M.Pharm Regulatory Affairs Syllabus
Regulatory Affairs is the M.Pharm specialisation on drug regulations, dossiers and approvals in India and across the world. This page gives the complete syllabus of the branch as prescribed by the Pharmacy Council of India, subject by subject and unit by unit. This branch has no Modern Pharmaceutical Analytical Techniques subject; its Semester 1 is made of four branch subjects.
Source: Pharmacy Council of India (PCI), The Revised Regulations for the Master of Pharmacy Degree Program, Credit Based Semester System, and the M.Pharm syllabus prescribed by the Pharmacy Council of India. The syllabus below is reproduced from the PCI syllabus, unit by unit.
Semester 1
MRA101T Good Regulatory Practices
Subject notes: MRA101T Good Regulatory Practices notes
Unit 1: Current Good Manufacturing Practices
Introduction, US cGMP 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.
Unit 2: Good Laboratory Practices
Introduction, USFDA GLP Regulations (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.
Unit 3: Good Automated Laboratory Practices
Introduction to GALP, Principles of GALP, GALP Requirements, SOPs of GALP, Training Documentation, 21 CFR Part 11, General checklist of 21CFR Part 11, Software Evaluation checklist, relevant ISO and QCI Standards.
Unit 4: Good Distribution Practices
Introduction to GDP, Legal GDP requirements 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.
Unit 5: Quality Management Systems
Concept of Quality, Total Quality 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 M III, and other relevant CDSCO regulatory guidance documents.
MRA102T Documentation and Regulatory Writing
Subject notes: MRA102T Documentation and Regulatory Writing notes
Unit 1: Documentation in Pharmaceutical Industry
Exploratory Product 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).
Unit 2: Dossier Preparation and Submission
Introduction and overview of 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, tools and technologies, electronic dossier submission process and validating the submission, Electronic Submission Gateway (ESG). Non eCTD electronic submissions (NeeS), Asian CTD (ACTD) submission. Organizing, process and validation of submission. Submission in the SUGAM system of CDSCO.
Unit 3: Audits
Introduction, definition, summary, types of audits, GMP compliance audit, audit policy, internal and external audits, second party audits, external third party audits, auditing strategies, preparation and conducting of audits, audit analysis, audit report, audit follow up. Auditing and inspection of manufacturing facilities by regulatory agencies. Timelines for audits and inspections. GHTF study group 4 guidance document. ISO 13485.
Unit 4: Inspections
Pre-approval inspections, inspection of pharmaceutical 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).
Unit 5: Product Life Cycle Management
Prior Approval Supplement (PAS), 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.
MRA103T Clinical Research Regulations
Subject notes: MRA103T Clinical Research Regulations notes
Unit 1: Clinical Drug Development Process
Types of clinical studies; phases of clinical trials; clinical trial protocol; Phase 0 studies; Phase I and subtype studies (single ascending dose, multiple ascending dose, dose escalation methods, food effect studies, drug-drug interaction, PK end points); Phase II studies (proof of concept); Phase III studies (multi ethnicity, global clinical trials, registration studies); Phase IV studies (post marketing studies, PSUR); clinical investigation and evaluation of medical devices and IVDs; key concepts of medical device clinical evaluation and of clinical investigation.
Unit 2: Ethics in Clinical Research
Historical perspectives: Nuremberg Code, thalidomide study, Nazi trials, Tuskegee syphilis study, the Belmont Report, the Declaration of Helsinki; origin of ICH Good Clinical Practice (ICH-GCP) guidelines; ethics of randomized clinical trials; the role of placebo; ethics of clinical research in special populations; Institutional Review Board, Independent Ethics Committee, Ethics Committee: composition, roles, responsibilities, review and approval process, ongoing monitoring of safety data; data safety monitoring boards; responsibilities of sponsor, CRO and investigator; ethical principles governing the informed consent process; Patient Information Sheet and Informed Consent Form; the informed consent process and documentation.
Unit 3: Regulations Governing Clinical Trials
India: Schedule Y and Medical Device guidance, NDCT Rules 2019 (clinical trials, bioavailability and bioequivalence studies of new drugs and investigational new drugs, general principles and practices, conduct of clinical trials, post market assessment) and Medical Devices Rules 2017. USA: FDA, NDA 505(b)(1), NDA 505(b)(2) and ANDA 505(j) of the FD&C Act, FDA guidance on acceptance of foreign clinical studies, FDA clinical trials guidance on Good Clinical Practice. EU: clinical research regulations of the European Union (EMA).
