This project report discusses drug regulatory affairs and its importance. It provides an overview of regulatory departments and professionals, their roles, and necessary qualities. Regulatory authorities from India, the US, European Union, and Japan are examined. The report outlines the drug approval process in each region and highlights literature on regulatory issues faced by pharmaceutical companies. In conclusion, the report emphasizes that regulatory affairs has become essential for pharmaceutical companies due to globalization and the need to navigate varying international regulations and authorities.

1. PROJECT REPORT ON
DRUG REGULATORY AFFAIRS
Submitted in partial fulfilment of requirement
For the award of the degree of
BACHELOR OF PHARMACY
Submitted by:
ABHISHEK SAURABH
ROLL NO: - BPH/1044/2011
Under the guidance of
Dr. Kishanta Kumar Pradhan
Assistant Professor
Department of Pharmaceutical sciences and Technology
Birla institute of technology, Mesra, Ranchi-835215
2015

2. CONTENTS
 Introduction
Literature Survey
Objective and plan of Work
Drug Regulatory Affairs
Importance of Regulatory Affairs
Regulatory department and professionals
Roles of Regulatory Affairs Professionals
 Qualities of Good RA Professional
Regulatory Authorities
 Conclusion

3. Introduction
Pharmaceutical & Clinical Research Industry most regulated among all the
industries.
Every drug before getting approved undergo scrutiny and clinical trials to ensure its
Safety, Efficacy & Quality.
Standards are set by regulatory authorities
RA department acts as a crucial link between company, product and
regulatory authoritires.

4. The Indian pharmaceutical industry is one of the fastest growing industries in India, with a
compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a
higher rate in coming 10 years.
As the pharmaceutical industries throughout the world are moving ahead towards becoming more
and more competitive, these are realizing that the real battle of survival lies in executing the work by
understanding the guidelines related to various activities carried out to give an assurance that the
process is under regulation
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries,
such as pharmaceuticals, medical devices, energy, and banking.
Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals,
medical devices, Biologics and functional foods) most companies, whether they are major multinational
pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments
of Regulatory Affairs professionals

5. Literature Survey
• In 2014, in a setback to the country’s largest drug maker Sun Pharmaceuticals, the US FDA
issued an “import alert” for all products manufactured at its cephalosporin facility located
at Karkhadi, Gujarat. The company manufactures active pharmaceutical ingredients (API)
and formulations in this unit. An “import alert” results in detention without physical
examination of drugs from firms that have not met “good manufacturing practices”.
According to the company, this alert was issued by the US FDA as a follow-up to the last
inspection of the facility, during which some non-compliance of current good
manufacturing practice (cGMP) regulations was identified.
• In 2015, U.S. regulator the Food and Drug Administration banned imports from a Madhya
Pradesh manufacturing plant of generic drug maker Ipca Laboratories Ltd, citing violations
of standard production practices. Ipca suspended shipments to the United States from the
plant at Ratlam in Madhya Pradesh that makes drug ingredients, after the FDA outlined
half a dozen violations, including data integrity issues.

6. • In 2013, Wockhardt Ltd faced a sharp drop in market share and delays in new launch
approvals after a second plant operated by the generic drug maker was hit by the US Food
and Drug Administration's "import alert", effectively a ban. An "import alert" results in the
detention without physical examination of drugs from firms that have not met so-called
good manufacturing practices, according to the FDA website. The latest FDA action against
Wockhardt's Chikalthana plant in western India, one of its key export facilities, comes amid
a slew of regulatory rebukes in recent months, which has wiped off nearly three-quarters
of the company's share value this year.
• In 2014, The US Food and Drug Administration (FDA) warned privately owned drug maker
Cadila Pharmaceuticals Ltd that it was not following quality and manufacturing standards
at one of its plants, which caused impurities in drug ingredients made there. In a warning
letter posted on its website, the FDA said inspectors had found "significant deviations"
from standard manufacturing practices at Cadila Pharmaceuticals' Ankleshwar plant in
Gujarat state. The FDA issued the letter, and gave the company 15 days to respond. If
Cadila Pharmaceuticals fails to take measures to correct the violations, the agency can ban
exports to the United States from the plant.

7. OBJECTIVE :-
To determine whether a regulatory function exists, how it is carried out and What
financial and human resources are available for its implementation.
To propose strategies that can help policy-makers and implementers to improve drug
regulation.

8. Plan of work
Pharmaceutical regulatory affairs and its importance
 Regulatory department and professionals
 Different important regulatory acts
 Regulatory authorities of different countries
 A Comparative study on Drug Regulatory bodies In India, US, European
Union (EU) and Japan
 Explanation of some important terms in regulatory affairs

10. • Stands for Drug regulatory affairs
• Drug regulatory affairs is a dynamic and challenging field in the pharmaceutical industry
• It is an affair between the competent authority and an applicant (company) to manage
life cycle of the products
• Unique mix of science and management to achieve a commercially important goal
• It touches everything relating to drugs from the development to manufacturing and
marketing
WhatisDRA??

