Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines Regulatory authority and organizations are responsible for effective drug regulation required to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public. Discovery/development Team Nonclinical pharmacology and toxicology Team Clinical research Team Regulatory affairs Team Marketing Team Legal Team Management Team After the successful completion of clinical research, if the drug candidate proven satisfactory to be safe and effective for its intended use, then drug sponsor can submit New Drug Application (NDA) to respective regulatory authority in order to get marketing license and start commercial production.

1. Presented by: Ms. Kajal A. Pradhan
Assistant Professor, M. Pharm (Pharmaceutics)
Smt. R. D. Gardi B. Pharmacy College, Nyara, Rajkot

2. Content
 What is Regulatory Affairs?
 Historical Overview of Regulatory
affairs
 Roles & Responsibility of
Regulatory Affairs Department
 Roles & Responsibility of
Regulatory Affairs Professionals
 Regulatory authorities
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Part- 1:

3. Part- 2:
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a) Drug Development Teams
b) Non-Clinical Drug Development
c) Investigational New Drug (IND)
Application
d) Investigator’s Brochure (IB)
e) Clinical research
f) Clinical Research Protocols
g) New Drug Application (NDA)
h) Abbreviated New Drug Application
(ANDA)

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5. What is Regulatory Affairs?
Regulatory Affairs is a profession which has developed from the
desire of governments to protect public health, by controlling
the safety and efficacy of products in areas including
pharmaceuticals, veterinary medicines, medical devices,
pesticides, agrochemicals, cosmetics and complementary
medicines.
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6. • To establish proper legalization covering all products with a
medicinal claim and all relevant pharmaceutical activities,
whether carried out by the public or the private sector.
• To increase worldwide regulatory growth to ensure the
safety of people.
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Cont...

7. Historical overview of Regulatory
Affairs
Some notable cases in the history responsible for
requirement strict regulation for medicine were required
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Cutter Incident
Thalidomide
tragedy
Elixir
Sulphanilamide

8. • In 1955, some batches of polio vaccine given to the public
contained live polio virus, even though they had passed
required safety testing.
• Over 250 cases of polio were attributed to vaccines produced
by one company: Cutter Laboratories. This case, which
came to be known as the Cutter Incident, resulted in many
cases of paralysis.
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9. Cont...
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10. • Thalidomide was first marketed to health professionals as a
sedative. However, its use rapidly increased amongst
pregnant women due to the drug’s ability to alleviate
morning sickness.
• Soon after its rise in popularity, medical professionals began
to note a series of congenital mutations in children born
from mothers who used the drug during pregnancy, resulting
in the thalidomide tragedy known today.
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Cont...

12. Elixir Sulfanilamide Tragedy
• In 1937, S. E. Massengill Company, a pharmaceutical
manufacturer, created a preparation of sulfanilamide
using diethylene glycol (DEG) as a solvent, and called
the preparation "Elixir Sulfanilamide".
• Watkins was unaware that DEG was toxic to humans, even
though there were extant known cases of toxicity and that
studies were published several years prior which
concluded that DEG was a highly nephrotoxic agent and
should be avoided in humans.
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13. 13
Cont...

14. Role and Responsibility of Regulatory
Affairs Department
• The regulatory bodies play a vital role in between the
companies and the government agencies.
• Regulatory affairs department plays a vital role to ensure
the safety and efficacy of the drugs available to the public
in the market.
• RA Department at its heart is all about Collecting,
Analyzing and Communicating the Risks and Benefits
of health care products to regulatory agencies and public
all over the world.
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15. • Their role begins right from development of a product to
making, marketing and post marketing.
• They advice at all stages both in terms of legal and
technical requirements and restrains help companies
save a lot of time and money in developing the product
and marketing the same.
• The regulatory affairs department also handles the drug
pricing, prescribing, and also the special control if any
(narcotics).
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Cont...

16. Responsibility of Regulatory Affairs
Professionals
• Prime responsibilities involves
preparation and presentation
of registration documents to
regulatory agencies
• To obtain and maintain
marketing authorization (MA)
for the products concerned.
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17. • To keep a track on ever changing legislation in all
countries.
• To promote public health and protect the public from
harmful and dubious drugs.
• Their main role is to comply with Safety & Efficacy of
the products as per regulation laid down by the
government.
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Cont...

18. Regulatory Authorities
• Regulatory authority and
organizations are responsible for
effective drug regulation required to
ensure the safety, efficacy and
quality of drugs, as well as the
accuracy and appropriateness of
the drug information available to
the public.
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19. Different Countries Regulatory
authority
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22. • Drug Development Teams
• Non-Clinical / Pre-Clinical
• Investigational New Drug (IND)
Application
• Investigator’s Brochure (IB)
• Clinical research
• Clinical Research Protocols
• New Drug Application (NDA)
• Abbreviated New Drug Application
(ANDA)
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Topic to be covered.......