Unit 4: Clinical Research Related Guidelines
Indian GCP guidelines; ICMR ethical guidelines for biomedical research; CDSCO guidelines; GHTF study group 5 guidance documents; ICH efficacy and safety guidances E4 (dose response), E7 (geriatrics), E8 (general considerations for clinical trials), E10 (choice of control group), E11 (pediatric population); general biostatistics principles applied in clinical research. The PTU copy additionally prints ICH GCP E6 (Good Clinical Practice Guidelines, ICH GCP E6) as the first item of this unit; the GPRCP copy covers the origin of ICH-GCP in Unit 2. Both content sets are taught.
Unit 5: USA and EU Guidance
USA: 21 CFR Part 50 (protection of human subjects), Part 54 (financial disclosure), Part 312 (IND), Part 314 (marketing approval applications), Part 320 (bioavailability and bioequivalence), Part 812 (investigational device exemptions), Part 822 (postmarket surveillance); FDA safety reporting requirements for INDs and BA/BE studies; MedWatch; guidance on good pharmacovigilance practices and pharmacoepidemiologic assessment. EU: EU directives 2001, EudraLex Volume 3 (scientific guidelines) and Volume 9A (pharmacovigilance), EU Annual Safety Report, EU Medical Device Regulation with respect to clinical research, ISO 14155.
MRA104T Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals in India and Intellectual Property Rights
Unit 1: Acts and Rules
Acts and Rules (with latest amendments): (a) Drugs and Cosmetics Act 1940 and Rules 1945; DPCO and NPPA. (b) Other relevant provisions (rules, schedules and guidelines for approval of Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals in India). Other relevant Acts: Narcotic Drugs and Psychotropic Substances Act; Medicinal and Toilet Preparations (Excise Duties) Act, 1955; Pharmacy Act, 1948; Drugs and Magic Remedies (Objectionable Advertisements) Act; Prevention of Cruelty to Animals Act.
Unit 2: Regulatory Requirements and Approval Procedures
Regulatory requirements and approval procedures for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals. CDSCO (Central Drugs 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 and investigations.
Unit 3: Standards
Indian Pharmacopoeial standards, BIS standards and ISO and other relevant standards.
Unit 4: Bioavailability, Bioequivalence and the Ethics Framework
Bioavailability and bioequivalence data (BA & BE); BCS classification of drugs; regulatory requirements for bioequivalence study; stability requirements: ICH and WHO guidelines for drug testing in animals and preclinical studies; guidelines for animal testing; animal testing: rationale for conducting studies, CPCSEA guidelines; ethical guidelines for human participants; ICMR-DBT guidelines for stem cell research.
Unit 5: Intellectual Property Rights
Patent, trademark, copyright, industrial designs and geographical indications; Indian patent scenario; IPR versus Regulatory Affairs.
Practicals and Seminar
- MRA105P Regulatory Affairs Practical I
- Seminar/Assignment
Semester 2
MRA201T Regulatory Aspects of Drugs & Cosmetics
Subject notes: MRA201T Regulatory Aspects of Drugs & Cosmetics notes
Unit 1: USA and Canada
Historical perspectives; organization structure and functions of FDA; Federal Register and Code of Federal Regulations (CFR); history and evolution of the 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) and Supplemental NDA (sNDA); 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.
Unit 2: European Union and Australia
Organization and structure of EMA and 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 and extensions; Certificate of Suitability (CEP/CoS) of the European Pharmacopoeia; marketing authorization (MA) transfers; Qualified Person (QP) in EU; legislation and regulations for import, manufacture, distribution and sale of cosmetics in European Union and Australia.
Unit 3: Japan
Organization of the PMDA; pharmaceutical laws and 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. (The unit carries no separate cosmetics item, unlike Units 1, 2 and 5.)
Unit 4: Emerging Markets and WHO
Introduction and countries covered; study of the world map; study of various committees across the globe (ASEAN, APEC, EAC, GCC, PANDRH, SADC); WHO GMP; regulatory requirements for registration of drugs and post approval requirements through the WHO prequalification programme; Certificate of Pharmaceutical Product (CoPP), general and country specific (South Africa, Egypt, Algeria and Morocco, Nigeria, Kenya and Botswana); Brazil, ASEAN, CIS and GCC countries.
