Regulations and Curriculum –M.

Pharm

PHARMACEUTICAL REGULATORY AFFAIRS (MRA)

GOOD REGULATORY PRACTICES (MRA 101T)

Scope
This course is designed to impart fundamental knowledge on various Good
Regulatory Practices viz., cGMP, GLP, GALP and GDP for Pharmaceuticals,
Cosmetics, Food & Nutraceuticals, Medical devices, In-vitro Diagnostic Medical
Devices (IVDs) and biological products and understand the rationale behind these
requirements and will propose ways and means of complying with them.

Course Outcome
At the end of the course students will be able to…
CO1 Prepare checklists and SOPs for various good regulatory practices.
CO2 Develop good regulatory practices in the healthcare and related
industries
CO3 Demonstrate a plan for the readiness and conduct of audits and
inspections.
CO4 Categorize the key regulatory and compliance elements with respect to
GMP.
CO5 Categorize the key regulatory and compliance elements with respect to
GLP.
CO6 Categorize the key regulatory and compliance elements with respect to
GALP.
CO7 Categorize the key regulatory and compliance elements with respect to
GDP.
CO8 Describe the quality management system in the Pharmaceutical
Industry.

Units Contents Hours

1 Current Good Manufacturing Practices: Introduction, US cGMP 12
Part 210 and Part 211.EC Principles of GMP (Directive 91/356/EEC)
Article 6 to Article 14 and WHO cGMP guidelines GAMP-5; Medical
device and IVDs Global Harmonization Task Force(GHTF) Guidance
docs.

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2 Good Laboratory Practices: Introduction, USFDA GLP Regulations 12

(Subpart A to Subpart K), Controlling the GLP inspection process,
Documentation, Audit, goals of Laboratory Quality Audit, Audit tools,
Future of GLP regulations, relevant ISO and Quality Council of India
(QCI) Standards
3 Good Automated Laboratory Practices: Introduction to GALP, 12
Principles of GALP, GALP Requirements, SOPs of GALP, Training
Documentation, 21 CFR Part 11, General check list of 21CFR Part 11,
Software Evaluation checklist, relevant ISO and QCI Standards.

4 Good Distribution Practices: Introduction to GDP, Legal 12

GDPRequirements put worldwide, Principles, Personnel,
Documentation, Premises and Equipment, Deliveries to Customers,
Returns, Self-Inspection, Provision of information, Stability testing
principles, WHO GDP, USP GDP (Supply chain integrity), relevant
CDSCO guidance and ISO standards

5 Quality management systems: Concept of Quality, Total Quality 12

Management, Quality by design, Six Sigma concept, Out of
Specifications (OOS), Change control. Validation: Types of Validation,
Types of Qualification, Validation master plan (VMP), Analytical
Method Validation. Validation of utilities, [Compressed air, steam,
water systems, Heat Ventilation and Air conditioning (HVAC)]and
Cleaning Validation. The International Conference on Harmonization
(ICH) process, ICH guidelines to establish quality, safety and efficacy
of drug substances and products, ISO 13485, Sch MIII and other
relevant CDSCO regulatory guidance documents.

References
1. Good Laboratory Practice Regulations, by Sandy Weinberg, Fourth Edition
Drugs and the Pharmaceutical Sciences, Vol.168
2. Good Pharmaceutical Manufacturing practice, Rational and compliance by
John Sharp, CRC Press
3. Establishing a cGMP Laboratory Audit System, A practical Guide by David
M.Bleisner, Wiley Publication.
4. How to practice GLP by PP Sharma, Vandana Publications.
5. Laboratory Auditing for Quality and Regulatory compliance bu Donald
C.Singer, Drugs and the Pharmaceutical Sciences, Vol.150.
6. Drugs & Cosmetics Act, Rules & Amendments

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DOCUMENTATION AND REGULATORY WRITING (MRA 102T)

Scope
This course is designed to impart fundamental knowledge on documentation and
general principles involved in regulatory writing and submission to agencies.

Course Outcome
At the end of the course students will be able to…
CO1 Discuss the basic Documentation in pharmaceutical industry
CO2 Discuss on dossier preparation and CTD submission
CO3 Learn about eCTD and technologies available
CO4 Understand the basics of CTD submission in India through Sugam system
CO5 Learn the basics of internal and external audits
CO6 Learn ISO standards and guidelines on audits
CO7 Understand inspection systems in pharmaceutical companies and follow up
actions
CO8 Learn the regulatory aspects of product lifecycle management and product
recalls

Units Contents Hours

1 Documentation in pharmaceutical industry: Exploratory Product 12
Development Brief (EPDB) for Drug substance and Drug product,
Product Development Plan (PDP), Product Development Report
(PDR), Master Formula Record, Batch Manufacturing Record and its
calculations, Batch Reconciliation, Batch Packaging Records, Print
pack specifications, Distribution records, Certificate of Analysis
(CoA), Site Master File and Drug Master Files (DMF).
2 Dossier preparation and submission: Introduction and overview of 12
dossiers, contents and organization of dossier, binders and sections,
compilation and review of dossier. Paper submissions, overview and
modules of CTD, electronic CTD submissions; Electronic submission:
Planning electronic submission, requirements for submission,
regulatory bindings and requirements, Tool and Technologies,
electronic dossier submission process and validating the submission,
Electronic Submission Gateway (ESG). Non eCTD electronic
submissions (NeeS), Asian CTD formats (ACTD) submission.
Organizing, process and validation of submission.

