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CTD, NeeS & eCTD
Compilation
& submission
of the dossiers
Dr. Asmaa Khalil, M.Sc.
RA Manager – CTD , NeeS & eCTD Instructor
 Regulatory Affairs Manager.
 B.S. in Pharmaceutical Sciences from Cairo University.
 M.Sc. in Biochemistry.
 19 Years experience in the pharmaceutical field.
 Expert in CTD, NeeS & eCTD compilation & submission of dossiers.
 Speaker of more than 64 workshops in Egypt & GCC for RA,
CTD/eCTD sessions and pharmaceutical field.
Asmaa Khalil El-Kersh
• All medicines must grant a Marketing Authorization (MA) in order to be placed
on the market legally in the country.
• The ultimate purpose of marketing authorization is to ensure that safe, effective
& high-quality medicines, as to protect public health.
Medicines
Manufacturing site departments
Warehouse
Production & Engineering QA QC PV
Medical Affairs Artwork/Labelling
RA Marketing
Story of Diseases
& Medicines
Story of Diseases & Medicines
Step 1: Discovery & Development
Step 2: Preclinical Research
Step 3: Clinical Research
Step 5: Post-marketing-Safety Monitoring
Step 4: Government review
Step 1: Discovery & Development
Researchers try to identify
the disease
Research for a new drug begins in the
laboratory through designing a product to stop
or reverse the effects of the disease
Innovator
product
Step 2: Preclinical Research
Before testing a drug in people, researchers must find out whether it has the potential to cause serious
harm (toxicity).
Drugs undergo laboratory & animal testing to answer basic questions about safety.
These studies must provide detailed information on dosing & toxicity levels.
After preclinical testing, researchers review their findings & decide whether the drug should be tested in
people.
Innovator
product
Step 3: Clinical Research
Step 4: Post-marketing-Safety Monitoring
• Purpose: safety &
dosage
• Study Participants:
20 to 100 healthy
volunteers or people
with the
disease/condition.
• Length of Study:
several months
• Approximately 70%
of drugs move to the
next phase
Drugs are tested on people to make sure they are safe & effective.
• Purpose: efficacy &
side effects
• Study Participants:
several hundred
patients
• Length of Study:
several months to
two years
• Approximately 33%
of drugs move to the
next phase
• Trials test for
effectiveness &
monitoring of
adverse reactions
• Study Participants:
300 to 3,000 patients
• Length of Study: 1
to 4 years
• Approximately 25-
30% of drugs move
to the next phase
• Trials test for safety
& efficacy
• Study Participants:
Several thousand
volunteers who
have the
disease/condition
• Post Marketing
Surveillance Trials:
after a drug or
device has been
approved for
consumer sale.
Innovator
& Generic
product
Research for a new drug begins
in the laboratory.
Drugs undergo laboratory
& animal testing to answer basic
questions about safety.
Drugs are tested on people to make sure they
are safe, effective, monitoring of ADRs, the
effectiveness of dose
FDA review teams thoroughly examine all of the
submitted data related to the drug or device & make a
decision to approve or not to approve it.
FDA monitors all drug & device safety once
products are available for use by the public
22-Feb-24
Company
Product
Regulatory
Affairs
(RA)
Regulatory
Authorities
22-Feb-24
RA is responsible to revise, compile & submit
the registration file of drug product
and manufacturing site “if required”
to Health authority (HA),
as to grant the MA / GMP.
Companies Global HA
Link
R
A
Link
RA
22-Feb-24
Responsibility of RA
Regulatory Affairs
RA is a profession developed:
by the companies responsible for the discovery,
testing, manufacture & marketing of these products
wanting to ensure that they supply products that are
safe & make a worthwhile contribution to public
health.
from the desire of governments to protect public
health by controlling the safety & efficacy of products
in areas including pharmaceuticals, veterinary
medicines, medical devices, pesticides & cosmetics.
What is the strategy of RA?
