Questions and Answers for Regulatory Affairs

What do you mean by ‘DMF’?

Drug Master File: a confidential submission to a regulatory authority containing detailed information on facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drug substances, drug products, or components. It allows the DMF holder to provide confidential CMC information to regulators while permitting applicants to reference the DMF in their applications.

State Hatch-Waxman Act.

The Drug Price Competition and Patent Term Restoration Act (1984) — establishes the ANDA pathway for generics (bioequivalence vs full NDA), provides 180-day exclusivity incentives for first generic challengers, and allows patent term restoration for certain patented drugs to compensate regulatory delay.

Regulatory requirements for product approval of MHRA countries.

(MHRA = UK regulator) Requires a comprehensive dossier (usually CTD/eCTD) including CMC, non-clinical, clinical data, risk/benefit, GMP compliance, QP certification, labeling, and post-approval pharmacovigilance plans. For variations, follow UK-specific guidance and any post-Brexit divergence from EMA.

Define ‘CTD’ and ‘eCTD format’

CTD = Common Technical Document: harmonized dossier structure with Modules 1–5 (regional info, quality, nonclinical, clinical). eCTD = electronic CTD: standardized XML backbone and folder structure for electronic regulatory submissions.

Mention the role of IMPD in non-clinical drug development

IMPD (Investigational Medicinal Product Dossier) documents the quality, manufacture, and non-clinical (toxicology, pharmacology) data supporting safe human use in clinical trials (used in EU/ROW submissions to support CTA).

What do you mean by the global submission of an ANDA?

Coordinated strategy to file generic product applications in multiple countries — adapting technical dossier and regulatory requirements (bioequivalence, labeling, CMC) to each jurisdiction while leveraging shared data packages.

Functions of the Institutional Review Board (IRB)

Protect human subjects by reviewing/approving research protocols, informed consent documents, monitoring safety, ensuring ethical conduct, assessing risk/benefit, and overseeing continuing review and adherence to regulations.

Steps for developing clinical trial protocols

Define objectives/endpoints → design (population, randomization, blinding, sample size/statistics) → inclusion/exclusion criteria → study procedures and schedule → safety monitoring/AE reporting → informed consent form → data management/CRFs → regulatory/ethics approvals → operational considerations (sites, CRO, monitoring).

Explain the term ‘CFR’

Code of Federal Regulations — the codified rules published by U.S. federal agencies. For drugs, Title 21 CFR contains FDA regulations (e.g., parts on GMP, IND, NDA, bioequivalence).

What do you mean by post-approval regulatory affairs?

Activities after marketing approval: labeling changes, manufacturing/site changes (post-approval variations), pharmacovigilance, annual reports, renewals, inspections, compliance, and lifecycle management.

What do you mean by CMC?

Chemistry, Manufacturing, and Controls — a section of regulatory dossiers describing drug substance/product manufacturing, specifications, analytical methods, stability, and quality assurance.

Discuss in brief about Post Marketing Surveillance

Ongoing monitoring of safety/effectiveness after approval: spontaneous AE reporting, signal detection, risk management plans, pharmacoepidemiology studies, periodic safety update reports (PSURs/PBRERs), and regulatory actions as needed.

Importance of Regulatory Affairs

Ensures compliance with laws/guidelines, enables timely approvals, manages risk, communicates with regulators, supports lifecycle strategy, protects patient safety, and facilitates market access.

What do you mean by Distribution records?

Documentation of product distribution history (batch numbers, quantities, shipping dates/recipients) used to support traceability, recall actions, and regulatory inspections.

Describe outsourcing BA and BE to CRO

Outsourcing bioanalytical (BA) and bioequivalence (BE) studies to CROs involves contracting specialized labs/organisations to design/execute PK studies, sample analysis, data management, and report generation — with oversight via contracts, quality agreements, audit, and data integrity controls.

Phases of clinical trials

Phase I: safety/tolerability, PK (small, healthy volunteers); Phase II: dose-finding, preliminary efficacy (patients); Phase III: confirmatory efficacy and safety (large populations); Phase IV: post-marketing studies and surveillance.

Brief note on Hatch-Waxman Act and amendments

Hatch-Waxman created generic approval pathways and patent litigation mechanisms (Paragraph IV) and patent restoration. Amendments and related legislation shaped exclusivity rules and patent linkage practices; exact procedural details evolve, so consult current FDA guidance.

What do you mean by ICH?

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use — develops harmonized guidelines (Q, S, M, E, etc.) to streamline global regulatory requirements for quality, safety, efficacy, and multidisciplinary topics.

What is Ca ontract Research Organization?

CRO: company providing outsourced clinical, preclinical, regulatory, or laboratory services to sponsors (study management, monitoring, statistics, data management, etc.).

Describe Pharmacovigilance

Science and activities relating to detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems throughout a product’s lifecycle.

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What are controlled documents?

Documents under formal change control (SOPs, batch records, specs, validation docs) are maintained with version control, approval signatures, distribution lists, and periodic review to ensure integrity and compliance.