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Submission in Sugam system of CDSCO.

3 Audits: Introduction, Definition, Summary, Types of audits, GMP 12
compliance audit, Audit policy, Internal and External Audits, Second
Party Audits, External third party audits, Auditing strategies,
Preparation and conducting audit, Auditing strategies, audit analysis,
audit report, audit follow up. Auditing/inspection of manufacturing
facilities by regulatory agencies. Timelines for audits/inspection.
GHTF study group 4 guidance document. ISO 13485.
4 Inspections: Pre-approval inspections, Inspection of pharmaceutical 12
manufacturers, Inspection of drug distribution channels, Quality
systems requirements for national good manufacturing practice
inspectorates, inspection report, model certificate of good
manufacturing practices, Root cause analysis, Corrective and
Preventive action (CAPA).
5 Product life cycle management: Prior Approval Supplement (PAS), 12
Post Approval Changes [SUPAC], Changes Being Effected in 30 Days
(CBE-30), Annual Report, Post marketing Reporting Requirements,
Post approval Labeling Changes, Lifecycle Management, FDA
Inspection and Enforcement, Establishment Inspection Report (EIR),
Warning Letters, Recalls, Seizure and Injunctions. ISO Risk
Management Standard

References
1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury
and Gil Bismuth, Interpharm/CRC, Boca Raton, London New York,
Washington D.C.
2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by
Shayne Cox Gad. Wiley-Interscience, A John Wiley and sons, Inc.,
Publications.
3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman
A. Hodges, Stephen P. Denyar. CRC Press. 2000.
4. Laboratory auditing for quality and regulatory compliance. Donald C.
Singer, Raluca- loana Stefan, Jacobus F. Van Staden. Taylor and Francis
(2005).
5. Implementing Juran's Road Map for Quality Leadership: Benchmarks and
Results, By Al Endres, Wiley, 2000
6. Understanding, Managing and Implementing Quality: Frameworks,
Techniques and Cases, By Jiju Antony; David Preece, Routledge, 2002

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7. Organizing for High Performance: Employee Involvement, TQM,

Reengineering, and Knowledge Management in the Fortune 1000: The CEO
Report By Edward E. Lawler; Susan Albers Mohrman; George Benson,
Jossey-Bass, 2001
8. Corporate Culture and the Quality Organization By James W. Fairfield-
Sonn, Quorum Books, 2001
9. The Quality Management Sourcebook: An International Guide to Materials
and Resources By Christine Avery; Diane Zabel, Routledge, 1997
10. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications.
11. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De
Feo, ASQ Publications
12. Root Cause Analysis, The Core of Problem Solving and Corrective Action,
Duke Okes, 2009, ASQ Publications
13. International Medical Device Regulators Forum (IMDRF) Medical Device
Single Audit Program (MDSAP)

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CLINICAL RESEARCH REGULATIONS (MRA 103T)

Scope
This course is designed to impart the fundamental knowledge on the clinical
development process of drugs, pharmaceuticals and Medical Devices, phases and
conduct of clinical trials and research, regulations and guidance governing the
conduct of clinical research in India, USA and EU. It prepares the students to learn
in detail on various laws, legislations and guidance related to safety, efficacy, ethical
conduct and regulatory approval of clinical research.

Course Outcome
At the end of the course students will be able to…
CO1 Understand the History, origin and ethics of clinical and biomedical
research and evaluation
CO2 Know Clinical drug, medical device development process, different types
and phases of clinical trials
CO3 Know the regulatory requirements and guidance for conduct of clinical trials
and research.
CO4 Understand the European union guidance for clinical evaluation and safety
for medicinal products and medical devices.
CO5 Understand the clinical, ethical principles, informed consent form, process
and documentation.
CO6 Know the General biostatic principles applied in clinical research.
CO7 Understand FDA guidance for bioavailability and bioequivalence
requirements for medicinal products
CO8 Understand Indian GCP, CDSCO and ICMR guidelines for biomedical
research.

