BP707TSemester 72 creditsTheoryKEY SUBJECT

Regulatory Affairs

Complete unit-wise syllabus for BP707T as per the PCI B.Pharm NEP 2020 curriculum (Semester 7 — Pharmacovigilance + Regulatory + Research).

URL:https://pharmacode.in/syllabus/semester-7/bp707t-regulatory-affairs/

Unit-wise Syllabus

5 Units

Introduction to Drug Regulatory Agencies6 Hours

Drug regulatory agencies: CDSCO (India), USFDA (USA), EMA (Europe), TGA (Australia), Health Canada, PMDA (Japan), WHO prequalification programme
Basic regulatory terminologies: guidance documents, guidelines, regulations, laws, acts; drug development regulatory milestones
Regulatory reference resources: Orange Book (USFDA), Purple Book (biosimilars), EMA product databases; ICH guideline categories (Q, S, E, M guidelines)

Indian Regulatory Framework and Approval Process6 Hours

CDSCO structure: Central Drug Standard Control Organization; Drug Controller General of India (DCGI); State Drug Authorities; zonal offices
New drug approval in India: New Drugs and Clinical Trials Rules 2019; IND application (CTA in India); Phase I-III waiver conditions; fast-track designation; accelerated approval
Generic drug approval: ANDA equivalent in India; bioequivalence requirements; biowaiver criteria (BCS-based); post-marketing surveillance obligations

CDSCO and International Regulatory Submissions6 Hours

Central Drugs Standard Control Organization (CDSCO): licensing authority roles; schedule of drugs requiring central licence (Schedule C, C1, X drugs); import registration
USFDA NDA/ANDA process: 505(b)(1) full NDA, 505(b)(2) NDA (literature-based), 505(j) ANDA; user fees (PDUFA); priority review, breakthrough therapy, fast track, orphan drug designations
EMA centralised, decentralised, mutual recognition, and national procedures; Marketing Authorisation Application (MAA) structure; CHMP review process

Common Technical Document (CTD) Format6 Hours

CTD structure: Module 1 (regional administrative); Module 2 (summaries — QOS, NCA, NES, CNS); Module 3 (quality); Module 4 (non-clinical study reports); Module 5 (clinical study reports)
eCTD (electronic CTD): specification, backbone, submission sequence; eCTD viewer tools; regional variations in CTD requirements
Module 3 quality documentation: drug substance (S sections), drug product (P sections), appendices; QbD elements in Module 3; CTD formatting requirements

Clinical Trials Regulation and Good Regulatory Practice6 Hours

Clinical trial regulations in India: Schedule Y; CTRI (Clinical Trial Registry India) mandatory registration; Ethics Committee accreditation; subject protection; safety reporting timelines (SUSAR, SAE)
Post-marketing surveillance: Phase IV studies; post-authorisation safety and efficacy studies (PASS, PAES); risk management plans; variation management (major, minor, type I, type II); label updates
Good Regulatory Practice (GRP): WHO-CDSCO-THSTI certification; GRP principles; regulatory filing quality; regulatory intelligence; interaction with regulatory agencies; regulatory strategy

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