23. Drug Development Teams:
 Discovery/development Team
 Nonclinical pharmacology and toxicology Team
 Clinical research Team
 Regulatory affairs Team
 Marketing Team
 Legal Team
 Management Team
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24. Stages of Drug Development
 Drug Discovery
 Preclinical Studies
 INDA(Investigational New Drug Application)
 Clinical Studies
 NDA(New Drug Application)
 Post Marketing Surveillance
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25. Pre-clinical/ Non-Clinical
• Pre-clinical trial: A laboratory test for a novel drug or
a new medical device is usually done on animal
subjects, to see if the hoped-for treatment really works
and if it is safe to test on humans.
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26. • Pre-clinical Drug Development involves pharmacological
and toxicological assessment of the potential new drug in
animal models in order to establish its safety and efficacy
before the administration to human volunteers in clinical trial
phase.
• Rodent and non rodent mammalian models are used for
pharmacokinetic profile and general safety, as well as to
identify toxicity patterns.
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Cont...

27. INDA
• After the successful completion of preclinical research, Drug
developer or sponsor, must submit an Investigational New Drug
(IND) application to respective regulatory authority such as
FDA in US, CDSCO in India etc in order to start clinical
research.
• The IND filing is the formal process by which a sponsor
requests approval for testing of a drug in human subjects.
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29. In the IND application, following things are must included :
• Animal study data and toxicity data
• Manufacturing information
• Clinical protocols (study plans) for studies to be conducted
• Data from any prior human research
• Information about the investigator
• Any additional data
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Cont...

30. IB (Investigator’s Brochure)
• The Investigator’s Brochure (IB) is an important document,
of the IND
• The IB is a compilation of the clinical and nonclinical
data on the investigational product that is relevant to the
study of the product in human subjects.
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31. • Its purpose is to provide the investigators and others
involved in the trial with the information to facilitate their
understanding of the rationale for, and their compliance
with, many key features of the protocol, such as the dose,
dose frequency/interval, methods of administration: and
safety monitoring procedures
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Cont...

32. Clinical Trial
• Clinical Phase of Drug Development: Pre-clinical research
provides a basic idea about drug’s safety in animal models,
but it is not a substitute for human subjects. “Clinical
research” refers to studies, or trials, that involve human
subjects to establish the safety and efficacy of drug.
• Clinical trials are part of clinical research that involve human
beings as a volunteer to determine safety and efficacy of
new drug.
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33. Who Conducts Clinical trials?
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• Every clinical study is led by a principal investigator,
who is often a medical doctor. Clinical studies also have
a research team that may include doctors, nurses, social
workers, and other health care professionals.
• In some studies, you may be assigned to receive
a placebo (an inactive product that resembles the test
product, but without its treatment value).
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34. Phases of Clinical Trial
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35. • Informed consent is the process of providing you with
key information about a research study before you
decide whether to accept the offer to take part.
• The process of informed consent continues throughout
the study.
• To help you decide whether to take part, members of the
research team explain the details of the study.
• If you do not understand English, a translator or
interpreter may be provided.
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Informed Constent

36. Clinical Trial Protocols
• The clinical trial protocol is a document that describes how a
clinical trial will be conducted (the objective(s), design,
methodology, statistical considerations and organization of a
clinical trial,) and ensures the safety of the trial subjects and
integrity of the data collected
• Clinical trials follow a plan known as a protocol. The protocol is
carefully designed to balance the potential benefits and risks to
participants, and answer specific research questions.
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37. • A protocol describes the following:
 The goal of the study
 Who is eligible to take part in the trial
 Protections against risks to participants
 Details about tests, procedures, and treatments
 How long the trial is expected to last
 What information will be gathered
 A clinical trial is led by a principal investigator (PI).
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Cont...

38. NDA(New Drug Application)
• After the successful completion of clinical research, if the drug
candidate proven satisfactory to be safe and effective for its
intended use, then drug sponsor can submit New Drug
Application (NDA) to respective regulatory authority in order to
get marketing license and start commercial production.
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39. S- Standard review: For drugs similar to currently available
drugs.
P- Priority review: For drugs that represent significant
advances over existing treatments.
• The NDA application form :FORM NDA 356 h
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The following letter codes describe the review
priority of the drug:

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Review Process of NDA

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43. Pharmacovigilance
As per WHO:
“The science & activities relating to detection, assessment,
understanding & prevention of adverse effects or any
other drug related problem”
"Pharmacovigilance”
(Pharmakon -drug +Vigilare to keep watch)
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45.  Generic Drugs Termed as – “abbreviated”
 because they are generally not required to include
preclinical (animal) and clinical (human) data to establish
safety and efficacy instead, generics applicant must
demonstrate that there product is bioequivalent
 ANDA(Abbreviated New Drug Application) contains
data submitted to regulatory agency for review and
ultimate approval of a generic drug product.
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Review Process of ANDA

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49. Reference
• Reddy GTK, Reddy GNK; Significance of Pharmaceutical Regulatory
Bodies - A Review; PharmaTutor; 2017; 5(8); 15-22.
• D.K Sanghi & Rakesh Tiwal; Role of Regulatory affairs in a Pharmaceutical
Industry; International journal of pharmacy review and research.
• http://www.fda.gov
• Richard A. Guarino and Marcel Dekkar, New Drug Approval Process, 2nd
edition,1987,243-356.
• Remington, "The Science and Practice of Pharmacy”, 21st edition, Volume-
1,965.
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