Units Contents Hours

1 Clinical Drug Development Process 12
• Different types of Clinical Studies
• Phases of clinical trials, Clinical Trial protocol
• Phase 0 studies
• Phase I and subtype studies (single ascending, multiple ascending,
dose escalation, methods, food effect studies, drug – drug
interaction, PK end points
• Phase II studies (proof of concept or principle studies to establish

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efficacy)
• Phase III studies (Multi ethnicity, global clinical trial, registration
studies)
• Phase IV studies (Post Marketing Studies; PSUR)
Clinical Investigation and Evaluation of Medical Devices & IVDs
Different Types of Studies, Key Concepts of Medical Device Clinical
Evaluation, Key concepts of Clinical Investigation
2 Ethics in Clinical Research: 12
• Historical Perspectives: Nuremberg Code, Thalidomide study,
Nazis Trials, Tuskegee Syphilis Study, The Belmont Report,
The declaration of Helsinki
• Origin of International Conference on Harmonization - Good
Clinical Practice (ICH-GCP) guidelines.
• The ethics of randomized clinical trials
• The role of placebo in clinical trials
• Ethics of clinical research in special population
• Institutional Review Board/Independent Ethics Committee/ Ethics
Committee – composition, roles, responsibilities, review and
approval process and ongoing monitoring of safety data
• Data safety monitoring boards.
• Responsibilities of sponsor, CRO, and investigator in ethical
conduct of clinical research
• Ethical principles governing informed consent process
• Patient Information Sheet and Informed Consent Form
• The informed consent process and documentation
3 Regulations governing Clinical Trials 12
India: Clinical Research regulations in India – Schedule Y & Medical
Device Guidance
USA: Regulations to conduct drug studies in USA (FDA)
• NDA 505(b)(1) of the FD&C Act (Application for approval of a
new drug)
• NDA 505(b)(2) of the FD&C Act (Application for approval of a new
drug that relies, at least in part, on data not developed by the
applicant)
• ANDA 505(j) of the FD&C Act (Application for approval of a
generic drug product)
• FDA Guidance for Industry – Acceptance of Foreign Clinical

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Studies
• FDA Clinical Trails Guidance Document: Good Clinical Practice
EU: Clinical Research regulations in European Union (EMA)
4 Clinical Research Related Guidelines 12
• Good Clinical Practice Guidelines (ICH GCP E6)
• Indian GCP Guidelines
• ICMR Ethical Guidelines for Biomedical Research
• CDSCO guidelines
GHTF study group 5 guidance documents
Regulatory Guidance on Efficacy and Safety ICH Guidance’s
• E4 – Dose Response Information to support Drug Registration
• E7 – Studies in support of General Population: Geriatrics
• E8 – General Considerations of Clinical Trials
• E10 – Choice of Control Groups and Related Issues in Clinical
Trials,
• E 11 – Clinical Investigation of Medicinal Products in the Pediatric
Population
• General biostatics principle applied in clinical researc
5 USA & EU Guidance 12
USA: FDA Guidance
• CFR 21Part 50: Protection of Human Subjects
• CFR 21Part 54: Financial Disclosure by Clinical Investigators
• CFR 21Part 312: IND Application
• CFR 21Part 314: Application for FDA Approval to Market a New
Drug
• CFR 21Part 320: Bioavailability and bioequivalence
requirements
• CFR 21Part 812: Investigational Device Exemptions
• CFR 21Part 822: Post-market surveillance
• FDA Safety Reporting Requirements for INDs and BA/BE Studies
• FDA Med Watch
• Guidance for Industry: Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment
European Union: EMA Guidance
• EU Directives 2001
• EudraLex (EMEA) Volume 3 – Scientific guidelines for medicinal
products for human use
• EU Annual Safety Report (ASR)

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• Volume 9A – Pharmacovigilance for Medicinal Products for

Human Use
• EU MDD with respect to clinical research
• ISO 14155

References
1. Clinical Trials and Human Research: A Practical Guide to Regulatory
Compliance By Fay A. Rozovsky and Rodney K. Adams
2. HIPAA and Human Subjects Research: A Question and Answer Reference
Guide By Mark Barnes, JD, LLM and Jennifer Kulynych, JD, PhD
3. Principles and Practices of Clinical Research, Second Edition Edited by John
I. Gallin and Frederick P. Ognibene
4. Reviewing Clinical Trials: A Guide for the Ethics Committee; Johan PE
Karlberg and Marjorie A Speers; Karlberg, Johan Petter Einar, Hong Kong.
5. International Pharmaceutical Product Registration: Aspects of Quality,
Safety and Efficacy; Anthony C. Cartwright; Taylor & Francis Inc., USA.
6. New Drug Approval Process: The Global Challenge; Guarino, Richard A;
Marcel Dekker Inc., NY.
7. FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics; Douglas J. Pisano, David Mantus; CRC Press, USA
8. Country Specific Guidelines from official websites.
9. Drugs & Cosmetics Act & Rules and Amendments

