.dpuf