Case Study Assignment
1. Name the modules for the below sections mentioned
CTD Header Module
Excipient Specifications 3.2.P.4.1
Labelling Information 1.3.11
Information on Quality and Non-Quality Module3,4,5
Experts
Pharmacological Tests 4.2.1
Container Closure System 3.2.P.7, 3.2.S.6
Appendices 3.2.A
Nomenclature 3.2.S.1.1
Description and Composition of Drug 3.2.P.1
Product
Stability Data 3.2.S.7 , 3.2.P.8
Application Form 1.3
Cover Letter 1.1
Quality Overall Summary 2.3
2. Mention the products which are listed under mandatory scope for CP in
Europe
Ans- Medicinal products for human use: New active substance, Biotechnology
derived medicines , Advanced therapy medicinal products, orphan medicines
Medical product for veterinary use
Combination products
3.Timeline of CTD evaluation
Ans : . Preparation for CTD 3 to 12 months
.Submission of CTD -1 DAY
.Validation check -1to 3 months
.Evaluation phase -6 to 12 months
.Decision phase- 1 to 3 months
.Post approval Activities– on going
the entire process approx 12 to 24 months
4.Name the Reg Authority of the countries given below and their dossier
submission format
a. New Zealand- Medsafe -Medicines And Medical Devices Safety Authority
b. Switzerland- Swissmedic- Swiss Agency for Therapeutic Products
c. South Africa -South African Health Product Regualatory Authority
(SAPHRA)
d. Russia - Federal Service for Suvelliance in Health care
e. Canada- Health Canada
f. Brazil-ANVISA -Agencia National de Vigilancia Sanitaria
g. Singapore - Health Sciences Authority ( HSA)
h. Spain-The Spanish Agency of Medicines andMedicines and Medical
Devices(AEMPS)
i. China-China Food and Drug Administration, National Medical Products
Administration (NMPA )
j. Saudi Arabia-SFDA -Saudi Food and Drug Authority
5.Name the different pathways to register a drug in Europe
● centralized procedue
● Decentralized procedure
● Mutual recognition procedure
● National procedure
● conditional marketing authorization
● accelerated assessment
6. Give an example of different types of Variations in EMA – Type IA, Type IA
IN and Type II
ans : Type IA Variations-eg. deleting details of where the product i s packaged
Type IA IN variations eg. changing in imprints ,bossing or other markings
Type II variations eg. change in oral weight of oral doasge forms
7.What are the drug registration timelines for a new product in the given below
countries
ANS :India-8 to 15 years
USA -10 to 15 years
Japan- 10 to 15 years
Mexico - 8 to 15 years
United Kingdom -8 to 15 years
Austria -8 to 15 years
Malaysia -8 to 15 years
Vietnam 8 to 15 years
Kazakhstan -8 to 15 years
8.Which countries follow the annual report method submission and write a short
note on Annual Report
Ans European Union (EMA)
Canada (Health Canada)
Australia (Therapeutic Goods Administration, TGA)
Japan (PMDA)
Brazil (ANVISA)
India (CDSCO)
China (NMPA)
United States (FDA)
An annual report is a comprehensive document submitted by pharmaceutical and
medical device manufacturers to regulatory agencies that provides key information on
the safety, efficacy, and performance of a product after it has been approved and is
available on the market. It is a critical part of post-market surveillance, helping to
ensure that products continue to meet safety standards and are properly managed
throughout their lifecycle.
9.Write a short note on CEP – example – Types, Payment, Inspections and
Submission procedure
Ans Certificate of Suitability to the Monographs of the European
Pharmacopoeia (CEP)
The Certificate of Suitability (CEP) is a document issued by the European Directorate
for the Quality of Medicines & HealthCare (EDQM), certifying that a substance used in
pharmaceutical manufacturing complies with the quality standards defined in the European
Pharmacopoeia (Ph. Eur.) monographs. It is widely used to demonstrate the quality of raw
materials (active pharmaceutical ingredients or excipients) in the manufacturing of drugs,
ensuring that they meet stringent safety and quality requirements.
TYPES OF CEP FEES
certificate for chemical purity and 5000 euros
microbiological quality( chemical CEP)
certificate for herbal drugs and herbal drug 3000 euros
properties (herbal CEP)
TSE certificate 3000 euros
certificate for chemical purity or 8000 euros
microbiological quality and sterility
double certificate( chemical + TSE) 8000 euros
double certificate( chemical + TSE) also 9000 euros
chemical sterility
Inspections:
● Manufacturing Site Inspections: Before issuing a CEP, the EDQM may inspect the
manufacturing facilities where the API or excipient is produced. The inspection
ensures that the manufacturing process complies with the monograph requirements
and Good Manufacturing Practice (GMP).
● Regular inspections are also performed to ensure ongoing compliance.
Submission Procedure:
1. Application: The applicant must submit a complete dossier, including detailed
information on the production process, quality control, testing, and compliance with
Ph. Eur. monographs.
2. Evaluation: The EDQM evaluates the application, which may include an inspection
of the manufacturing site and analysis of the data provided.
3. Issuance: Once approved, the EDQM issues the CEP, which is valid for five years
and can be renewed.
10.Enlist the different types of DMF and enlist the different types of submission
done to USFDA with regards to DMF
Ans : types of DMF : Type I: Manufacturing site
Type II : drug substance ,drug substance intermediate
Type III : Packaging material
Type IV : Excipient, colorant
Type V : FDA accepted reference information
Different types of submissions done to USFDA:* Initial DMF submission
*DMF amendment
*DMF annual report
* DMF notification
* DMF instatement
* DMF closure
11.Write a note on emergency approval of medical products by regulatory
agencies?
Ans Emergency approval of medical products by regulatory agencies, such as the
FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or
WHO (World Health Organization), is a process designed to expedite access to
essential treatments during public health crises. This approval is typically granted for
new drugs, vaccines, or medical devices that demonstrate promising safety and
efficacy in early-phase clinical trials or preliminary data, particularly in situations like
pandemics, natural disasters, or bioterrorism events.
12.Name the functions involved in ANDA filing?
Ans :1 . preclinical research
2. formulation development
3. stability testing
4. bioequilance studies
5. regulatory affairs
6. quality assurance
7. manufacturing
8. labelling and packaging
9. clinical trails
