USFDA guidelines for CBER, CDER and PIC for the regulated and non regulated drug products

1. Roshan khetade
Department of Quality assurance
Smt. Kishoritai Bhoyar College of Pharmacy,
Kamptee

2. Content
 Introduction
 Organization of FDA
 Responsibility of FDA
 Legal Authority of FDA
 Mission of FDA
 What USFDA regulates
 What USFDA does not regulate
 What is CDER
 What is CBER
 Introduction of PIC
 Objective and role of PIC
 Advantages of PIC

3. INTRODUCTION
 The Food and Drug Administration is an agency of the United States
Department of Health and Human Services one of the united states
federal executive department.
 The FDA is responsible for protecting and promoting public health
through the regulation and supervision of food safety, tobacco
product ,dietary supplement ,prescription and over-the-counter
pharmaceutical drugs, vaccines, biopharmaceutical, blood
transfusion, medical devices, electromagnetic radiation emitting
devices (ERED), veterinary products and cosmetics.
 The FDA also enforces other laws, notably section 361 of the Public
Health Service Act and associated regulation, many of which are not
directly related to food or drugs.
 These include sanitation requirement on interstate travel and control
of disease on products ranging from certain household pects to
sperm donation for assisted reproduction.

4. ORGANIZATION OF FDA
 FDA consists of six products centers, one research center, and two office-
 Center for consists Biologics Evaluation and Research –which regulate the
products such as vaccines, blood, gene therapy.
 Center for Devices and Radiological Health- which regulate medical
devices ranging from thermometer to kidney dialysis machines, electronic
products given radiation such as microwave oven.
 Center for Drug Evaluation and Research – which regulate over-the –
counter and prescription medications.
 Center for Food Safety and Applied Nutrition – which regulate most foods,
meat and food additives, dietary supplement , and cosmetics.
 Center for Tobacco Products –which regulates cigarettes, cigarette tobacco,
and smokeless tobacco.
 Center for Veterinary Medicine- which food and drugs and devices used in
pects, farm animal, and other animal.

5.  National Center for Toxicological Reseach - which supports
FDA products centers by providing innovative scientific
technology, training, and technical expertise.
Office of the Regulatory Affairs- which provides leadership and
direction to FDA products center, research center, and office of
Regulatory Affairs.

6. RESPONSIBILITY OF FDA
 Protecting the public health by assuring that foods are safe, wholesome,
sanitary and properly labeled human and veterinary drugs and vaccines and
other biological products and medical devices intended for human use are
safe and effective.
 Protecting the public from electronic products radiation.
 Assuring cosmetics and dietary supplements are safe properly labeled.
 Regulating tobacco products.
 Helping the public get the accurate science based information they need to
use medicines, devices ,and food to improve their health.
 In june 1906, president Theodore Roosevent singed into law the food and
drug act also known as the ‘’Wiley Act’’ after its chief advocate.
 The act also banned ‘’Misbranding’’ of food and drugs .the responsibility
for examining food and drugs for such ‘’adulteration or misbranding’’ was
given to Wiley USFDA Bureau of Chemistry.

7. LEGAL AUTHORITY OF FDA
 The other significant law enforced by the FDA include the Public Health Service Act
parts of the Controlled Substances Act, the Federal Anti- Tampering Act as well as many
other. In many cases responsibilities are shared with other federal agencies.
 Important enabling legislation of the FDA includes:
 1902- Biologics Control Act
 1906- Pure Food and Drug Act
 1938- Federal Food, Drug and Cosmetic Act
 1944- Public Health Service Act
 1951- Food, Drug and Cosmetics Act Amendements
 1962- Food, Drug and Cosmetics Act Amendements
 1966- Fair Packaging and Labeling Act
 1976- Medical Device Regulation Act
 1987- Prescription Drug Marketing Act
 1988- Anti-drug Abuse Act

8.  1990- Nutrition Labeling and Education Act
 1992- Prescription Drug User Fee Act
 1994- Dietary Supplement Health and Education Act
 1997- Food and Drug Administrative Modemization Act
 2002- Bioterrorism Act
 2002- Medical Device User Fee and Modemization Act
 2003- Animal Drug User Fee Act
 2007- Food and Drug Administration Amendments Act
 2009- Family Smoking Prevention and Tobacco Control Act

9. MISSION OF FDA
 To promote the Public Health by promptly and efficiently reviewing
clinical research and taking appropriate action on the marketing of
regulated products in a timely manner.
 With respect to such products, protect the public health by ensuring
that the food are safe, Wholesome, sanitory, and properly labelled,
human and veterinary drugs are safe and effective.
 The public health and safety are protected from the electronic
product radiation.
 There is reasonable assurance of the safety and effectiveness of
devices intended for human use.
 Participates through appropriate process with representatives of other
countries to reduce the burden of regulation , harmonize regulatory
requirements and achived appropriate arrangements.