11. • RA takes care of : Design = Development Plan, Co-ordination = Writing/
Reviewing/supervising, Construction = Assembling & Submission
management
• It act as bridge between Pharma companies and regulatory agencies
• it involves process of interaction of company with drug regulatory
authorities and internal department of the organizations.
• In present regulatory scenario, company requires experts in regulatory
activities to manage the product life cycle.
• RA Experts are qualified professionals to provide right solution to the
technical problems under the light of laws and regulations.

12. Importance of RA
• Reduction of the time taken to reach market is critical to product’s and the company’s
success ensured by R.A.
• Inadequate reporting of data or release of product with incorrect labelling, may result in
loss of several millions sales unit, reduction in confidence of the investors, patients.
• A good Regulatory Affairs professional will help to maximise the cost-effective use of the
company’s resources.
• This Dept. is first point of contact between the government authorities and the company.
Officials respond better to a company whose representatives are scientifically accurate
and knowledgeable.

13. Company success depends on
reduction of time taken for
a drug to reach market
Inadequate reporting of
data may prevent a
timely positive
evaluation of a
Marketing application
Proper conduct of RA
activities is therefore
of considerable
economic importance
for the company
NO DMF/
DOSSIER
NO REGISTRATION
NO SALE

14. • RA Professionals are employed in pharmaceuticals, medical devices, biologics &
biotechnology, nutritional products and cosmetics.
 They come in contact with pharmacologists, toxicologists, analytical chemists,
pharmacists, medical doctors and statisticians.
 Assimilate information by such specialists.
 Present that information to regulatory authorities.
 Feed-back their opinions to the rest of the company.
Role of RA Professionals

15.  The Regulatory Affairs professionals keep track of the changing legislation in the
regions in which the company distributes its products.
 They advise on :
-Legal and scientific restraints and requirements,
-Collect, collate, and
-Evaluate the scientific data that their R&D Dept. generates.
 Keep up-to-date about international legislation, guidelines and customer practices and
Formulate regulatory submission strategies.
 Handle regulatory and customer inspections, review audit reports and compliance
Arranges consultations and meetings between the firm and government regulatory
agencies.

16. Skills RA Professionals should possess
InfluenceNegotiate
Persuade
Present Communicate articulately
Listen actively
Interpret and consolidate dataIT literate
Work independently and cohesivelyAccuracy
Quality

17. Drug Regulatory Authorities
•Regulatory authorities in the present context may be defined as "The
competent government agency which is responsible for ensuring that
medicines work and are acceptably safe.“
•Every country has its own regulatory authority , which is responsible to
enforce the rules and regulations and issue guidelines for drug
development, licensing, registration, manufacturing, marketing and
labelling of pharmaceutical products.
•These authorities are widening their vision emphasizing more and more
on delivering the public with drug products of high quality, efficacy and
safety.

18. Country Name of Regulatory Authority
• India Central Drug Standards control
organization (CDSCO)
• United States (U.S) Food and Drug Administration (FDA)
• European Union (E.U) European Medicines Evaluation
Agency (EMEA)
• Japan Ministry of Health, Labour and
Family Welfare (MHLW)

19. INDIA

22. Flow Chart for the Drug Approval process in India

23. United States (U.S)
The Food and Drug Administration is responsible for protecting and promoting public health.
Like general drug approval process, FDA’s new drug approval process is also accomplished in two phases: clinical trials
(CT) and new drug application (NDA) approval
The Phases in the FDA Approval Process
Pre-Clinical Phase
In the pre-clinical or drug discovery phase of the approval process, researchers look for potential new compounds
to treat targeted diseases. Once a compound has been identified and refined to a formula that can be tolerated
by humans, its toxicology is tested in animals and livingtissue.
The process takes roughly three and a half years. During this phase researchers look for:
Correct dosage level
How frequently it should be administered
Best delivery system (oral, topical, intravenous, etc.)
Short- and long-term survival of the animals

24. After pre-clinical testing is completed, the company then files an Investigational New Drug Application (IND) with
the FDA.
Fast Track Designation is an expedited review of a drug that is given to a company whose drug or biologic
makes both a product and a marketing claim that addresses an unmet medical need. It can be granted at
any point after the FDA approves an IND.
New Drug Application (NDA)
If the drug proves to be safe and effective, the company then files an NDA with the FDA. NDAs are typically
100,000 pages long and include results of human and animal trials as well as information on how the drug is
manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug.