Plan for:
• Registration of product in the global market (to be in line with
corporate, business and strategy of RA unit & projects).
• Developing the product with the goal of obtaining regulatory
approval in desired markets “new molecular entities (chemical &
biopharmaceutical), drug rediscovery”.
• Lifecycle management/maintenance post approval
“maintenance of existing products, new indications, new API
(Active Pharmaceutical Ingredient) suppliers, new markets, line
extensions, variations & site transfers”.
• Balance time & cost & human resources.
Regulatory
Affairs
• Business development
• Marketing & Sales
•Medical / Clinical
• R&D
• QA / QC / Compliance
•Pharmacovigilance
• Manufacturing sites
• Supply Chain “SC”
• Labeling
• Finance Legal
• Logistics
• HR
• Customer service
International
Regulatory
Agencies
Regulatory
Health
Authorities
22-Feb-24
Interactions with RA
Regulatory Affairs
The Link Between
Pharma Companies & Governmental Authorities
Support & follow up with HAs, as to submit all dossiers
of:
• MAH &/or manufacturing sites registration;
• Product's registration / renewal/ variation / price ;
• Replying & responding to all received inquiries from
HAs;
• Provides support to tender & importation requests.
until receiving registration license /approval.
Prepare /compile/ revise / submit
Registration doc. to regulatory authorities
Optimizing & speeding “time to market”
strategic thinking & definitions of
regulatory strategies
Give strategic & technical advice to R&D, QC,
QA, Production , SC & Medical Affairs
Keep track on every update in
international authorities guidelines
Participating in:
• Manufacturing site & portfolio optimization activities.
• Merger, Demerger & Divestment activities.
What is the role of
Regulatory Affairs ?
Perform integral roles throughout
healthcare product lifecycle at every stage
of development, distribution, marketing &
post market surveillance of drugs, medical
devices, biotechnology products & other
vital medical treatments.
Identification of various regulatory
options for drug development.
Distribution of approval documents /
certificates & regulatory documents archiving.
Regulatory Pathway
Evaluation/
Inspection/
Testing
HAs regulations mainly cover the mentioned below activities:
• Pre-marketing evaluation of the quality, safety and efficacy of a medicine, including
compliance of manufacturing sites & processes with GMP standards.
• Assessment & inspection of all components of the SC “manufacturing sites/laboratories/CDMO”.
• Maintenance of a registered products and post-marketing surveillance activities, including
random sampling of registered medicines for QC & PV.
• Promotion, advertising & marketing of medicines information.
• Price control
Submission /
Publishing
Business
validation
Technical
validation
Pricing Licensing
Post-
marketing
Model isn’t unified, it may be changed depending on each HA process.
22-Feb-24
Product Type
Innovator
=Originator
= Brand
Generic Hybrid
• Pre-clinical & Clinical
study
• Non-Clinical study
• BA study
The above mentioned
studies are requested for
innovator product.
A Reference Listed Drug
(RLD) is an approved drug
product to which new
generic versions are
compared to show that they
are bioequivalent.
Medication created to be the
same as an existing approved
brand-name drug in dosage
form, safety, strength, route of
administration, quality &
performance characteristics.
BE studies vs. approved
Reference
Listed Drug (RLD):
• Once BE is conducted,
evaluation relies on the HA’s
previous safety & efficacy
findings reported for the RLD.
• This criterion only applies
when the new product & the
RLD are bioequivalent, &
possess identical
characteristics:
• AI
• Dosage form
• Strength
• Route of administration
• Uses
Medicinal drugs based on a generic molecule & have a
different route of administration, format, strength, or
indication from the original reference product. They
require re-approval for market authorization, partly
based on data from the original reference product &
partly on data from new clinical trials on the modified
version.
BA studies vs. approved RLD:
• If the new formulation is bioequivalent to the RLD &
the indication is the same, the number of subsequent
studies is greatly reduced.