Recommended websites:
1. EU Clinical Research Directive 2001: http://www.eortc.be/services/doc
/clinical- eudirective-04-april-01.pdf
2. Code of Federal Regulations, FDA: http://www.accessdata.fda.gov/scripts
/cdrh/cfdocs/cfcfr/cfrsearch.cfm
3. Guidelines of International Conference on Harmonization: http://www.
ich.org/products/guidelines.html
4. Eudralex Guidelines: http://www.gmpcompliance.info/euguide.html
5. FDA New Drug Application: http://www.fda.gov/regulatoryinformation
/legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterV
Drugs andDevices/ucm108 125.htm
6. Medicines and Healthcare products Regulatory Agency:
http://www.mhra.gov.uk

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7. Central Drugs Standard Control Organization Guidance for Industry:

http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf
8. ICMR Ethical Guidelines for Biomedical Research: http://icmr.nic.in
/ethical_guidelines.pdf

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DRUGS REGULATIONS AND OTHER LEGISLATION IN INDIA

AND INTELLECTUAL PROPERTY RIGHTS (MRA 104T)

Scope
This course is designed to impart fundamental knowledge on regulations and
legislation in India w.r.t. Drugs & Cosmetics, Medical Devices, Biologicals &
Herbals, and Food & Nutraceuticals. It prepares the students for basic regulatory
requirements in India of Drugs & Cosmetics, Medical Devices, Biologicals &
Herbals, and Food & Nutraceuticals. for manufacture, import & registration, export,
sale, marketing authorization, clinical trials and intellectual property rights.

Course Outcome
At the end of the course students will be able to…
CO1 Assess the approval process and regulatory requirements for drugs &
cosmetics, medical devices, biological & herbals, and food &
nutraceuticals
CO2 Examine the Indian Pharmacopoeial and BIS standards
CO3 Review and validate the guidelines for drug testing in animals
CO4 Practice the concept of Intellectual Property Rights
CO5 Describe the different acts and guidelines that regulate drugs & cosmetics,
medical devices, biological & herbals, and food & nutraceuticals industry
in India
CO6 Categorize the guidelines for drug testing in animals
CO7 Assess the regulatory requirements for bioequivalence study
CO8 Describe the role of IPR in regulatory affairs.

Units Contents Hours

1 Biologicals & Herbals, and Food & Nutraceuticals Acts and Rules 12
(with latest amendments):
1. Drugs and Cosmetics Act 1940 and Rules 1945: DPCO and NPPA
2. Other relevant provisions (rules schedules and guidelines for
approval of Drugs & Cosmetics, Medical Devices, Biologicals &
Herbals, and Food & Nutraceuticals in India
Other relevant Acts: Narcotics Drugs and Psychotropic Substances Act;
Medicinal and Toilet Preparations (Excise Duties) Act, 1955; Pharmacy
Act, 1948; Drugs and Magic Remedies (Objectionable
Advertisements) Act, 1955; Prevention of Cruelty to Animals Act.

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2 Regulatory requirements and approval procedures for Drugs & 12

Cosmetics Medical Devices, Biologicals & Herbals, and Food &
Nutraceuticals: CDSCO (Central Drug Standard Control Organization)
and State Licensing Authority: Organization, Responsibilities Rules,
regulations, guidelines and standards for regulatory filing of Drugs &
Cosmetics, Medical Devices, Biologicals & Herbals, and Food &
Nutraceuticals Format and contents of Regulatory dossier filing Clinical
trial/ investigations
3 Indian Pharmacopoeial Standards, BIS standards and ISO and other 12
relevant standards
4 Bioavailability and Bioequivalence data (BA &BE), BCS Classification 12
of Drugs, Regulatory Requirements for Bioequivalence study
Stability requirements: ICH and WHO
Guidelines for Drug testing in animals/Preclinical Studies Animal
testing: Rationale for conducting studies, CPCSEA Guidelines Ethical
guidelines for human participants ICMR-DBT Guidelines for Stem Cell
Research
5 Intellectual Property Rights: Patent, Trademark, Copyright, Industrial 12
Designs and Geographical Indications, Indian Patent Scenario. IPR vs
Regulatory Affairs

References
1. Manual of Patent Practice & Procedure, 3rd Edition, by The Patent Office
of India
2. Patent Failure How Judges, Bureaucrats, and Lawyers put innovators at risk
by James Bessen and Michael J. Meurer
3. Principles and Practice of Clinical Trial Medicine by Richard Chin and
Bruce Y. Lee
4. Ethical Guidelines for Biomedical Research on Human Participants by
Indian Council of Medical Research New delhi 2006.
5. CPCSEA Guidelines for Laboratory Animal Facility by Committee for the
purpose of control and supervision on experiments on animals (CPCSEA)
6. ICH E6 Guideline ― Good Clinical Practice‖ by ICH Harmonised Tripartite
7. Guidance for Industry on Submission of Clinical Trial Application for
Evaluating Safety and Efficacy by CDSCO (Central Drug Standard Control
Organisation)

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8. Guidance for Industry on Requirement of Chemical & Pharmaceutical

Information including Stability Study Data before approval of clinical trials
/ BE studies by CDSCO
9. Guidelines for Import and Manufacture of Medical Devices by CDSCO
10. Guidelines from official website of CDSCO

