Overview of Regulatory EnvironmentOverview of Regulatory Environment
in USA, Europe & Indiain USA, Europe & India
Dijo Mathew JohnDijo Mathew John
Pharm.D Post BaccalaureatePharm.D Post Baccalaureate
Need For Therapeutic Good RegulationNeed For Therapeutic Good Regulation
Protect health and safety of population.
By ensuring the safety, quality and efficacy of therapeutic
goods covered under the scope of regulation.
Clinical Research Regulation in USAClinical Research Regulation in USA
Food & Drug AdministrationFood & Drug Administration
The US FDA is a scientific, regulatory and public
health agency under the United States Department
of Health and Human Services.
It is led by the Commissioner of Food and Drugs,
appointed by the President with the advice and
consent of the Senate.
Comprised of several offices and centers.
Primary Responsibility of FDAPrimary Responsibility of FDA
For protecting and promoting public health through the
regulation and supervision of food safety, tobacco
products, dietary supplements, prescription and over-the-
counter pharmaceutical drugs (medications), vaccines,
biopharmaceuticals, blood transfusions, medical devices,
electromagnetic radiation emitting devices (ERED),
veterinary products and cosmetics.
Agency scientists evaluate applications for new human drugs
and biologics, complex medical devices, food and color
additives, infant formulas and animal drugs.
The FDA monitors the manufacture, import, transport, storage
and sale of about $1 trillion worth of products annually.
Centre for Drug Evaluation and ResearchCentre for Drug Evaluation and Research
CDER is one of the centers of US FDA that
Reviews NDAs and ANDAs for their safety and efficacy
manages US cGMP regulations for pharmaceutical
Review advertising and promotion of drugs
collects and analyses safety data about pharmaceuticals that
are already on the market.
Selected regulations and guidance
for drug studies
Code of Federal Regulations (CFR)
CFR Title 21: clinical trials related regulations. (revised
frequently and published yearly):
Part 11: Electronic records
Part 50: Protection of human subjects
Part 54: Financial disclosure by clinical investigators
Part 56: Institutional Review Boards
Part 312: Investigational new drug application
Part 314: Applications for FDA approval to market a new drug
New Drug Approval Process at FDA
1. Sponsor/FDA Meetings (Pre-IND)
2. Submission of IND to FDA
3. Sponsor/FDA Meetings (End of Phase 2)
4. Accelerated Drug Review
5. Parallel Track
6. Clinical Hold Decision
7. Notification to Sponsor (i.e for deficiencies)
8. Sponsor/FDA Meetings (Pre-NDA)
9. New Drug Application
10. Final Meetings with Sponsor
11. Permission for marketing
12. Post marketing review
Clinical Research Regulation in Europe – TheClinical Research Regulation in Europe – The
European Agency for the Evaluation ofEuropean Agency for the Evaluation of
Medicinal Products (EMEA)Medicinal Products (EMEA)
Decentralized scientific body of the European Union
Protection and promotion of public and animal health through
the evaluation and supervision of medicines for human and
Scientific opinions of the agency are prepared by 3 committees:
CPMP: medicines for human use
CVMP: veterinary medicines
COMP: designation of orphan medicines for rare diseases
Clinical Research Regulation in UK – Medicines &Clinical Research Regulation in UK – Medicines &
Healthcare products Regulatory Agency (MHRA)Healthcare products Regulatory Agency (MHRA)
MHRA – competent authority of authority for the medical
devices and the Licensing Authority for pharmaceuticals
advised by Committee on Safety of Medicines (CSM)
Key Activities of MHRA
Regulating medical devices.
Licensing of medicines before marketing and subsequent
Regulation of clinical trials.
Operating adverse incident reporting system for medical devices.
Issuing safety warning.
Responsibility for reporting, assessment and communications of
Monitoring of medicines and acting on safety concerns after
Evaluating medical devices to inform purchasing and encourage safe
Managing the General Practice Research Database (GPRD).
Setting quality standards for drug substances through the ‘British
Providing advice and guidance on medicines and medical devices.
Drug Regulatory System in IndiaDrug Regulatory System in India
Health is in concurrent list of Indian Constitution
It is governed by both central and state governments
Clinical Research Regulation in India –Clinical Research Regulation in India –
Drug Controller General of India (DCGI)Drug Controller General of India (DCGI)
Legislation is enforced by Central Govt (Dept of Chemicals
and Fertilizers, Ministry of Chemicals and Petrochemicals).
Drug Controller General of India (DCGI) under Central drug
Standard Control Organization (CDSCO) has prime
responsibility for regulating Clinical trials in India.
DCGI: matters related to product approval and standards,
clinical trials, introduction of new drugs and import licenses
for new drugs.
Approvals for setting up manufacturing facilities, obtaining
licenses to sell and stock drugs are provided by the State
2 drug organizations to exercise control over drugs:
Central Drug Standard Control Organization (CDSCO)
State Drug Control Organizations
Central Drug Standard Control OrganizationCentral Drug Standard Control Organization
Controlling the quality of imported drugs.
Co-ordinating the activities of the States and advising them
on matters relating to the uniform administration of the Act
in the country.
Laying down Rules and ancillary provisions of Drugs
Control and standards of drugs.
Controlling the quality of drugs moving in inter-state
commerce jointly with Drug Control Organizations.
Granting approval to ‘New Drugs’ proposed to be imported
or manufactured in the country.
Controlling the quality of drugs which are exported.
Arranging meetings of 2 statutory bodies, DTAB and DCC .
Drugs Technical Advisory Board (DTAB): Technical
experts and advises the Central and State Governments on
all technical matters arising out of the enforcement of
Drug Consultative Committee (DCC): To ensure that the
Drug Control measures are enforced uniformly in all
Genetic Engineering Approval Committee (GEAC):
authority to approve rDNA pharmaceutical products.
Assess the bio-safety/environmental product.
Clinical Trials Guidelines in IndiaClinical Trials Guidelines in India
The guidelines that govern the conduct of Clinical
trials in India include:
• Schedule Y of Drugs and Cosmetics Act, 1940.
• Ethical Guidelines for Biomedical Research on
Human Subjects, 2000.
• Good Clinical Practices, 2001.
Schedule Y of Drugs and Cosmetics Act, 1940Schedule Y of Drugs and Cosmetics Act, 1940
Requirement and guidelines on clinical trials for
import and manufacture of new drug in India.
Recommendations for carrying out Clinical Trials in
• The clinical trials required to be carried out in the country
before a new drug is approved for marketing depend on the
status of the drug in other countries.
• Phase III trials are usually required for the drugs which are
already approved/marketed in the country of origin.
If the drug is not approved/marketed, trials are
generally allowed to be initiated at one phase earlier
to the phases of trials in other countries.
For new drug substances (IND) discovered in other
countries phase I trials are not usually allowed to be
initiated in India, unless phase I data from other
countries are available.
If the drug is of unmet therapeutic need, such trials
may be permitted even in the absence of phase I data
from other countries.
For new drugs having potential for use in children,
permission for clinical trials in the pediatric age
group is normally given after phase III trials in adults
However, if the drug is of value primarily in a disease
of children, early trials in the pediatric age group may
Application for permission to conduct clinical
trials is made to the office of DCGI in Form 44.
Permission to import drug may be obtained by
applying in Form 12 for a test license.
Permission to carry out clinical trials with a new
drug is issued in Form 11 along with a test license
Data requirements under schedule YData requirements under schedule Y