• If they are not bioequivalent, safety & efficacy needs
to be established & submission requirements may
include preclinical & clinical efficacy studies.
22-Feb-24
Hybrid applications under Article 10(3) of Directive 2001/83/EC differ from
generic applications in that the results of appropriate pre-clinical tests &
clinical trials will be necessary in the following three circumstances:
where the strict definition of a 'generic medicinal product ' is not met;
where the BA studies cannot be used to demonstrate BE ;
where there are changes in the active substance (s), therapeutic indications
, strength, pharmaceutical form or route of administration of the generic
product compared to the reference medicinal product .

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Product type- Drug development - Departments of facility- Registration pathway - Regulatory Affairs

  • 1. CTD, NeeS & eCTD Compilation & submission of the dossiers Dr. Asmaa Khalil, M.Sc. RA Manager – CTD , NeeS & eCTD Instructor
  • 2.  Regulatory Affairs Manager.  B.S. in Pharmaceutical Sciences from Cairo University.  M.Sc. in Biochemistry.  19 Years experience in the pharmaceutical field.  Expert in CTD, NeeS & eCTD compilation & submission of dossiers.  Speaker of more than 64 workshops in Egypt & GCC for RA, CTD/eCTD sessions and pharmaceutical field. Asmaa Khalil El-Kersh
  • 3. • All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country. • The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health. Medicines
  • 4. Manufacturing site departments Warehouse Production & Engineering QA QC PV Medical Affairs Artwork/Labelling RA Marketing
  • 6. Story of Diseases & Medicines Step 1: Discovery & Development Step 2: Preclinical Research Step 3: Clinical Research Step 5: Post-marketing-Safety Monitoring Step 4: Government review
  • 7. Step 1: Discovery & Development Researchers try to identify the disease Research for a new drug begins in the laboratory through designing a product to stop or reverse the effects of the disease Innovator product
  • 8. Step 2: Preclinical Research Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm (toxicity). Drugs undergo laboratory & animal testing to answer basic questions about safety. These studies must provide detailed information on dosing & toxicity levels. After preclinical testing, researchers review their findings & decide whether the drug should be tested in people. Innovator product
  • 9. Step 3: Clinical Research Step 4: Post-marketing-Safety Monitoring • Purpose: safety & dosage • Study Participants: 20 to 100 healthy volunteers or people with the disease/condition. • Length of Study: several months • Approximately 70% of drugs move to the next phase Drugs are tested on people to make sure they are safe & effective. • Purpose: efficacy & side effects • Study Participants: several hundred patients • Length of Study: several months to two years • Approximately 33% of drugs move to the next phase • Trials test for effectiveness & monitoring of adverse reactions • Study Participants: 300 to 3,000 patients • Length of Study: 1 to 4 years • Approximately 25- 30% of drugs move to the next phase • Trials test for safety & efficacy • Study Participants: Several thousand volunteers who have the disease/condition • Post Marketing Surveillance Trials: after a drug or device has been approved for consumer sale. Innovator & Generic product
  • 10. Research for a new drug begins in the laboratory. Drugs undergo laboratory & animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe, effective, monitoring of ADRs, the effectiveness of dose FDA review teams thoroughly examine all of the submitted data related to the drug or device & make a decision to approve or not to approve it. FDA monitors all drug & device safety once products are available for use by the public 22-Feb-24
  • 12. RA is responsible to revise, compile & submit the registration file of drug product and manufacturing site “if required” to Health authority (HA), as to grant the MA / GMP. Companies Global HA Link R A Link RA 22-Feb-24 Responsibility of RA
  • 13. Regulatory Affairs RA is a profession developed: by the companies responsible for the discovery, testing, manufacture & marketing of these products wanting to ensure that they supply products that are safe & make a worthwhile contribution to public health. from the desire of governments to protect public health by controlling the safety & efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides & cosmetics.
