REGULATORY AFFAIRS - GENERAL KNOWLEDGE
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
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
3) In RA, we are using system ___________ for variation/document submission to NPRA.
NPRA
Quest3+
MDA
Quest
List 3 license often applied by RA.
List 3 certificates often applied by RA.
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
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