Overview of drug regulation and approval

https://www.fda.gov/drugs/information-consumers-and-patients-drugs/overview-our-role-
regulating-and-approving-drugs-video-series

US drug approval
https://credevo.com/articles/2020/04/30/drug-regulatory-approval-in-the-united-states-
part-i-2/

UNIT V
The role, need & scope of Regulatory Affairs in Pharmaceutical industry
Terminologies : IND, NDA, ANDA, sNDA, BLA, RLD, CFR,ICF,EDQM,CDSCO,
EDQM - https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-
coalitions-initiatives/european-directorate-quality-medicines-healthcare-edqm-council-
europe#:~:text=European%20Directorate%20for%20the%20Quality,of%20Europe%20%7C
%20European%20Medicines%20Agency

Laws & Act : Hatch & Waxman Act

Law & Act : EU Medical Device Regulation (1 hour)
https://www.slideshare.net/zaxotes/regulatory-approval-process-for-medical-devices-in-eu
https://www.medical-device-regulation.eu/mdr-guidance-documents/
https://www.fticonsulting.com/emea/insights/articles/medical-devices-regulation-mdr
https://youtu.be/O9nV7rJMicQ (EU)
https://youtu.be/RN9-IqZAqyM (US)

Basics of medicine regulation in EU

Basics of medicines regulation - EUPATI Toolbox
Marketing authorisation | European Medicines Agency (europa.eu)

Canada
Drug Process Infographic - 11x8.5 - EN.pdf (dystoniacanada.org)
Canadian-Drug-Review-Approval-and-Reimbursement-Process.pdf (jointhealth.org)
Pharmaceutical Drugs Directorate - Canada.ca
Drug products - Canada.ca
How Drugs are Reviewed in Canada - Canada.ca
Guidance for completing the Drug Submission Application Form - Canada.ca
Guidance Document: The Management of Drug Submissions and Applications - Canada.ca

GMP guidelines (1hour)

https://www.researchgate.net/publication/320373559_Good_manufacturing_Practice

Code of Federal regulation (include references & 21CFR)

Include Orange book & Purple book

RLD &RS in orange book

https://www.pharmaspecialists.com/2021/10/difference-between-rld-vs-rs.html?m=1#gsc.tab=0
https://www.pharmaspecialists.com/2021/12/referencing-approved-drug-products-in-anda.html?
m=1#gsc.tab=0
 1. https://www.investopedia.com/terms/o/orange-book.asp (orange book)
2. Orange Book Preface | FDA
3. Therapeutic equivalence codes- The Orange Book Codes Summary. | PDF (scribd.com)
4. FDA’s orange book and ab ratings of pharmaceutical drug products: a guide to community
pharmacist - MedCrave online
5. From Our Perspective: The Orange Book at 40: A valued FDA resource continually
enhanced by user input | FDA
6. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-
licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or
(purple book)
The Purple Book (fda.gov)
View of The Purple Book: Evaluations, Approvals and recent updates (ijdra.com)

7. https://guides.library.txstate.edu/c.php?g=553975&p=3806417 (CFR and FR)

8. https://libguides.law.umich.edu/c.php?g=1005584&p=7284939 (CFR and FR)
9. https://www.slideshare.net/ArabindaChangmai/code-of-federal-regulations-cfr-in-
pharmaceutical-88513524
10. https://www.ecfr.gov/current/title-21
11.

ICF-

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials

https://www.umc.edu/Research/Research-Offices/Clinical-Trials/Researchers/Road-Map/Study-
Assessment/Design-ICF.html

https://www.who.int/groups/research-ethics-review-committee/guidelines-on-submitting-research-
proposals-for-ethics-review/templates-for-informed-consent-forms

New drug and clinical trial rules INDIA

https://www.insightsonindia.com/2023/06/30/new-drugs-and-clinical-trial-rules-2023/#:~:text=Context
%3A%20The%20government%20of%20India,and%20effectiveness%20of%20new%20drugs.

https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/New-Drugs/

Research Ethics Review Committee (ERC)

 Assignments

1. https://forms.gle/w6xmJ7mXpQ26fkdS8
2.

Blue Print Pharmaceutical Regulatory Sciences

Question pattern MCQ (20 questions) Descriptive Descriptive (Any seven out
(Any two out of three) of nine)
Marks (Total 75) 20 20 35
Unit 1 (10 hrs) 5 questions 1 question 2 questions
Unit 2 (12 hrs) 2.1 (3 questions) 1 question 2.1 (1 question)
2.2 (2 questions) 2.2 (1 question)
Unit 3 (10 hrs) 5 questions 1 question 2 questions
Unit 4 (8 hrs) 3 questions - 2 questions
Unit 5 (5 hrs) 2 questions - 1 question