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REGULATORY AFFAIRS PRACTICAL - I (MRA 105P)

1. Case studies (4 Nos.) of each of Good Pharmaceutical Practices.

2. Documentation for in process and finished products Quality control tests for
Solid, liquid, Semisolid and Sterile preparations.
3. Preparation of SOPs, Analytical reports (Stability and validation)
4. Protocol preparation for documentation of various types of records (BMR,
MFR, DR)
5. Labeling comparison between brand & generics.
6. Preparation of clinical trial protocol for registering trial in India
7. Registration for conducting BA/ BE studies in India
8. Import of drugs for research and developmental activities
9. Preparation of regulatory dossier as per Indian CTD format and submission
in SUGAM
10. Registering for different Intellectual Property Rights in India
11. GMP Audit Requirements as per CDSCO
12. Preparation and documentation for Indian Patent application.
13. Preparation of checklist for registration of IND as per ICH CTD format.
14. Preparation of checklist for registration of NDA as per ICH CTD format.
15. Preparation of checklist for registration of ANDA as per ICH CTD format.
16. Case studies on response with scientific rationale to USFDA Warning Letter
17. Preparation of submission checklist of IMPD for EU submission.
18. Comparison study of marketing authorization procedures in EU.
19. Comparative study of DMF system in US, EU and Japan
20. Preparation of regulatory submission using eCTD software
21. Preparation of Clinical Trial Application (CTA) for US submission
22. Preparation of Clinical Trial Application (CTA) for EU submission
23. Comparison of Clinical Trial Application requirements of US, EU and Japan
of a dosage form.
24. Regulatory requirements checklist for conducting clinical trials in India.
25. Regulatory requirements checklist for conducting clinical trials in Europe.
26. Regulatory requirements checklist for conducting clinical trials in USA

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REGULATORY ASPECTS OF DRUGS & COSMETICS (MRA 201T)

Scope
This course is designed to impart the fundamental knowledge on the drug
development process, regulatory requirements for approval of new drugs, drug
products and cosmetics in regulated and semi-regulated countries. It prepares the
students to learn in detail on the regulatory requirements, documentation
requirements, and registration procedures for marketing the drug products and
cosmetics in regulated and semi-regulated countries.

Course Outcome
At the end of the course students will be able to…
CO1 Study the regulatory approval process and registration procedures for
API and drug products in USA and Canada
CO2 Explain the role of various committees across the globe ( APEC,
EAC, GCC, PANDRH, SADC)
CO3 Know the legislation and regulations for import, manufacture,
distribution and sale of drugs and cosmetics in EU and Australia
CO4 Understand the cosmetics regulations in regulated and semi-regulated
countries
CO5 Understand the legislation and regulations for manufacturing,
packaging and labelling of pharmaceuticals in Japan
CO6 Describe the requirements for registration of drugs and post
approval requirements in ASEAN countries
CO7 Study the regulatory prerequisites related to Marketing authorization
requirements for drugs and post approval requirements in CIS
countries
CO8 Understand the concept of Certificate of Pharmaceutical
Product(CoPP) in General and Country Specific

Units Contents Hours

1 USA & CANADA: Organization structure and functions of FDA. 12
Federal register and Code of Federal Regulations (CFR), History
and evolution of United States Federal, Food, Drug and Cosmetic
Act (FFDCA), Hatch Waxman act and Orange book, Purple book,
Drug Master Files (DMF) system in US, Regulatory Approval
Process for Investigational New Drug (IND), New Drug
Application (NDA), Abbreviated New Drug Application
(ANDA), Supplemental New Drug Application (SNDA);

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Regulatory requirements for Orphan drugs and Combination

Products, Changes to an approved NDA / ANDA. Regulatory
considerations for manufacturing, packaging and labeling of
pharmaceuticals in USA. Legislation and regulations for import,
manufacture, distribution and sale of cosmetics in USA and
Canada.
2 European Union & Australia: Organization and structure of 12
EMA & EDQM, General guidelines, Active Substance Master
Files (ASMF) system in EU, Content and approval process of
IMPD, Marketing Authorization procedures in EU (Centralized
procedure, Decentralized procedure, Mutual recognition
procedure and National Procedure). Regulatory considerations for
manufacturing, packaging and labeling of pharmaceuticals in EU,
Eudralex directives for human medicines, Variations &
extensions, Compliance of European Pharmacopoeia (CEP)/
Certificate of Suitability (CoS), Marketing Authorization (MA)
transfers, Qualified Person (QP) in EU. Legislation and
regulations for import, manufacture, distribution and sale of
cosmetics in European Union & Australia.
3 Japan: Organization of the PMDA, Pharmaceutical Laws and 12
regulations, types of registration applications, DMF system in
Japan, drug regulatory approval process, Regulatory
considerations for manufacturing, packaging and labeling of
pharmaceuticals in Japan, Post marketing surveillance in Japan.
Legislation and regulations for import, manufacture, distribution
and sale of cosmetics in Japan
4 Emerging Market: Introduction, Countries covered, Study of the 12
world map,study of various committees across the globe (ASEAN,
APEC, EAC, GCC, PANDRH, SADC)
WHO: WHO, GMP, Regulatory Requirements for registration of
drugs and post approval requirements in WHO through
prequalification programme, Certificate of Pharmaceutical
Product(CoPP) - General and Country Specific (South Africa,
Egypt, Algeria and Morocco, Nigeria, Kenya and Botswana)

