Unit-II,Unit-II, Chapter 2. Regulatory Authorities and Agencies. B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory). As PCI Syllabus.

1. Unit-II
Chapter 2. Regulatory Authorities and Agencies.
Represented By,
Mr. Audumbar Mali.
(Assistant Professor)
Sahyadri College of Pharmacy Methwade
BP804 ET: PHARMACEUTICAL
REGULATORY SCIENCE (Theory)

2. Regulatory Authorities And Agencies:
1. United States:
National Authority: The Food and Drug Administration (FDA) is
a federal agency of the United States Department of Health and
Human Services, one of the United States federal executive
departments. The FDA is responsible for protecting and promoting
public health through the control and supervision of food safety,
tobacco products, dietary supplements, prescription and over the
counter pharmaceutical drugs, vaccines, biopharmaceutical, blood
transfusions, medical devices, electromagnetic radiation emitting
devices (ERED) cosmetics, animal food and feed and veterinary
products.

3. The FDA is led by the Commissioner of Food and Drugs,
appointed by the President with the advice and consent of the
Senate. The FDA has its headquarters in unincorporated White
Oak, Maryland. The agency also has 223 field offices and 13
laboratories located throughout the 50 states, the United States
Virgin Islands and Puerto Rico.
Organization Chart of FDA: FDA the agency within
the Department of Health and Human Services consists
of nine centre-level organizations and thirteen
headquarters.

5. Type of Applications:
Investigational New Drug Application (IND): Application submitted to FDA
to seek permission to test a new drug or a biologic in human.
New Drug Application (NDA): When the sponsor of the new drug believes that
enough Evidence on the drugs safety and effectiveness has been obtained to meet
FDA’s requirements for marketing approval, the sponsor submits to FDA a New
Drug Application.
Abbreviated New Drug Application (ANDA): An Abbreviated New Drug
Application (ANDA) contains data that, when submitted to FDA's Centre for
Drug Evaluation and Research, Office of Generic Drugs, provides for the review
and ultimate approval of a generic drug product. Generic drug applications are
called "abbreviated” because they are generally, not required to include
preclinical (animal) and clinical (human) data to establish safety and
effectiveness.

6. Biologic License Application (BLA): A biologics license application is a submission
that contains specific information on the manufacturing processes, chemistry pharmacology,
clinical pharmacology and the medical effects of the biologic product.
2 Europe:
National Authority: The European Medicine Agency (EMA) is an agency of the
European Union (EU) in charge of the evaluation and supervision of medicinal products.
Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products
or European Medicines Evaluation Agency (EMEA). EMA was set up in 1995, with funding
from European Union and the pharmaceutics industry, as well as indirect subsidy from
member states. EMA was founded after more than seven years of negotiations among the EU
governments and replaced the Committee for Proprietary Medicinal Products and the
Committee for Veterinary Medicinal Products, though both of these were reborn as the core
scientific advisory committees. The agency was located in London prior to the United
Kingdom’s vote for withdrawal from the European Union, relocating to Amsterdam in March
2019.

8. Type of Applications to EMA:
Marketing Authorization Application (MAA): An application
submitted by a drug manufacturer seeking permission to bring a medicinal
product (a new medicine or generic medicines) to the market.
The European Medicine Agency (EMA) is responsible for the scientific
evaluation of centralized marketing authorization application (MAA). Once
granted by the European Commission, the centralized marketing
authorization is valid in all European Union (EU) Member States, Iceland,
Norway and Liechtenstein.
The particular type of applications are as follows:
Biosimilars, Generic and hybrid applications, Orphan medicines, Pediatric
medicines, Advanced therapy medicinal products, Medicines for use outside
the EU.

9. 3. Australia Regulatory authority:
Therapeutic Goods Administration (TGA).

10. Type of Application:
Investigational drug: IND.
New drugs: New Drug Application (NDA).
Generic drugs: Generic Drug Approval Application.

11. 4. Canada: Regulatory Authority: Health Canada.

12. Type of Applications: New Drugs:
NDS (New Drug Submission),
SNDS (Supplemental New Drug Submission).
Generic Drugs:
ANDS (Abbreviated New Drug Submission),
SANDS (Supplemental Abbreviated New Drug Submission).
5. Japan:
Regulatory Authority of Japan is Pharmaceuticals and Medical Devices Agency,
Its key services include; review of regulatory dossiers. relieve services for
Adverse Health Effects and post Market Safety measures.
Type of Application: Investigational New Drug Application (INDA).
New Drug Application (NDA).
Abbreviated New Drug Application (ANDA).

14. References:
1. A textbook of Pharmaceutical Regulatory Science,
By, Dr. R. Narayana Charyulu,
Dr. Jobin Jose. Nirali Prakashan,
Page No. 2.20 -2.28.
2. A textbook of Pharmaceutical Regulatory Science,
By, Dr. Ashok Hajare. Nirali Prakashan,
Page No. 3.1-3.26.
3. www.google.com.