Role of SOP in the pharmaceutical industry

Standard Operating Procedures ensure consistent performance of routine tasks, regulatory compliance, quality assurance, training baseline, audit readiness, and reduction of variability and risk.

Classify different types of documents

Examples: controlled (SOPs, specifications), operational (work instructions, batch records), regulatory (CTD, licenses), quality (deviation reports, CAPA), clinical (protocols, CRFs), and administrative (contracts, training records).

Summarize the role of the institutional review board.

IRB/IEC protects participant rights/welfare, reviews ethical and regulatory compliance of clinical research, approves consent, monitors safety, and enforces continuing oversight.

Explain the importance of the Code of Federal Regulations

CFR translates statutes into enforceable regulatory requirements; compliance is mandatory for market access in the U.S.; it defines standards for GMP, clinical conduct, and reporting.

Summarize different phases of clinical trials

I: safety/PK; 

II: efficacy/dose; 

III: confirmatory large trials; 

IV: post-marketing surveillance and additional studies.

Explain combination products

Products combining drug, device, and/or biological components (e.g., drug-eluting stent, prefilled syringe). Regulatory pathway depends on primary mode of action; coordinated review by relevant centers (e.g., FDA’s CDER/CDRH).

Compare typical differences between IND and NDA

IND (Investigational New Drug) application: request to begin human clinical trials; contains preclinical data, protocol, CMC. NDA (New Drug Application): request for marketing approval; contains full clinical efficacy/safety data, CMC, labeling, and risk management.

What is ANDA?

Abbreviated New Drug Application: regulatory submission for a generic drug demonstrating bioequivalence to a reference listed drug; does not require full clinical efficacy data.

Explain the role of ICH in the quality of the finished product

ICH Q-guidelines (e.g., Q1–Q12) provide principles for stability, impurities, GMP, quality risk management, and lifecycle approaches to ensure consistent quality of finished products globally.

Regulatory requirements for product approval of API and biologics

API: detailed CMC (synthesis, controls, impurities, specifications, stability), GMP certification, reference standards, and analytical methods. Biologics: in addition to CMC, require demonstration of characterisation (identity, purity, potency), control of cell banks, validated biological assays, comparability data, cold-chain and handling, and often more extensive non-clinical/clinical data due to complexity.

Regulation for combination products and medical devices

Combination products are regulated based on the primary mode of action; sponsors must follow device and/or drug guidance, submit appropriate dossiers (e.g., 510(k), PMA for devices, NDA/BLA for drug components), and meet both GMP and device quality system (QSR) requirements. Labeling, human factors, and compatibility testing are critical.

Explain the ANDA regulatory approval process

Prepare ANDA with CMC data, bioequivalence study reports, labeling, patent certifications (Paragraphs I–IV), and facility information; submit to FDA (eCTD); FDA conducts review (including inspections), addresses deficiencies (CRLs), and upon approval issues an ANDA allowing generic marketing. Patent litigation (Paragraph IV) can delay approval.

Describe HIPAA as a new requirement to the clinical study process

HIPAA (US) governs the privacy/security of protected health information (PHI). In clinical studies, HIPAA requires patient authorization for PHI use/disclosure, use of limited data sets or de-identification when possible, secure handling/storage of PHI, business associate agreements with vendors, and training and safeguards for compliance.

Write a detailed note on the Global submission of Investigational New Drug.

Global IND strategy requires harmonizing data packages (CTD Modules 2–5), aligning non-clinical packages (IMPD for EU), preparing local regulatory forms/requirements, addressing country-specific safety reporting and import/export rules, coordinating multi-region safety monitoring, and planning for staggered submissions based on regional readiness and clinical site selection.

Discuss the scale-up process approval changes

Scale-up/tech transfer requires demonstrating process understanding and control (QbD principles), revalidation of critical steps, comparability studies, stability bridging, and submission of variations or supplements (e.g., CBE/major sNDA) per regulatory guidance. Risk assessment and robust change control with regulatory filings are needed.

Major components of the Master formula record

Product identification, batch size/yield calculations, ingredient list with specifications and quantities, step-wise manufacturing instructions, in-process controls, equipment, environmental conditions, sampling/testing instructions, packaging/labeling instructions, and QC release criteria.

Explain the ANDA for generic drug approval in Uthe S

ANDA demonstrates pharmaceutical equivalence and bioequivalence, includes CMC, manufacturing, labeling, patent certifications, and is reviewed by the FDA for safety, efficacy, equivalence, and facility compliance.

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Describe the submission of DMF (Drug Master File)

DMF submission includes detailed CMC information for a component (API, excipient, packaging, manufacturing facility). It is submitted to the regulatory authority and can be referenced by applicants via letters of authorization. DMFs are reviewed to support multiple applications while protecting proprietary data; DMF types and procedures vary by region (e.g., Type II for API in US).

Short notes on ‘master formula record’ and ‘Code of Federal Regulation’.