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5 Brazil, ASEAN, CIS and GCC Countries: 12

ASIAN Countries: Introduction to ACTD, Regulatory
Requirements for registration of drugs and post approval
requirements in China and South Korea & Association of
Southeast Asian Nations (ASEAN) Region i.e. Vietnam,
Malaysia, Philippines, Singapore and Thailand.
CIS (Commonwealth Independent States): Regulatory pre-
requisites related to Marketing authorization requirements for
drugs and post approval requirements in CIS countries i.e. Russia,
Kazakhstan and Ukraine GCC (Gulf Cooperation Council) for
Arab states: Regulatory pre-requisites related to Marketing
authorization requirements for drugs and post approval
requirements in Saudi Arabia and UAE
Legislation and regulations for import, manufacture,
distribution and sale of cosmetics in Brazil, ASEAN, CIS and
GCC Countries.

References:
1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel
and Isader Kaufer, Marcel Dekker series, Vol.143
2. The Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel
Dekker Series, Vol.144
3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R.
Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences, Vol.185
Informa Health care Publishers.
4. New Drug Approval Process: Accelerating Global Registrations By Richard
A Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol.190.
5. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley
& Sons. Inc.
6. Drugs: From Discovery to Approval, Second Edition By Rick Ng
7. New Drug Development: A Regulatory Overview, Eighth Edition By Mark
Mathieu
8. Pharmaceutical Risk Management By Jeffrey E. Fetterman, Wayne L. Pines
and Gary H. Slatko
9. Preparation and Maintenance of the IND Application in eCTD Format By
William K. Sietsema
10. Country Specific Guidelines from official websites. http://www.who.int/
medicines/areas/quality_safety/regulation_legislation/ ListMRAWebsites.pdf

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11. Roadmap to an ASEAN economic community Edited by Denis Hew. ISEAS

Publications, Singapore 2005, ISBN981-230-347-2
12. ASEAN, Rodolfo C. Severino, ISEAS Publications, Singapore 2005, ISBN
978-981- 230-750-7
13. Building a Future with Brics: The Next Decade for Offshoring, Mark
Kobayashi-Hillary, Springer
14. Outsourcing to India: The Offshore Advantage, Mark Kobayashi-Hillary,
Springer Trade performance and Regional Integration of the CIS Countries,
Lev Freinkman,
15. The world Bank, Washington, DC, ISBN: 0-8212-5896-0
16. Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World By
Frederick M. Abbott, Graham Dukes, Maurice Nelson Graham Dukes 139
17. The Gulf Cooperation Council: A Rising Power and Lessons for ASEAN by
Linda Low and Lorraine Carlos Salazar (Nov 22, 2010)
18. Doing Business in the Asean Countries, Balbir Bhasin, Business Expert Press
ISBN:13:978-1-60649-108-9
19. Realizing the ASEAN Economic Community: A Comprehensive Assessment,
Michael G Plummer (Editor), Chia Siow Yue (Editor), Institute of South east
asian studies, Singapore

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REGULATORY ASPECTS OF HERBAL AND BIOLOGICALS

(MRA 202T)

Scope
This course is designed to impart fundamental knowledge on Regulatory
Requirements, Licensing and Registration, Regulation on Labelling of
Biologics in India, USA and Europe
It prepares the students to learn in detail on Regulatory Requirements for
biologics, Vaccines and Blood Products

Course Outcome
At the end of course students will be able to…
CO1 Recognize the regulation for newly developed biologics and biosimilars.
CO2 Explain the pre-clinical and clinical development considerations of biologics.
CO3 Discuss the regulatory requirements of blood and/or its components including
blood products and label requirements.
CO4 Set up the quality and safety of herbal products.
CO5 Describe the regulatory requirements for biologics and vaccines.
CO6 Describe the regulatory requirements for the herbal products.
CO7 Set up the quality and safety of herbal products.
CO8 Set up the legislation for herbal products.

