India Outlines Requirements for CTDs in New Drug Applications

India’s Central Drugs Standard Control Organization hopes to improve approval times for the importation, manufacture and marketing of new drugs by adopting the common technical dossier (CTD) format for new drug applications. According to a draft guidance, the current practice of allowing applicants to use different approaches to organizing data for submissions often results in the omission of critical data or analyses, which in turn leads to unnecessary delays in approvals.
International Pharmaceutical Regulatory Monitor