It includes information about regulatory bodies, role of drug Regulatory professional, countries with their regulatory bodies, intellectual property rights, terminologies related to DRA, drug approval process, event regarding lack of Drug regulatory affairs

2. Course Structure and content for
PRACTICE SCHOOL ( BP706Ps)
Final year Bpharm (sem VII)
Domain – 8
Drug Regulatory affairs

3. A Review Article by-
Rujuta Namdev Bhor
Final year Bpharm
(1952811823004)
Guided by –
Dr Sushil patil

4. INDEX
• Introduction
• Role of regulatory bodies
• Professionals in drug Regulatory Authority
• Countries with their regulatory bodies
• Intellectual property rights
• Terminologies related to DRA
• Drug approval process
• Events regarding lack of regulatory affairs
• Regulatory bodies in different countries.
• Conclusion

5. INTRODUCTION
• DRUG REGULATORY AFFAIRS-
• Regulatory affairs is also term as government affairs because it follows the rules given by
government authorities to fullfill all the needs of pharmaceutical products.
• Regulatory affairs is nothing but collecting, analysing , communicating, understanding
the risk and benefits of health care products to regulatory agencies and public all over
the world.
• It has broad spectrum covering all aspects of documentation and marketing in the
legalized form.
• Regulatory professional give advise to company both starategically as well as technically
at there highest level for better health care .
• They provide tactical as well as practical advice at top level of their companies to stand
in global market.

6. ROLE OF REGULATORY AFFAIRS AUTHORITIES -
1. Development of new drug product
2. Manufacturing of that product
3. Marketing of the product
4. Post marketing of that product
Regulatory authorities initiated from government to protect public health by
controlling
1. Safety
2. Efficasy
3. Quality.

7. Regulatory authority -
Regulatory authority involve the registration of drug products in repsects of
countries prior to their marketing.
• There are two types of Regulatory bodies –
1. Domestic regulatory affairs (DRA)-
it is basically country originated .
2. International regulatory affairs (IRA)-
It is other than country origine.
Pharmaceutical
Industry
Regulatory affairs
Interface between
Drug regulatory
Authority
(worldwide)

8. Professionals In DRA-
• DRA professionals plays important role in all of this phases from
devlopment of new products to marketing of product .
• DRA professionals have thorough knowledge of domestic regulations
as well as international regulations with its scientific background.
• DRA professionals should also have the updated information in global
pharmaceutical market.
• DRA professionals must actively participate in discussion and co
ordinate team activity to obtain all necessary documents and access
for accuracy.

9. Countries and their regulatory authorities
Çountries Name Of Regulatory Authorities
USA Food and Drug Administration (FDA)
UK Medicines and Healthcare Products
Regulatory Agency (MHRA)
INDIA Central Drug Standard Control Organization
(CDSCO)
CANADA Health Canada
ITALY Italian pharmaceutical Agency
UKRAIN Ministry Of Health
CHINA State Food and Drug Administration
JAPAN Ministry of Health, Labour and welfare
EUROPE European Medicines agency (EMEA)

10. CDSCO-
(Central Drug Standard Control Organization)
• CDSCO is the centrally located drug Regulatory body situated in new delhi .
• The head of CDSCO is dr V.G.Somani. Who is directorate general of India .
• It works under Directorate General Of Health Services Ministry Of Health And
Family Welfare Government of India.
• Vision – To protect and promote public health in India.
• Mission - To safeguard and enhance the public health by assuring safety, efficacy
and quality of drugs,medical devices and cosmetics.
• 379 members are working there.

11. Healthcare Industry , Intellectual Property
Rights (IPR)-
1. Copyright-
Copyright is one of the type of intellectual property rights that gives
its owner exclusively right to Copy , distribute,display there work.
2. Trademark –
. Trademark is also under intellectual property rights It is the symbol
Word Which is legally register.
3. Patent –
. Patent is type of intellectual property rights which give its owner
right to from making, selling, using the inovation .

