The document discusses the new drug approval process. It begins with introducing key terms like new drug and New Drug Application (NDA). It then outlines the objectives of an NDA which are to evaluate the drug's safety, effectiveness, proposed labeling, and manufacturing quality. The document proceeds to describe the two phases of new drug approval - clinical trials and marketing authorization. Key steps involve completing pre-clinical studies, submitting clinical trial applications, conducting Phase I-IV trials, and submitting the NDA which includes all trial data for regulatory review and approval. Ongoing monitoring is also needed after approval.

1. PROCESSING OF NEW DRUG APPLICATION
SUBJECT:- DRA IPR AND QA
SUBMITTED BY:-
DEEPAK KR. YADAV
M.Pharma 2nd Semester
(Y22254010)
SUBMITTED TO:-
Dr. DHARMENDRA JAIN
(Ass. Prof. DOPS)
MR. SUNNY RATHEE
DEPARTMENT OF PHARMACEUTICAL
SCIENCES
Dr. HARISINGH GOUR
VISHWAVIDYALAYA
SAGAR (M.P.)-470003,India
(A Central University)

2. CONTENTS-
• Introduction
• Objectives
• New Drug Approval
• Processing Of NDA
• References

3. Introduction
New Drug-
Drug that has not been declared safe and effective by qualified expert
under the condition prescribed, recommended, or suggested in the and that
may be new chemical formula or an established drug prescribed for use in
new way.
NDA-
An application submitted by the manufacturer of a drug to the FDA - after
clinical trials have been completed - for a license to market the drug for a
specified.

4. Objective of NDA
• Whether the drug's proposed labeling (package insert) is appropriate, and what it
should contain.
• Whether the drug is safe and effective in its propose use, and whether the benefits of
the drug outweigh the risks .
• Whether the methods used in manufacturing the drug and the controls used to
maintain the drug's quality are adequate to preserve the drug's identity, strength,
quality, and purity.
• Safety and effectiveness of drug.

5. New Drug Approval
• To launch a new drug in the Indian market any company/ person/ sponsor/
organization need to get authorization from Drug Regulatory Authority of
India i.e CDSCO and needs to seek permission from DCGI. This is known
as the New Drug Approval Process.
• The New drug approval is of two phase process, The first phase for clinical
trials and second phase for marketing authorization of drug.
• Firstly non-clinical studies of a drug are completed to ensure efficacy and
safety then application for conduct of clinical trials is submitted to the
competent authority.

6. Contd….
• Thereafter, the clinical trial can be conducted(phase I to phase IV).these
studies are performed to ensure the efficacy, safety and optimizing the dose
of drug in human.
• After the completion of clinical studies of the drug, then an application to
competent authority of the concerned country for the approval of drug for
marketing is submitted.
• The competent authority review the application and approve the drug for
marketing only if the drug is found to be safe and effective in human being
or the drug have more desirable effects as compare to the adverse effects.

7. • Even after the approval of new drug, government should monitor its safety
due to appearance of some side effect. When it is used in larger
population.The interactions with other drugs, which were not assessed in a
pre-marketing research trials and its adverse effects.
Contd….

8. New Drug Application Includes
• Everything about drug from pre-clinical data to phase 3 trial data.
• Proposed Labelling.
• Brief description of drug and therapeutic class to which it belongs.
• Chemical Info.
• Animal cology And toxicity.
• Human Pharmacology(Phase 1)
• Therapeutic Exploratory trials (Phase 2)
• Therapeutic Confirmatory trials(Phase 3)
• Regulatory status in other countries.
• Testing Protocol.

10. New Drug Application Forms And Rules

11. References
• https://www.fda.gov/drugs/types-applications/new-drug-application-nda
• LIPSKY, Martin S.; SHARP, Lisa K. From idea to market: the drug approval
process. The Journal of the American Board of Family Practice, 2001, 14.5:
362-367.