  • 14. What is the strategy of RA? Plan for: • Registration of product in the global market (to be in line with corporate, business and strategy of RA unit & projects). • Developing the product with the goal of obtaining regulatory approval in desired markets “new molecular entities (chemical & biopharmaceutical), drug rediscovery”. • Lifecycle management/maintenance post approval “maintenance of existing products, new indications, new API (Active Pharmaceutical Ingredient) suppliers, new markets, line extensions, variations & site transfers”. • Balance time & cost & human resources.
  • 15. Regulatory Affairs • Business development • Marketing & Sales •Medical / Clinical • R&D • QA / QC / Compliance •Pharmacovigilance • Manufacturing sites • Supply Chain “SC” • Labeling • Finance Legal • Logistics • HR • Customer service International Regulatory Agencies Regulatory Health Authorities 22-Feb-24 Interactions with RA
  • 16. Regulatory Affairs The Link Between Pharma Companies & Governmental Authorities
  • 17. Support & follow up with HAs, as to submit all dossiers of: • MAH &/or manufacturing sites registration; • Product's registration / renewal/ variation / price ; • Replying & responding to all received inquiries from HAs; • Provides support to tender & importation requests. until receiving registration license /approval. Prepare /compile/ revise / submit Registration doc. to regulatory authorities Optimizing & speeding “time to market” strategic thinking & definitions of regulatory strategies Give strategic & technical advice to R&D, QC, QA, Production , SC & Medical Affairs Keep track on every update in international authorities guidelines Participating in: • Manufacturing site & portfolio optimization activities. • Merger, Demerger & Divestment activities. What is the role of Regulatory Affairs ? Perform integral roles throughout healthcare product lifecycle at every stage of development, distribution, marketing & post market surveillance of drugs, medical devices, biotechnology products & other vital medical treatments. Identification of various regulatory options for drug development. Distribution of approval documents / certificates & regulatory documents archiving.
  • 19. Evaluation/ Inspection/ Testing HAs regulations mainly cover the mentioned below activities: • Pre-marketing evaluation of the quality, safety and efficacy of a medicine, including compliance of manufacturing sites & processes with GMP standards. • Assessment & inspection of all components of the SC “manufacturing sites/laboratories/CDMO”. • Maintenance of a registered products and post-marketing surveillance activities, including random sampling of registered medicines for QC & PV. • Promotion, advertising & marketing of medicines information. • Price control Submission / Publishing Business validation Technical validation Pricing Licensing Post- marketing Model isn’t unified, it may be changed depending on each HA process. 22-Feb-24
  • 20. Product Type Innovator =Originator = Brand Generic Hybrid • Pre-clinical & Clinical study • Non-Clinical study • BA study The above mentioned studies are requested for innovator product. A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality & performance characteristics. BE studies vs. approved Reference Listed Drug (RLD): • Once BE is conducted, evaluation relies on the HA’s previous safety & efficacy findings reported for the RLD. • This criterion only applies when the new product & the RLD are bioequivalent, & possess identical characteristics: • AI • Dosage form • Strength • Route of administration • Uses Medicinal drugs based on a generic molecule & have a different route of administration, format, strength, or indication from the original reference product. They require re-approval for market authorization, partly based on data from the original reference product & partly on data from new clinical trials on the modified version. BA studies vs. approved RLD: • If the new formulation is bioequivalent to the RLD & the indication is the same, the number of subsequent studies is greatly reduced. • If they are not bioequivalent, safety & efficacy needs to be established & submission requirements may include preclinical & clinical efficacy studies. 22-Feb-24
  • 21. Hybrid applications under Article 10(3) of Directive 2001/83/EC differ from generic applications in that the results of appropriate pre-clinical tests & clinical trials will be necessary in the following three circumstances: where the strict definition of a 'generic medicinal product ' is not met; where the BA studies cannot be used to demonstrate BE ; where there are changes in the active substance (s), therapeutic indications , strength, pharmaceutical form or route of administration of the generic product compared to the reference medicinal product .