12. Terminologies related to DRA-
Name Full forms
NDA New Drug Application
INDA Investigational New Drug Application
ANDA Abbrivated New Drug Application
MAA Marketed Authorisation Application
DMF Drug Master File
CMC Chemistry Manufacture And Control
ICH International council of Harmonisation
Orange book Involve approved drug products with therapeutic
equivalence evaluation
CTD Common Technical Document
ASMF Active Substance Master File
CMS Concerned member state
RMS Reference Member state

13. Drug development / Approval process -
Basic research and
Target discovery
Drug
Discovery
Pre-clinical
Testing
IND Submission and
review by FDA
Clinical
Trials
NDA Submission
review by FDA
FDA Approval
Manufacture and
marketing

14. Events Caused due to lack of Awareness
about DRA-
• Banned Artemis Biotech , Hyderabad pharma company –
. FDA found concern there about the API production
This company produced SIMVASTATIN As an API and market in US
market but there is lack of quality which is seen by the USFDA
Committee due to this FDA banned the product .

15. Pfizer Hospira plant-
Pfizer also acknowledge about a week ago that it had temporarily
suspended production at hospira Plant in Chennai, India .
Hospira plant do the production of TB drugs which are marketed in US
Market .
After checking by USFDA found concern there so banned until the
changes are done which are needed.

16. LAXACHEM, Amravati, Maharashtra
• Contaminated Docusate Sodium was seen by USFDA while
investigation
• This Docusate Sodium causes the infection of B-cepacia and
Burkholderia cepacia.
• Due to this cepacia infection there is bacterial resistant to the
antibiotic.

17. Different forms filing by DRA -
1. IND-
It is an application to get approval for conducting a human clinical
trials and shipping of experimental drug for investigation purpose
There are 3 types of application form-
1. Investigator IND
2. TREATMENT IND (life threatning condition)
3. Emergency use IND.

18. Drug Master File (DMF)-
• Submission to FDA which provide confidentiality details information.
1. Facilities
2. Procces used for manufacturing.
3. Packaging
4. Storage of drugs
5. Chemistry,component of drug product.

19. TYPES OF DRUG
MASTER FILE-
Types of DMF Information about DMF
TYPE - 1 Manufacturing site , facilities,operating procedure
,personnel.
TYPE - 2 Drug substance,drug products
TYPE - 3 Packaging meaterial
Type - 4 Excipients,flavoured,colourants ,essense.

20. NDA
• It is an application which filed with FDA to market a new
pharmaceutical drug products for sale in USA.
• APPLICATION – It involves data of animal studies and human
clinical trials.

21. ANDA FILING –
• ANDA means ABBREVIATED NEW DRUG APPLICATION.
• There are 4 types of form-
1. PARA 1 FILING-.
This form is for those drugs which are not having patent.
2. PARA 2 FILING –
This made when drug is already off Patent nor expired.
3. PARA 3 FILING –
. Patent will expire on particular date .
4. PARA 4 FILING-
. Patent is invalid

22. MARKETED AUTHORISATION APPLICATION
(MAA)-
• This application is for new drug in Europe for permission to bring
developed pharmaceutical products to market .
• DRUG MASTER FILE (DMF) is for US country only and ACTIVE
SUBSTANCE MASTER FILE (ASMF) is for European countries .

23. Procedure for drug approval in Europe-
There are 4 type of procedure
1. National procedure –
. This one is for overall drugs for registration,
Req 210 days for access.
2. Mutual Recognition procedure (MRP)-
. It is for allready approved drug in Europe , it takes 90 days for CMF and RMF + 30 days (national phase ).
3. Centralised procedure –
this one for rare disease and innovative medicine,
It takes 210 days + time taken by EU commission
. Commission for decision making .
4. De Centralised procedure -
. This one is for several member state ,
210 days + 30 days ( national phase ).

24. Conclusion -
• Regulatory affairs is not only the registration of drug product but they
gives the practical as well as tactical knowledge to company to stand
in this developing globe.
• Regulatory professionals works as they give proper knowledge of
record keeping, data management, inappropriate scientific
background to company for there growth.
• For the better and healthy lifestyle the regulatory authority works by
improving quality and safety, efficacy of drug product.

25. References -
• Role of regulatory affairs in Pharmaceutical industries,
Sohail Ahmed, Sujata bhati, International journal of Scientific research In science and
technology. Vol 9 , issue -4 ,Pg no 336.
• Overview of drug Regulatory affairs and regulatory profession,
Badjatya jitendra kumar*, International Journal Of Drug Regulatory Affairs,
ISSN:2321-6794.
• https://youtu.be/M_GOym_EuyM
• https://ich.org/
• https://cdsco.gov.in/opencms/opencms/en/Home/

26. Thank you