Units Contents Hours

1 India : Introduction, Applicable Regulations and Guidelines , 12
Principles for Development of Similar Biologics, Data Requirements
for Preclinical Studies, Data Requirements for Clinical Trial
Application, Data Requirements for Market Authorization
Application, Post-Market Data for Similar Biologics,
Pharmacovigilance. GMP and GDP.
2 USA: Introduction to Biologics; biologics, biological and biosimilars, 12
different biological products, difference between generic drug and
biosimilars, laws, regulations and guidance on biologics/ biosimilars,
development and approval of biologics and biosimilars (IND, PMA,
BLA, NDA, 510(k), pre-clinical and clinical development
considerations, advertising, labelling and packing of biologics

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3 European Union: Introduction to Biologics; directives, scientific 12

guidelines and guidance related to biologics in EU,
comparability/biosimilarity assessment, Plasma master file, TSE/ BSE
evaluation, development and regulatory approval of biologics
(Investigational medicinal products and biosimilars), pre-clinical and
clinical development considerations; stability, safety, advertising,
labelling and packing of biologics in EU
4 Vaccine regulations in India, US and European Union: Clinical 12
evaluation, Marketing authorisation, Registration or licensing, Quality
assessment, Pharmacovigilance, Additional requirements Blood and
Blood Products Regulations in India, US and European Union:
Regulatory Requirements of Blood and/or Its Components Including
Blood Products, Label Requirements, ISBT (International Society of
Blood Transfusion) and IHN (International Haemovigilence Network)

5 Herbal Products: Quality, safety and legislation for herbal products 12

in India, USA and European Union.

References
1. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices,
and Biologics, Douglas J. Pisano , David S. Mantus ; Informa ,2008
2. Biological Drug Products: Development and Strategies; Wei Wang ,
Manmohan Singh ; wiley ,2013
3. Development of Vaccines: From Discovery to Clinical Testing; Manmohan
Singh , Indresh K. Srivastava ;Wiley, 2011
4. www.who.int/biologicals/en
5. www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInfo
rmation/
6. www.ihn-org.com
7. www.isbtweb.org
8. Guidelines on Similar Biologics: Regulatory Requirements for Marketing
Authorization in India
9. www.cdsco.nic.in
10. www.ema.europa.eu › scientific guidelines › Biologicals
11. www.fda.gov/biologics bloodVaccines/Guidance Compliance Regulatory
Information (Biologics)

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REGULATORY ASPECTS OF MEDICAL DEVICES (MRA 203T)

Scope
This course is designed to impart the fundamental knowledge on the medical devices
and in vitro diagnostics, basis of classification and product life cycle of medical
devices, regulatory requirements for approval of medical devices in regulated
countries like US, EU and Asian countries along with WHO regulations. It prepares
the students to learn in detail on the harmonization initiatives, quality and ethical
considerations, regulatory and documentation requirements for marketing medical
devices and IVDs in regulated countries.

Course Outcome
At the end of the course students will be able to…
CO1 Know the basics of medical devices and IVDs, process of development,
ethical and quality considerations.
CO2 Know the quality system regulations and quality risk management of
medical devices.
CO3 Know the medical devices and IVDs directives in European Union and
USA.
CO4 Understand organizational structure, regulatory guidelines and functions
of IMDRF/GHTF.
CO5 Know Harmonization initiatives for approval and marketing of medical
devices and IVDs.
CO6 Understand regulatory approval process for medical devices and IVDs in
India, US, and Europe.
CO7 Know clinical evaluation and investigation of medical devices and IVDs.
CO8 Understand regulatory approval process for medical devices and IVDs in
China, Japan and ASEAN countries.

Units Contents Hours

1 Medical Devices: Introduction, Definition, Risk based 12
classification and Essential Principles of Medical Devices and IVDs.
Differentiating medical devices IVDs and Combination Products
from that of pharmaceuticals, History of Medical Device
Regulation, Product Lifecycle of Medical Devices and
Classification of Medical Devices.

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IMDRF/GHTF: Introduction, Organizational Structure, Purpose

and Functions, Regulatory Guidelines, Working Groups, Summary
Technical Document (STED), Global Medical DeviceNomenclature
(GMDN).
2 Ethics: Clinical Investigation of Medical Devices, Clinical 12
Investigation Plan for Medical Devices, Good Clinical Practice for
Clinical Investigation of medical devices (ISO 14155:2011)
Quality: Quality System Regulations of Medical Devices: ISO
13485, Quality Risk Management of Medical Devices: ISO 14971,
Validation and Verification of Medical device, Adverse Event
Reporting of Medical device
3 USA: Introduction, Classification, Regulatory approval process for 12
Medical Devices (510k) Premarket Notification, Pre-Market
Approval (PMA), Investigational Device Exemption (IDE) and In
vitro Diagnostics, Quality System Requirements 21 CFR Part 820,
Labeling requirements 21 CFR Part 801, Post marketing
surveillance of MD and Unique Device Identification (UDI).
Basics of In vitro diagnostics, classification and approval process.
4 European Union: Introduction, Classification, Regulatory approval 12
process for Medical Devices (Medical Device Directive, Active
Implantable Medical Device Directive) and In vitro Diagnostics (In
Vitro Diagnostics Directive), CE certification process. Basics of In
vitro diagnostics, classification and approval process.
5 ASEAN, China & Japan: Medical Devices and IVDs, Regulatory 12
registration procedures, Quality System requirements and clinical
evaluation and investigation. IMDRF study groups and guidance
documents.

