Top Regulatory Affairs Questions & Answers | Clinoxy

Regulatory Affairs Course | Regulatory Affairs Training | Top Regulatory Affairs Institute in Hyderabad – Clinoxy

Regulatory Affairs (RA) ensures that pharmaceutical products are developed, manufactured, and marketed according to government regulations and industry standards.

It ensures patient safety, product efficacy, and compliance with legal requirements before drugs reach the market.

Preparing and submitting regulatory documents, maintaining product licenses, ensuring compliance, and communicating with health authorities.

They are official documents submitted to authorities like the FDA, EMA, or CDSCO to gain approval for clinical trials or marketing.

1. Pre-clinical approval
2. Clinical trial authorization
3. Marketing authorization
4. Post-marketing surveillance

A dossier is a collection of all required data and documents submitted for regulatory approval.

The Common Technical Document (CTD) is a standardized format for submitting data to regulatory agencies.

There are five modules: administrative, summaries, quality, non-clinical, and clinical.

CTD is paper-based, while eCTD is the electronic version used for digital submissions.

FDA (USA), EMA (Europe), CDSCO (India), MHRA (UK), PMDA (Japan).

An Investigational New Drug application seeks permission to start clinical trials in humans.

A New Drug Application requests marketing approval for a new drug in the U.S.

An Abbreviated New Drug Application is used to get approval for generic drugs.

A Drug Master File provides confidential information about the manufacturing, quality, and control of a drug substance.

It’s an update to an existing marketing authorization, such as a label change or formulation update.

Labeling provides product details, dosage, warnings, and helps ensure safe drug use.

Pre-approval occurs before marketing authorization; post-approval relates to maintaining and updating an approved product.

GRP are guidelines ensuring that regulations and decisions are transparent, consistent, and science-based.

It involves monitoring the safety of approved drugs and reporting adverse reactions to authorities.

Form 44 (new drugs), Form 45 (clinical trials), and Form 46 (import/manufacture permissions).

ICH harmonizes technical guidelines to ensure safety, quality, and efficacy across regions.

GMP (Good Manufacturing Practice) ensures quality in production; GLP (Good Laboratory Practice) ensures reliability in lab testing.

Medicines developed for rare diseases affecting a small population.

Biological products similar in safety and efficacy to an approved reference product

A plan that defines how to gain and maintain approvals efficiently across global markets.

Monitoring drug safety and performance after market approval.

They include renewals, labeling updates, and new indications after drug approval.

A regulatory pathway allowing faster approval for drugs addressing serious conditions.

Aligning regulations and documentation across regions for global consistency.

Attention to detail, understanding of guidelines, communication skills, and knowledge of drug development.