25. European Union (E.U)
 REGULATORY APPROVAL & SUBMISSION PROCEDURE IN EUROPE (EU)
Pharmaceutical companies of EU use three approval procedures to market their pharmaceuticals.
(A) Centralized Procedure
Centralized procedure allows a pharmaceutical company to market its pharmaceutical product in all 25 member
states, without having to obtain separate approvals from each member state. Applications through the centralized
procedure are submitted directly to the agency. Evaluation by agencies scientific committees takes up to
210 days, at the end of which the committee adopts an opinion on whether the medicine should be marketed or
not. This opinion is then transmitted to the European commission, which has the ultimate authority for granting
marketing authorization in the EU. After the marketing authorization has granted, the marketing authorization
holder can began to make the medicine available to the patients and healthcare professional in the EU countries.
(B) Decentralized Procedure
An applicant can go directly to a national marketing authority to obtain permission to market its product in
that member state and then seek to have other member states accept the marketing approval of the first member
state.

26. (C) Mutual Recognition Procedure (MRP)
The mutual recognition procedure (MRP) is similar to the decentralized procedure with some differences. The mutual
recognition procedure is applicable to medicinal products which have received a marketing authorization in any member
state whereas the decentralized procedure is applicable to those products which were never approved in any member
states of the European Union. The MRP is used to obtain marketing authorizations in various several member states. The
evaluation of application Can be taken within 90 days instead of 120 days (in decentralized procedure). After the grant of
marketing authorization, the product can be marketed

27. So, the drug approval process varies from one country to another. In some countries,
only a single body regulates the drugs and responsible for all regulatory task such as
approval of new drugs, providing license for manufacturing and inspection of
manufacturing plants e.g. in USA, FDA performs all the functions. However in
some counties all tasks are not performed by a single regulatory authority, such as in
India, this responsibility is
divided on Centralized and State authorities. Other issues where the difference
appears are, time taken in evaluation of marketing authorization application,
registration fee, registration process and marketing exclusivity.

28. Conclusion
As globalization of world, geographical barriers have become obsolete. Any
company from any part of the world can be globalized itself and it can carry
out its business in any country. And Pharma industries learned faster about
global needs and carried its business across different companies.
We are knowing that many Pharma companies doing business in millions
and billions in the world. So for carrying business in different countries,
Pharma companies have to fulfil lot of documentation and technical needs of
that countries regulatory bodies.

29. Approval from regulatory bodies is most essential and it can surely change
huge margin of turnover for that company.
Apart from this, Pharma companies have to keep updated on top of the
latest developments within the industry to writing product labels and patent
information. As well as collecting and collating large amounts of information
and preparing licensing submissions, liaising with doctors and scientists,
conducting clinical trials and negotiating with regulatory authorities.
For this purpose now a days all Pharma companies developed separate
division like production, QC, QA and that is DRUG REGULATORY AFFAIRS
(DRA).

30. So from above we can conclude that DRA is todays most necessity of
Pharma Industries. And because of Globalization of the world, it is
most needed area for all national & international Pharma companies.

31. References
 Gopinath E., Bhadauria R.S., Gunjan J., Insha Z.; International Journal of Advanced Research in Pharmaceutical & Bio
Sciences ; 2012; vol.2 (2); 292-301.
 Kumar S., Panwar R., Singh U.; Regulatory Affairs in the Pharmacy Curriculum, International Journal of Research and
Development in Pharmacy and Life Sciences; 2013; Vol.2(6); 690-698
 Ramesh T.; Regulatory Perspective for Entering Global Pharma Markets. Pharma Times; 2011; vol.43(09);15-19.
Khurana G, Jaipuriar N, Indian Pharmaceutical Market, Indian law offices.
Available at: www.indialawoffices.com
 www.fda.gov
 http://www.cdsco.nic.in/forms/Default.aspx
 http://www.raps.org/
 http://www.ijdra.com/

32.  Business World; Wockhardt Plunges After FDA Ban On Another Plant; 27 Nov, 2013.
Available at: http://www.businessworld.in/news/business/pharma/wockhardt-plunges- after-fda-ban-on-another-
plant/1168724/page-1.html
 Business Standards; Sun Pharma hit by US FDA ban on Gujarat plant; March 14, 2014
Available at: http://www.business-standard.com/article/companies/sun-pharma-hit-by-us-fda-ban-on-gujarat-plant-
114031400021_1.html; Accessed on 28 April 2015
 Rahalkar H.; Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs. Pharmaceutical Regulatory
Affairs; 2012; 2167-7689
 T. Rakesh.; Role of regulatory affairs in a pharmaceutical industry; International Journal of Pharmacy Review & Research;
2014; vol.4; 127-131
 Sudhakar Y, Jayaveera K.N.; Novel drug delivery system and regulatory affairs; 2014; vol.2; 315-344
 Lumley C, Walker S; improving the Regulatory Review Process -Industry and Regulatory Initiatives; Dordrecht: Kluwer
Academic Publishers; 1996; 13-19

33. THANK YOU !!!