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REGULATORY AGENCY REPORT

PREPARED BY: Mohammed Salman Khan
Student ID: 13161740

College:University of Technology, Sydney

Contents
 Introduction
 USFDA
 EMA
 USFDA vs EMA
 Conclusion
 References
  Introduction
 Regulatory proceedings in pharmaceutical industry is intended
at protection of human health . Each and every country has its
own regulatory authority , that is responsible to impose the rules
and regulations and issue the guidelines to regulate the drug
development, licencing & registration.
 Drug regulation is the control of drug use by international
agreement and/or by regulatory authorities such as the US Food
and Drug Administration (FDA), the European Medicines
Agency (EMA) and the Japanese Pharmaceutical and Medical
Devices Agency (PMDA) etc.
KEY FUNCTIONS OF DRUG REGULATORY AGENCIES:

 Registration of products (drug evaluation and authorization,

and monitoring of drug efficacy and safety).

 Regulation & Control of promotion of drug and information.

 Licensing of premises, persons and practices.

 Main aim of drug regulation is to guarantee the safety, efficacy

and quality of drugs available to the people .

 The drug regulation comprises of:

 1. Drug Laws

 2. Drug Regulatory Agencies

 3. Drug Regulatory Boards

 4. Quality Control

 5. Drug Information Centers etc.

• Formed: 1906

• Previous agencies: Food, Drug, and Insecticide

Administration (July 1927 to July 1930)
• Administration Federal government of the United States
• Head quarters: 10903 New Hampshire Ave, Silver Spring, MD
20903
• Annual budget:$2.3 billion
• Executive head:Margaret A. Hamburg, Commissioner of Food
and Drugs
• Main agency: Department of Health and Human Services
• Website: fda.gov
• The Food and Drug Administration (FDA or USFDA) is an
agency of the United States Department of Health and Human
Services, one of the United States federal executive
departments.
 It is responsible for safeguarding and promoting public health
by regulating and supervising of food safety, tobacco products,
dietary supplements, prescription and over-the-counter
pharmaceutical medicines, vaccines, biopharmaceuticals, blood
transfusions, medical devices, electromagnetic radiation
emitting devices (ERED), veterinary products, and cosmetics
etc.
  It also implements many other laws, namely Section 361 of the
Public Health Service Act and associated regulations, most of
which are not directly related to food or drugs.
Important legislations of the FDA includes :
• 1902 – Biologics Control Act
• 1906 – Food and Drug Act
• 1938 – Drug, and Cosmetic Act
• 1944 – Public Health Service Act etc.

Now FDA regulates $ 1 trillion worth of products a year.

EUROPEAN MEDICINES AGENCY:

 The EMEA was formed in the year 1995.
 It is a decentralised body of the European Union - headquarters
located in
London.
 It comprises of 25 EU Member States in a network of 42
national competent authorities

Objectives:
• Promotion and protection of public and animal health, through
assessment and supervision of medicines meant for human and
veterinary use throughout the European Union.
• Monitoring the safety of drugs for humans and animals,mainly
through a pharmacovigilance programme and the
establishment of safe limits for residues in food. For the benefit
of public and animal health.
• Provide vital information on human and veterinary medicines in
understandable language
 USFDA
1. The Food and Drug Administration is a
regulating body which is a part of the
Department of Health and Human
Services, USA which is mainly
responsible for promotion and safe
guarding public health by regulating
and supervising safety of food, tobacco
products, dietary supplements,
prescription and over-the-counter
pharmaceutical drugs, vaccines,
biopharmaceuticals, blood transfusions
etc.
- It is a Single governing body .
2. The USFDA is a centralizedbody.
3. It plays its role in safety and security of
many essential areas such as food supply,
cosmetics, dietary supplements and products
that give off radiation.
4. It has a much broader scope as compared to
EMA. USFDA looks closely at monitoring the
Phase IV trials (post marketing surveillance)
and also to check for adverse effect or
reactions.
5.It strictly regulates the clinical trials. An IND
(Investigational New Drug Application) is to
be submitted to the FDA along with the pre-
clinical (Animal testing data) data to obtain
permission to conduct the experimental studies
in humans.
6. After proper clinical trials evidence has been
reported, the pharmaceutical company files an
NDA (New Drug Application) to seek
marketing approval in the member countries.
7. FDA has the authority to recall (cancel the
marketing approval of a drug or drug product
and remove it from the market) if the said
drug or product doesn't meet the requirement
protocols of saftey, quality or efficacy.
Ex: Withdrawal of Ritonavir (Anti-HIV) drug
EMEA
1.The European Medicines Agency (EMA) on
other hand plays role in testing of drugs
developed by the pharmaceutical companies . It
provides scientific protocols for regulation and
guides the manufacturers to assist with the
evaluation of medicines.
- Multiple divisions are involved:
• EMEA
• CHMP
• National Health Agencies
2.The EMEA is a decentralized body.
3. EMA,s main objective is the protection and
promotion of public and animal health, through
the evaluation and supervision of drugs for
human and veterinary use.
4. EMA only deals with medicines or drugs. It is
not concerned with food, cosmetics or medical
devices. In addition to this, EMA does not
regulate the drugs already in the market.
5. It is not responsible for anything related to the
clinical testing (Testing of the new drug in
human volunteers).
6. The EMA does have any role in granting of
approvals. It only gives scientific opinions.
7. It does not have any role in withdrawal of
drugs.
8. In FDA there are no prior notifications given 8. Notifications are given before the inspection is
for conducting inspections to ensure that the done by the inspectors of the local regions to
organizations are complying with the Good ensure that the organizations are complying with
Manufacturing Practice (GMP). the Good Manufacturing Practice (GMP).

9. It withholds all the expenses for inspection. 9. In EU, the MAA applicant/holder cover all the
expenses coming under inspections e.g. expenses
of inspector’s travelling arrangement etc.

10.Single inspector carries out the inspection. 10.Two or three inspectors may together conduct
the inspection

Summary and conclusion:

 FDA and EMA are the organisations that protect and promote
public and animal health, through the evaluation and supervision
of drugs meant for human and veterinary use.
 These two agencies aim at expansion of public’s knowledge of
drugs , medical devices, and cosmetics.
 They, collaborate closely to meet the development standards.
 The Drug regulatory bodies in the United States & Europe are
the most preferred and demanding in the entire world.
 It is the duty of regulatory authorities to make sure that
pharmaceutical companies fall in with laws governing them.
 Further they are legislations that require drugs to be developed,
tested, and manufactured in accordance to the guidelines so that
they are safe and patient’s well - being is ENSURED.
 REFERENCES:
• U.S. Government Accountability Office. Clas-ses of Devices.
Publication No. 21 USC 360c(a);2006 ed. Washington, DC: U.S. Govern-
ment Printing Office, 2006.
• Guideline on process validation for finished products information and
data to be provided in regulatory submissions, European Medical
Agency, Feb-2014.
• https://www.fda.gov/downloads/drugs/guidances/ucm080602.pdf