This document provides an overview of regulatory affairs and the new drug development process. It defines regulatory affairs as a profession focused on collecting, analyzing, and communicating risk-benefit information of healthcare products to regulatory agencies. The new drug development process involves discovery, pre-clinical studies, investigational new drug application, clinical trials, new drug application, and post-marketing activities. Key goals of regulatory affairs include protecting human health, ensuring safety and efficacy, and providing accurate product information.

1. Presented by:
Anil k. Pawar
B.Pharm 6th semister
Guide by:
Dr.Vitthal. J. chaware
M.Pharm,Ph.d

2. INDEX:
 Definition
 New drug development from discovery flow chart
 IND:investigational new drug application
 Clinical protocol
 Pre-ind meeting
 CDER: central drug evaluation and research
 NDA:new drug application
 ORIGIN OF REGULATORY AFFAIR
 GOALS OF RA PROFESSION
 ROLES OF RA PROFESSION
 ABBREVIATION NAD ITS FULL FORM

3. DEFINATION:
 Regulatory affair is a comparatively new profession which
developed from of government to protect public health by
controlling the safty and efficasy product in areas including
pharmacutical,veternary medicines ,medical
devices,pesticides,cosmetic and complimentary medicines.
 RA proffesion at its heart is all about collecting, analysing
and comunicating the risk and benefit ofhealth care product
to regulate agencies and public all over the world.
 RA profession can be defined as government affairs ,for new
drug marketing the pharmacutical company creosses the
different scientific evidence through FDA and NDA.

4. REGULATOY AFFAIR:
The new drug devlopment from discovery through clinical and priclinical studies as folllow;

5. The new drug devlopment from discovery through clinical and priclinical
studies as folllow;
• New chemical entry:
source-
1. Molecular synthesis
2. Molecular modifications
3. Isolation from plant
• Pre-clinical studies.
• include-
1. Chemistry
2. Physical property
3. Biological property

6. • Ind-investigational new drug
application.
Include-
1. Submission
2. FDA review
• Chemical trials
1. Phase1
2. Phase2
3. phase3
• Pre-clinical studies
1. Long terem animal toxicology
2. Product formulation
3. Manufacturers and control
4. Package and label

7. NDA- new drug application
1. Submission
2. FDA review
3. Pre- approval plant inspection
4. FDA action
• post-marketing
1. phase 4 clinical studies –pharmacology and
toxicological
2. Additional indications
3. Product defects reporting
4. Product line extension
 FDA and NDA indicate that the drug or drug product is safe and effective for
clinical indications shows the scientific evidence successfully demonstrated.

8. IND-investigational new drug
application
 Under food ,drug and cosmetic act the sponsor of the drug fillend with IND and FDA.
 The sponsor of IND take responsibility and initiate clinical investigation.
 After submission of IND ,the sponsor must delay the use of drug in human being not less than 30 days
from FDA.
 FDA notify sponsor that result at its review of the submission.
Content of IND-
1. Name address and mob.no of sponsor.
2. Name and title of perosn for conduction.
3. Name and yitle of person responsible for reviews of evolution and information.
4. Name and contact of any research organization involve in study.
5. Identification of phase.
6. Name of drug,structure,molecular formula.
7. Descriptions about investigational plan.
8. Pharmacological and toxicological information.

9.  The clinical protocol-
 It is the part of IND.
1. Purposes and objectives of study statement.
2. Investigational plan ,groups,method etc…
3. Estimation numbers of patient are involved in study.
4. Descriptions about dose-administration route,dose level ,dose duration.
5. Clinical procedure and laboratory test.
6. Name ,address of investigator.
7. Approval of IRB(investigational review board).
 Pre-ind meeting:
 In which meeting FDA advice sponsor which including additional deta to support investigational plan,
design of clinical trials.
 IND nad FDA submission transfer to CDER(Central drug evaluation and research)

10. • CDER- central drug evaluation and research.
 It include following evaluations:
1. Office of drug evaluation 1
 Division of nurology product
 Division of psychiatry product
2. Office of drug evaluation 2
 Division of pulmonary drug
 Division of endocrine drug
 Analgesia,anaesthesia product
3. Office of drug evaluation 3
 Division of GIT product
 Reproductive drug product

11. • NDA: new drug application
 In FDA meeting discuss the content format of drug of NDA.
 The purpose of NDA is to gain permission to marketing the drug product in
united state.
Content of NDA-
It include:
1. Application form fill- name , address, date, signature etc..
2. Chemical, proprietary name, non-proprietary code of drug.
3. Summary application of product.
4. Statement reagarding marketing of drug.

12. • Origin of regulatory affair:
1. Elixir sulfanilamide prepared using DEG(a poison) as solvent resulted in the
death of more than 100 people in USA in 1937s.This incident lead to the
passing of the 1938s federal food, drug and cosmetic act in USA.
2. Thalidomide use by pregnant women for treating morning sickness was linked
to the cause of birth deformities in more than 10,000 children in late 1950s
and early 1960s.
3. This incident led to the kefauver-Harris Amendment to the
federal food,drug and cosmetic act.

13. Goals of RA as profession:
1. Protection of human health
2. Ensuring safety,efficacy and quality of drug
3. Accuracy of products information.

14. • Roles of RA professionals:
1. Prepration of organise and scientifically valid NDA, ANDA, INDA, MAA
submission.
2. Ensure adherence and complianse with all application GMP, ICH,GCP, GLP
guidelines regulations and laws.
3. Providing expertise and regulatory intelligence in translating regulatory
requirements into practical workable plans.
4. Advising the companies on regulatory aspect and climate that would affect
the proposed activities.

15. Full form of the abbreviation:
1. NDA- New drug application.
2. INDA-Investigational new drug application.
3. DMF- drug master file.
4. MAA- marketing authorisation applications.
5. ASMF- active substance master file.
6. GCP- good clinical practice.
7. GLP- good laboratory practice.
8. RA: Regulatory affairs