Introduction to Clinical Research Regulations

Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.

1. Welcome
Introduction to clinical Research Regulations: Understanding
Regulatory landscapes
P.HEMALATHA
PHRM.D 6yr
ID N0:093/05202310/18/2022
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2. Index
• Introduction
•Regulatory bodies in India
•Regulatory frame work in India
•The world wide Regulations
•Understanding Regulatory Landscapes.
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3. Introduction to clinical Research
•Clinical research is a branch of healthcare science that determines the safety
and effectiveness (efficacy) of medications, devices, diagnostic products
and treatment regimens intended for human use.
•Interventions include but or not restricted to drug, cells and other biological
products, surgical procedures, Radiological procedures, Devices, behavioral
treatment, Process-of-care changes, preventive care, etc.
•Synthetic study of new drugs in human subjects to generate data for
discover and/ or verifying.
•The clinical pharmacological(including pharmacodynamics and
pharmacokinetics) effux.
•And/or adverse effects, if the objective of determination safety and/or
efficacy.
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4. Clinical Research Regulations
Why are Regulation important to clinical Research?
•Regulations has been set to Ensure integrity of data collected from clinical
trials which assure the safety, right and welfare of the subject.
•Clinical trials are the only way of establishing the safety and efficacy of any
new drug before its introduction in the market for human use. Clinical trials
(with safeguards) are necessary for introduction of new drugs for a country
like India, considering its disease burden and emergence of new variants of
disease.
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5. •The regulatory bodies need to frame guidelines and regulatory approval
processes on a par with international standards. Many of the new laws, guidance
documents, notifications and initiatives for regulating pharmaceutical industry
were in the charts for quite a long time. Indian regulatory authorities have
started looking into speedy implementation and providing support in terms of
necessary infrastructure and investment.
•CDSCO which comes under the Ministry of health and family welfare Is the
main body which works On development of regulatory Procedures And
standard for drugs, cosmetics, diagnostics and devices. It lays down regulatory
guidence by amending acts and rules; and regulate new drugs approvals. Its
main objective is to standardize clinical research and bring safer drugs to
market.
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6. Clinical Research Regulations in India
•Schedule y allows Clinical trials to be carried out in India.
•India has appropriate provisions to ensure the human subjects used
for the trails are informed Well and their participation is voluntary.
•CDSCOs priorities to enhance the current mechanism
•Establish single window clearance for approvals.
•Fix timelines for each application(2-6 weeks).
•Subject experts-reviewers – internal/external.
•Staff and infrastructure at one site.
•Continuous training for the officers.
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7. Regulatory bodies in India
•Central Drugs Regulatory body Standard Control controlled and Organization
governed by
•
•(CDSCO) drug directorate General of Health Services of Ministry of Health
and Family Welfare which regulates drugs in India
•Drugs Controller Regulatory agency General India (DCGI):
Under the government of India whose function is to assess the quality, safety and
efficacy of a drug.
•Indian Council of Medical Research (ICMR);
Apex body in India that formulates, co-ordinates and promotes biomedical
research
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8. •Drugs consultative committee (DCC);
Provides technical guidance to the central drug standard control organization
•Central Drugs Laboratory (CDL);
National statutory laboratory of the Indian government for quality control of drugs.
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•Drugs Technical Advisory Board (DTAB)
Provides technical guidance to the CDSCO

9. Regulatory frame work in India
•(Text here)
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10. The world wide Regulations
•USA : United States food and drug administration(USFDA)
•INDIA : Central drug standard control organization(CDSCO)
•CANADA : Health Canada – sante canada
•AUSTRALIA : Therapeutic goods administration( TDA)
• UK : Medicine and health care products and regulatory
Agencies (MHRA).
•EUROPE : European medicines agency(EMEA)
•SWITZERLAND : Swissmedic
•JAPAN : Ministry of health and labour welfare(MHLW)
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11. •Regulators desire good proof-of-concept studies, leading to representative clinical trials
that can then, in turn, result in appropriate clinical practice guidelines and performance
measures.
•Regulators are also increasingly focused on sustainability, which may be achievable by
simplifying trials and enrolling representative populations and through the use of real-
world data or drug-product monitoring registries.
Another way to help sustainability is early health technology assessment (HTA)
evaluation.
•Integrating clinical research networks is one way to ensure more efficient trails.
•The patient's voice in particular has become increasingly important to regulators in
defining the value of a medicine, yet incorporating patients' viewpoints into clinical trials
may further increase the complexity of those trials.
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Regulatory landscapes

12. •Regulators have been pushing for increased data sharing to promote efficiency and
ensure continued progress.
•There is a need for new regulatory approaches for combining passive and
experimental data that would meet the needs of the 21
st
century.
•Drug-product monitoring registries enable tracking of longitudinal outcomes and
adverse effects.
•Randomization with a registry enables real-world testing of hypotheses.
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13. Thank You!
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