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Dr V. G. Somali
Joint Drugs
Controller(India)
CISCO(HQ)
23.02.2017New drug approval
and
Post Marketing
SurveillanceLegal Provisions for permission to Import / Manufacture
of New Drugs
Requirements
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What is new drug approval?
New drug approval is the process by which a pharmaceutical company seeks and obtains approval from the regulatory authorities to bring a new drug to market.
Who is required to file new drug approval?
Pharmaceutical companies are required to file new drug approval applications.
How to fill out new drug approval?
New drug approval applications must be filled out accurately and completely with all relevant information about the new drug.
What is the purpose of new drug approval?
The purpose of new drug approval is to ensure that new drugs are safe and effective for use by the general public.
What information must be reported on new drug approval?
Information such as drug composition, clinical trial data, side effects, and intended use must be reported on new drug approval.
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