Unit 5: Asian Countries, CIS and GCC
Introduction to ACTD (Asian Common Technical Document); regulatory requirements for registration of drugs and post approval requirements in China and South Korea and the ASEAN region (Vietnam, Malaysia, Philippines, Singapore and Thailand); CIS (Commonwealth of Independent States) marketing authorization and post approval requirements (Russia, Kazakhstan and Ukraine); GCC regulatory pre-requisites for marketing authorization and post approval requirements (Saudi Arabia and UAE); legislation and regulations for import, manufacture, distribution and sale of cosmetics in Brazil, ASEAN, CIS and GCC countries.
MRA202T Regulatory Aspects of Herbal & Biologicals
Subject notes: MRA202T Regulatory Aspects of Herbal & Biologicals notes
Unit 1: India
Introduction; applicable regulations and guidelines; 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.
Unit 2: USA
Introduction to biologics; biologics, biologicals and biosimilars; different biological products; difference between a generic drug and biosimilars; laws, regulations and guidance on biologics and 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.
Unit 3: European Union
Introduction to biologics; directives, scientific guidelines and guidance related to biologics in EU; comparability and 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 and clinical evaluation; advertising, labelling and packing of biologics in EU.
Unit 4: Vaccines and Blood Products
Vaccine regulations in India, US and European Union: clinical evaluation, marketing authorisation, registration or licensing, quality assessment, pharmacovigilance, additional requirements. Blood and blood products regulations in India, US and European Union: regulatory requirements for blood and/or its components including requirements for blood products; label requirements; ISBT (International Society of Blood Transfusion) labelling and the IHN (International Haemovigilance Network).
Unit 5: Herbal Products
Quality, safety and legislation for herbal products in India, USA and European Union.
MRA203T Regulatory Aspects of Medical Devices
Subject notes: MRA203T Regulatory Aspects of Medical Devices notes
Unit 1: Medical Devices, Introduction
Introduction; definition; risk based classification and essential principles of medical devices and IVDs; differentiating medical devices, IVDs and combination products from pharmaceuticals; history of medical device regulation; product lifecycle of medical devices; classification of medical devices. IMDRF/GHTF: introduction, organizational structure, purpose and functions, regulatory guidelines, working groups, Summary Technical Documentation (STED), Global Medical Device Nomenclature (GMDN).
Unit 2: Ethics and Quality
Clinical investigation of medical devices; clinical investigation plan; Good Clinical Practice for clinical investigation of medical devices (ISO 14155). Quality system regulations for medical devices: ISO 13485. Risk management of medical devices: ISO 14971. Validation and verification of medical devices. Adverse event reporting of medical devices.
Unit 3: USA
Introduction; classification; regulatory approval process for medical devices: Premarket Notification 510(k), Premarket 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 medical devices and Unique Device Identification (UDI). Basics of in vitro diagnostics, classification and approval process.
Unit 4: European Union
Introduction; classification; regulatory approval 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.
Unit 5: ASEAN, China and Japan
Medical devices and IVDs: regulatory registration procedures, quality system requirements and clinical evaluation and investigation of medical devices and IVDs. IMDRF study groups and guidance documents (see point 2 below).
MRA204T Regulatory Aspects of Food & Nutraceuticals
Subject notes: MRA204T Regulatory Aspects of Food & Nutraceuticals notes
Unit 1: Nutraceuticals, Introduction
Introduction; history of food and nutraceutical regulations; meaning of nutraceuticals, dietary supplements, functional foods and medical foods; scope and opportunities in the nutraceutical market.
Unit 2: International and Global Aspects
WHO guidelines on nutrition; NSF International and its role in the dietary supplements and nutraceuticals industries; NSF certification; NSF standards for food and dietary supplements; Good Manufacturing Practices for nutraceuticals.
Unit 3: India
Food Safety and Standards Act; Food Safety and Standards Authority of India (FSSAI): organization and functions; regulations for import, manufacture and sale of nutraceutical products in India; Recommended Dietary Allowances (RDA) in India.
Unit 4: USA
US FDA Food Safety Modernization Act (FSMA); Dietary Supplement Health and Education Act (DSHEA); US regulations for manufacture and sale of nutraceuticals and dietary supplements; labelling requirements and label claims for dietary supplements; Recommended Dietary Allowances (RDA) in the US.
Unit 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; regulation of functional foods.
Practicals and Seminar
- MRA205P Regulatory Affairs Practical II
- Seminar/Assignment
Semester 3 and 4
Semester 3 and Semester 4 are common to all M.Pharm specialisations. They cover Research Methodology and Biostatistics (MRM301T), journal club, discussion and presentation, and research work. The full common structure is given on the M.Pharm Common Semester 3 and 4 Syllabus page.