Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Development

1. Name : Anant Nag
ID: MPH/10016/21
SUBJECT :SEMINAR /ASSIGNMENT
BRANCH: PHARMACEUTICAL QUALITY ASSURANCE

2.  INTRODUCTION
 KEY FUNCTIONS OF DRUG REGULATORY AGENCIES
 MAIN FOCUS OF DRUG REGULATION
 REGULATORY AGENCIES OVER THE WORLD
 INTERNATIONAL REGULATORY AGENCIES
 DRUG REGULATORY SYSTEM IN INDIA
 FUNCTION OF CDSCO
 ROLE OF DRUG REGULATORY AGENCIES
 Conclusion
 Bibliography

3. Regulatory authority and organizations are responsible in effective
drug regulation required to ensure the safety, efficacy and quality of
drugs, as well as the accuracy and appropriateness of the drug
information available to the public.
Regulatory bodies provide strategic, tactical and operational direction
and support for working within regulations to expedite the
development and delivery of safe and effective healthcare products to
individuals around the world.

4. PRODUCT REGISTRATION
REGULATION OF DRUG MANUFACTURING IMPORTATION,AND DISTRIBUTION
ADVERSE DRUG REACTION MONITORING
LICENSING OF PREMISES & PERSONS & PRACTICES
MAIN GOAL OF THE AGENCY IS TO GUARANTEE THE SAFETY,EFFICACY AND QUALITY
OF THE AVILABLE DRUG PRODUCT

5. DRUG
REGULATION
QUALITY
CONYTROL
DRUG LAWS
DRUG
REGULATION
BOARDS
DRUG
REGULATORY
AGENCY
DRUG
INFORMATION
CENTER

6.  Every country has its own regulatory authority, which is responsible to
enforce the rules and regulations and issue the guidelines to regulate
drug development process , licensing, registration, manufacturing,
marketing and labeling of pharmaceutical products.

7.  USFDA(USA),
 MHRA(UK),
 TGA(Australia),
 CDSCO(India),
 HEALTH CANADA(CANADA),
 MCC(South Africa),
 ANVISA (Brazil) ,
 EMEA (European Union),
 SFDA (China),
 NAFDAC(Nigeria),
 MEDSAFE(Newzeland),
 MHLW(Japan),
 MCAZ(Zimbabwe),
 SWISSMEDIC(Switzerland),
 KFDA(Korea),
 MoH (Sri Lanka)
THE FEW REGULATORY AGENCIES AND ORGANIZATIONS ESTABLISHED IN RESPECTIVE COUNTRIES ARE

8.  World Health Organization (WHO),
 Pan American Health Organization (PAHO),
 World Trade Organization (WTO),
 International Conference on Harmonization (ICH),
 World Intellectual Property Organization (WIPO)
These are some of the international regulatory agencies and organizations which also play
essential role in all aspects of pharmaceutical regulations related to drug product
registration, manufacturing, distribution, price control, marketing, research and
development, and intellectual property protection.

9.  The major challenges of these regulatory agencies and organizations
around the world are to ensure the safety, quality and efficacy of
medicines and medical devices, harmonization of legal procedures
related to drug development, monitoring and ensuring compliance
with statutory obligations .
 They also play a vital role to ensure and increase regulatory
implementation in non-regulated parts of the world for safety of
people residing there.

10. CENTRAL DRUG STANDARD CONTROL ORGANIZATION(CDSCO)
MINISTRY OF HEALTH WELFARE(MHFW)
INDIAN PHARMACEUTICAL ASSOCIATION(IPA)
DRUG TECHNICAL ADVISORY BOARD(DTAB)
PHARMACY COUNCIL OF INDIA(PCI)
CENTRAL DRUG TESTING LABORATORY(CDTL)
INDIAN PHARMACOPEIA COMMISSION(IPC)
NATIONAL PHARMACEUTICAL PRICING AUTHPORITY(NNPA)

11.  To approve license to the various manufacturing of certain categories
of drug as central licensing approving authorities i.e, for blood banks,
large volume parentral and vaccines and sera.
 To regulate the standard of the imported drug products.
 Working relating to the drug technical advisory board (DTAB)
 Testing of Drug by central drug lab.
 Publication of the indian pharmacoeia

12.  As the pharmaceutical industries throughout the world are moving
ahead towards becoming more and more competitive, regulatory
agencies are being established in various countries across the globe.
 Regulatory authority and organizations are responsible in effective
drug regulation required to ensure the safety, efficacy and quality of
drugs, as well as the accuracy and appropriateness of the drug
information available to the public.
 Regulatory bodies provide strategic, tactical and operational direction
and support for working within regulations to expedite the
development and delivery of safe and effective healthcare products to
individuals around the world.

13.  Regulatory agencies and organizations around the world need to
ensure the safety, quality and efficacy of medicines and medical
devices, harmonization of legal procedures related to drug
development, monitoring and ensuring compliance with statutory
obligations. However the need of the hour is
 More centralized procedures in drug regulation
 Harmonization of regulatory norms
 Strengthening the regulatory authorities

14. 1.
Rohilla , Dhulichand ; Dureja , Harish Dr., New Drug Approval Process: Regulatory View,
Pharmainfo.net, 2010.(assessed on Sept 5th 2011).
Governement and regulatory bodies around the world,
pharmweb.net/pwmirror/pwk/pharmwebk.html.(assessed on Sept 8th 2010)
2. Meadows, M. The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective
(2002). fda.gov/fdac/features/2002/402_drug.html (assessed on Sept. 10th 2011)
3. Geetanjali Sengar*, Pranab Tripathy,Drug Regulatory Affairs Dept.Belco Pharma, 515,
Modern Industrial Estate,Bahadurgarh-124507(Haryana), India. 27 June
2012 (https://www.pharmatutor.org/articles/pharmaceutical-regulatory-agencies-and-
organizations-around-world-scope-challenges-in-drug-development)
4. Priyanka Chakote,Drug Regulatory Agencies,
(https://www.slideshare.net/PriyankaChakote1/drug-regulatory-agencies?qid=9b6b3171-
ca16-4090-b2ed-ba15f350df5e&v=&b=&from_search=3),