10. WHAT USFDA REGULATES
 Biologics
 Food Additives
 Dietary supplements
 Product standards and developed improved testing methods
 Cosmetics
 Labeling
 OTC and prescription drug labeling
 Drug manufacturing standards
 Foods
 Safety of all food products (meat and poultry)
 Medical devices from simple items like tongue depressors, to
complex technologies such as heart pacemakers.

11.  Drug (OTC and prescription drug)
 Radiation Emitting Electronic products
 Radiation safety performance standards for microwave
ovens, television receivers, diagnostic x-ray at equipments
and laser products, ultrasonic therapy equipment, mercury
vapour lamps.
 Veterinary drug and devices.

12. WHAT USFDA DOES NOT REGULATE
 Advertising
 Alcohol beverages
 Consumer products
 Drug and Abuse
 Health Insurance
 Meat and Poultry
 Pesticides
 Restaurants and Grocery stores
 Water

13. WHAT IS CDER
 The Center for Drug Evaluation and Research (CDER, pronounced
‘’see-der’’) is a division of the U.S. Food and Drug Administration
(FDA) that monitor most drug as defined in the Food, Drug and
cosmetic Act.
 Some biological products are also legally considered drug, but they
are covered by the Center for Biologics Evaluation and Research.
 The center review application for brand name, gereric, and over the
counter pharmaceutical, managers US current Good Manufacturing
Practices (cGMP) regulations for pharmaceutical manufacturing.
 CDER reviwe new drug application to ensure that the drug are safe
and effective. Its primary objective is to ensure that all prescription
and over the counter (OTC) medication are safe and effective when
use as directed.

14. WHAT IS CBER
 Center for Biologics Evaluation and Research (CBER) is the
Center within FDA that regulates biological products for
human use under applicable federal law, including the Public
Health service Act and the federal Food, Drug and Cosmetic
Act.
 CBER protects and advances the public health by ensuring that
biological products safe and effective and available to those
who need them CBER also provides the public with
information to promote the safe and appropriate use of
biological products.
 What products does CBER regulate.
CBER regulate an array of diverse and complex biological
products, both Investigational and licensed, including.

15.  Allergenics
 Blood
 Devices
 Gene therapy
 Human Tissues and Cellular Products
 Vaccines
 Xenotransplantation products.

16. INTRODUCTION OF PIC
 PIC (Pharmaceutical Inspection Convention) was established
in 1970 by EFTA (European Foreign Trade Association) under
the title ‘’The Convention for the Mutual Recognition of
Inspections in respect of the Manufacturing of Pharmaceutical
Products.
 PIC is a combine term used for the execution of activities of
Pharmaceutical Inspection Convention and Pharmaceutical
Inspection Co-operation Scheme.
 PIC was established to harmonize, Educate, and update aspects
relating to Good Manufacturing Practices among member
countries. PIC also a body that even harmonized relation
among regulatory authorities and governments.

17. OBJECTIVE And ROLE Of PIC
 The main objective is to harmonize Good Manufacturing
Practice requirements bring about uniform mutual recognition
inspection, educate and exchange information, among different
countries and attain mutual confidence of drug regulatory
authorities.
 The key issues like duplication of Inspections, licensing
procedure, expenditure and licensing can be overcome by one
time procedures.
 The role of PIC scheme is to safe guard public health by
providing good quality medicines by bringing a harmonization
in Good Manufacturing Practice among countries.

18. Advantages of PIC
 PIC brings about an international harmonization among
countries with relating to Good Manufacturing Practices,
quality maintenance system of medicinal products.
 In addition to this Implementation of high standards of quality
along with mutual understanding among member is achived.
 PIC brings about a single network system relating to GMP of
medicinal products.
 It helps member regulatory authorities in sharing facilitating,
recalling, concluding aspects relating to manufacture, quality
and inspection system among inspectorates, pharmaceutical
industries.