References
1. FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics by Douglas J. Pisano, David Mantus.
2. Medical Device Development: A Regulatory Overview by Jonathan S. Kahan
3. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical
Devices by John J. Tobin and Gary Walsh
4. Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics
by Carmen Medina
5. Country Specific Guidelines from official websites.

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REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS

(MRA 204T)

Scope
This course is designed to impart the fundamental knowledge on Regulatory
Requirements, Registration and Labeling Regulations of Nutraceuticals in India,
USA and Europe.
It prepares the students to learn in detail on Regulatory Aspects for nutraceuticals
and food supplements.

Course Outcome
At the end of the course students will be able to…
CO1 Define and differentiate nutraceuticals, functional foods, dietary
supplements, and medical foods
CO2 Discuss the scope and opportunities in nutraceutical market
CO3 Learn the history of nuraceuticals and their regulations
CO4 Learn the global aspects of regulations in food and nutraceutical markets
CO5 Understand the nutraceutical regulations in India
CO6 Learn the nutraceutical regulations in USA
CO7 Study the nutraceutical regulations in European Union
CO8 Understand and compare the Recommended Dietary Allowance in various
regulated countries

Units Contents Hours

1 Nutraceuticals: Introduction, History of Food and Nutraceutical 12
Regulations, Meaning of Nutraceuticals, Dietary Supplements,
Functional Foods, Medical Foods, Scope and Opportunities in
Nutraceutical Market.
2 Global Aspects: WHO guidelines on nutrition. NSF International: Its 12
Role in the Dietary Supplements and Nutraceuticals Industries, NSF
Certification, NSF Standards for Food And Dietary Supplements.
Good Manufacturing Practices for Nutraceuticals.
3 India: Food Safety and Standards Act, Food Safety and Standards 12
Authority of India: Organization and Functions, Regulations for
import, manufacture and sale of nutraceutical products in India,
Recommended Dietary Allowances (RDA) in India.

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4 USA: US FDA Food Safety Modernization Act, Dietary Supplement 12

Health and Education Act. U.S. regulations for manufacture and sale
of nutraceuticals and dietary supplements, Labelling Requirements
and Label Claims for Dietary Supplements, Recommended Dietary
Allowances (RDA) in the U.S
5 European Union: European Food Safety Authority (EFSA):
Organization and Functions. EU Directives and regulations for
manufacture and sale of nutraceuticals and dietary supplements.
Nutrition labelling. European Regulation on Novel Foods and Novel
Food Ingredients. Recommended Dietary Allowances (RDA) in
Europe.

References
1. Regulation of Functional Foods and Nutraceuticals: A Global Perspective by
Clare M. Hasler (Wiley Online Library)
2. Nutraceutical and Functional Food Regulations in the United States and
Around the World by Debasis Bagchi (Academic Press, Elsevier)
3. http://www.who.int/publications/guidelines/nutrition/en/
4. http://www.europarl.europa.eu/RegData/etudes/STUD/2015/536324/IPOL_S
TU(2015)5 36324_EN.pdf
5. Handbook of Nutraceuticals by Yashwant Pathak (CRC Press)
6. Food Regulation: Law, Science, Policy and Practice by Neal D. Fortin (Wiley)
7. Country Specific Guidelines from official websites.

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REGULATORY AFFAIRS PRACTICAL - II (MRA 205P)

1. Case studies
2. Change Management/ Change control. Deviations
3. Corrective & Preventive Actions (CAPA)
4. Documentation of raw materials analysis as per official monographs
5. Preparation of audit checklist for various agencies
6. Preparation of submission to FDA using eCTD software
7. Preparation of submission to EMA using eCTD software
8. Preparation of submission to MHRA using eCTD software
9. Preparation of Biologics License Applications (BLA)
10. Preparation of documents required for Vaccine Product Approval
11. Comparison of clinical trial application requirements of US, EU and India
of Biologics
12. Preparation of Checklist for Registration of Blood and Blood Products
13. Registration requirement comparison study in 5 emerging markets (WHO)
and preparing check list for market authorization
14. Registration requirement comparison study in emerging markets (BRICS)
and preparing check list for market authorization
15. Registration requirement comparison study in emerging markets (China
and South Korea) and preparing check list for market authorization
16. Registration requirement comparison study in emerging markets
(ASEAN) and preparing check list for market authorization
17. Registration requirement comparison study in emerging markets (GCC)
and preparing check list for market authorization
18. Checklists for 510k and PMA for US market
19. Checklist for CE marking for various classes of devices for EU
20. STED Application for Class III Devices
21. Audit Checklist for Medical Device Facility
22. Clinical Investigation Plan for Medical Devices

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