RA GENERAL KNOWLEDGE (LOCAL REGISTRATION)

What is NPRA? And NPRA stands for?
What are guidelines that can be used as a reference (You may select more than one)
EMA
WHO
DRGD
NPRA
How many product classification are stated in the DRGD? Can you name it one by one?
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 at least 3 manufacturing sites in Pharmaniaga
List 3 certificates often applied by RA.
ASEAN Common Technical Dossier consists of these
Part I - IV
Module 1 - 5
Part I & Part II
Part II of the ACTD dossier consist of (You may select more than one)
Administrative Data
Product information
Drug Product
Drug Substance
Submission of the renewal must be within _________ of the product expiry
1 year
3 months
6 months
Please rearrange the registration process below:
Screening
Dossier Acceptance
Technical Assessment
Assessment Complete
DCA Meeting
Final Decision
What are the Post-Registration Activities (You may select more than one)
Renewal
Post Market Surveillance
Amendment (Variation)
Withdrawal
If there are changes proposed by the manufacturing site on the registered product, what should RA do?
Should the registered product is no longer active in the market, how can we withdraw the registration of the product?
Let the registration lapse
Submit official letter to NPRA
Recall all products in the market
Submit amendment to NPRA
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