REGULATORY AFFAIRS - GENERAL KNOWLEDGE

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Regulatory Affairs Quiz

Test your knowledge in Regulatory Affairs with our comprehensive quiz designed for professionals and enthusiasts alike. This quiz covers key concepts, guidelines, and processes within the field.

Multiple choice questions
Real-world applications
Interactive formats

15 Questions4 MinutesCreated by AnalyzingData417

What are generic products?

Product that is essentially similar to a currently registered product in Malaysia

Product that have not been previously registered

Products used to supplement a diet

What are guidelines that can be used as a reference (You may select more than one)

EMA

WHO

DRGD

NPRA

3) In RA, we are using system ___________ for variation/document submission to NPRA.

NPRA

Quest3+

MDA

Quest

ASEAN Common Technical Dossier consists of these

Part I - IV

Module 1 - 5

Part I & Part II

Submission of the renewal must be within _________ of the product expiry

1 year

3 months

6 months

What are the Post-Registration Activities (You may select more than one)

Renewal

Post Market Surveillance

Amendment (Variation)

Withdrawal

What are 2 exporting countries by Pharmaniaga

Singapore, Hong Kong

Brunei, Macau

United States of America, Australia

Japan, South Korea

What are the benefits of eCTD (You may select more than one)

Save cost

Reduce approval time

Less requirement

Longer validity of the product

Select 2 Regulatory Agency in ASEAN

BPOM

Department of Pharmaceutical Services

Gulf Health Council

Please arrange the registration flow for export country

Country, Agent and Product selection by IS department

Dossier review and compilation by RA department

Dossier review by Agent

Dossier evaluation by Health Authority

Product Registration Approval

REGULATORY AFFAIRS - GENERAL KNOWLEDGE

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