WorksheetsBasics of drug regulation
Total questions: 20
Worksheet time: 10mins
The Common Technical Document (CTD) was developed under the initiative of:
WHO
ICH
FDA
EMA
Which CTD module is region-specific and not harmonized?
Module 1
Module 2
Module 3
Module 5
The eCTD primarily differs from CTD because it:
Contains additional modules
Is submitted only in PDF format
Is an electronic, XML-based submission
Is applicable only in the US
Which module of CTD contains the Quality (CMC) information?
Module 2
Module 3
Module 4
Module 5
A New Drug Application (NDA) in the US is submitted under which section of the FD&C Act?
Section 351
Section 505(b)(1)
Section 505(j)
Section 701
An Abbreviated New Drug Application (ANDA) is primarily intended for:
New chemical entities
Biosimilars
Generic drugs
Vaccines
Bioequivalence data in ANDA submission is compared with:
Investigational drug
Reference Listed Drug (RLD)
Placebo
Active Pharmaceutical Ingredient
A Biologics License Application (BLA) in the US is regulated under:
FD&C Act
Drug Price Competition Act
Public Health Service Act
Hatch–Waxman Act
In India, similar biologics are regulated jointly by CDSCO and:
ICMR
DBT
NIPER
AIIMS
The Indian guidelines for Similar Biologics were first issued in:
2008
2009
2012
2018
Which authority is responsible for drug regulation in the JAPAN?
EMA
PMDA
TGA
CDSCO
The regulatory authority of China is:
NMPA
MHLW
JPMA
MHW
Drug regulation in Australia is overseen by:
MHW
NMPA
FDA
TGA
The European Medicines Agency (EMA) evaluates medicines for:
Individual EU countries only
WHO member countries
Non-EU European countries
European Union member states
Centralized marketing authorization in the EU results in approval that is valid in:
One country
Five countries
Selected countries
All EU member states
The Central Drugs Standard Control Organisation (CDSCO) in India functions under:
Ministry of Health & Family Welfare
Ministry of Chemicals & Fertilizers
NITI Aayog
ICMR
Which submission format is mandatory for most regulatory agencies today for lifecycle management?
Paper CTD
NeeS
eCTD
ACTD
What is the primary purpose of a New Drug Application (NDA)?
To report adverse effects
To apply for a patent
To submit post-marketing data
To request approval for a new drug
The International Conference on Harmonisation (ICH) aims to:
Standardize drug pricing
Harmonize regulatory requirements
Develop new drug formulations
Monitor drug safety post-approval
The World Health Organization (WHO) provides guidelines for:
National drug policies
Global health standards
Drug pricing
Pharmaceutical marketing