• Master formula record: authoritative manufacturing recipe
• CFR: authoritative source of U.S. federal regulations; Title 21 governs FDA requirements, including GMP, IND/NDA procedures, and clinical trial conduct.

Ways and means of US registration for foreign drugs

Appoint U.S. agent, prepare appropriate dossier (ANDA/NDA/BLA) in eCTD, ensure facilities meet FDA inspection requirements (GMP), provide labeling and safety data, and comply with import/export and customs rules; use local regulatory consultants as needed.

Short notes on ‘CTD’ and ‘eCTD format’

CTD: harmonized dossier structure. eCTD: XML backbone enabling electronic lifecycle management, publishing, and standardized submissions.

Brief note on ‘non-clinical drug development’

Involves pharmacology (PD), toxicology (acute, subchronic, genotoxicity, safety pharmacology), ADME studies, and proof-of-concept animal models to characterize safety profile and dose rationale before human trials.

Formulation and working procedure of the Independent Ethics Committee

IEC charter, membership with diverse expertise, SOPs for review, quorum rules, conflict-of-interest management, meeting scheduling, recordkeeping, expedited review procedures, continuing review and monitoring, and decision notification processes.

Brief note on ‘informed consent process and procedures’

Provide understandable info on study purpose, procedures, risks/benefits, alternatives, confidentiality, compensation, and withdrawal rights; obtain voluntary signature; document consent; use translations as needed; allow time for questions and comprehension checks.

Short note on ‘industry and FDA liaison’

Interaction channels: pre-IND/meeting requests, Type A/B/C meetings, correspondence, guidance documents, and advisory committees. Effective liaison builds alignment on development plans and regulatory expectations.

Short notes on ‘drug master file and master formula record’

DMF: confidential supplier/manufacturer dossier. Master formula record: internal production recipe and control document for each marketed batch.

Describe the ICH guidelines of ICH-Q and ICH-S

ICH-Q (Quality): guidelines on stability (Q1), impurities (Q3), GMP/QMS (Q10), QbD (Q8–Q11) for consistent product quality.

ICH-S (Safety): nonclinical safety testing (S1–S7), including genotoxicity, carcinogenicity, reproductive toxicology, and safety pharmacology.

Regulatory requirements for the conduct of clinical trials

Ethical approval (IRB/IEC), informed consent, trial registration (e.g., clinicaltrials.gov), adherence to GCP, IND/CTA filing, qualified investigators, monitoring and safety reporting, data integrity, and record retention.

Brief note on ‘Global submission of NDA’

NDA (or regional equivalents) global strategy requires harmonized CTD dossiers, alignment of clinical endpoints with regional expectations, local regulatory forms, translation of documents, and management of region-specific post-approval commitments.

Formulation and working procedure of the Institutional Review Board

charter, SOPs, membership diversity, protocol review process, informed consent oversight, continuing review and reporting, recordkeeping.

Purpose and content of Investigator brochure

Investigator’s Brochure (IB) summarizes clinical and nonclinical data relevant to the study of an investigational product: preclinical data, clinical trial experience, safety profile, dosing rationale, risks, and investigator responsibilities — used to inform investigators and IRBs.

Regulatory requirements of ROW countries for product approval

ROW (Rest of World) varies: many adopt CTD structure, require local stability data, GMP certification, dossier translation, local agent, and country-specific labeling. Always check national agency guidance for exact requirements.

How would you apply the significance of Hatch-Waxman act and amendments?

Use Hatch-Waxman provisions to plan generic development (ANDA), manage patent challenges (Paragraph IV), pursue exclusivity strategies, and estimate market entry timelines; ensure patent and exclusivity assessments are part of the regulatory strategy.

Outline Investigator brochure

Title page, table of contents, summary, introduction, physical/chemical properties, nonclinical studies, clinical trial data, pharmacology/PK, safety info, dosing, administration, contraindications, and references.

Illustrate the regulation for medical devices

Device regulation depends on class/risk: classification, conformity assessment (ISO 13485, QMS), performance and biocompatibility testing, clinical evaluation, premarket submission (510(k)/PMA/CE marking), post-market surveillance and vigilance reporting.

Analyze the Global submission of IND

Harmonize preclinical and CMC data, prepare regional regulatory dossiers (IMPD for EU), address differences in safety reporting, and plan phased submissions aligned with global clinical site activation.

Illustrate the role of HIPAA

HIPAA protects PHI privacy and security: applies safeguards, authorizations, the minimum necessary principle, breach notification, and business associate obligations — impacting data handling in clinical research.

Illustrate the Industry and FDA liaison

Effective liaison uses formal meeting requests, pre-submission meetings, sponsor-initiated communications, and adherence to FDA guidance to obtain feedback, clarify expectations, and de-risk development plans.

Assess Pharmacovigilance safety monitoring in clinical trials

PV in trials includes real-time AE/SAE reporting, DSMBs for high-risk studies, expedited reporting to regulators/IRBs, periodic safety summaries, signal detection, data safety monitoring plans, and integration with post-marketing PV systems.

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