It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
Preclinical and Clinical Development Consideration in Herbals & Biologics in USAanjaliyadav012327
It is overview of preclinical and clinical development consideration for herbals and biologics in USA.
In this details discussion of preclinical and clinical consideration in USA. This is belong to Subject Regulatory Aspects of Herbals and Biologics
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
Preclinical and Clinical Development Consideration in Herbals & Biologics in USAanjaliyadav012327
It is overview of preclinical and clinical development consideration for herbals and biologics in USA.
In this details discussion of preclinical and clinical consideration in USA. This is belong to Subject Regulatory Aspects of Herbals and Biologics
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
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A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
Bruno Flamion, Professor of Physiology and Pharmacology, Molecular Physiology Research Unit, University of Namur
Presentation at EIPG – VAPI-UPIP Symposium “Biotech and Advanced Therapies: Challenges and Opportunities” at the Faculty of Medicine and Pharmacy, Campus Jette, Vrije Universiteit van Brussel, Brussels 2013
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptxDimple Marathe
organization, structure, function of FDA, FR, CFR, FFDCA, Approval process of IND, NDA, ANDA, orphan drug, combination product, changes to approved NDA, ANDA, packaging labelling of pharmaceutical.
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
Bruno Flamion, Professor of Physiology and Pharmacology, Molecular Physiology Research Unit, University of Namur
Presentation at EIPG – VAPI-UPIP Symposium “Biotech and Advanced Therapies: Challenges and Opportunities” at the Faculty of Medicine and Pharmacy, Campus Jette, Vrije Universiteit van Brussel, Brussels 2013
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
Quality Safety Efficacy Multidisciplinary (Q S E M)
ICH Q1 Stability
Case toxicity of ethylene glycol and diethylene glycol in cough syrup.
accelerated stability studies
constant interval method
Bioequivalence studies for various pharmaceutical drug formulations manufactured and released into the market is outlined in this presentation. The various studies used to establish bioequivalency with the original formulation is also mentioned.
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ICH guidelines for stability studies of different formulation and active pharmaceuticals.
physical, chemical, microbial, toxicological therapeutic stability studies.
accelerated and intermediate, long term stability studies
by following the stability studies we can predict the expiry period and half life of product and avoid the toxic effect of the unstable product
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Stability plays an important role in the drug development process. Present work aims to compare the stability
testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory
agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and
European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability
testing requirements for new drug substance and drug product. WHO guidelines describe stability testing
requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information
to be submitted in original and subsequent applications for marketing authorization of their related Finished
pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters
like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term
storage condition (general case) and accelerated storage conditions (substance/product intended to be stored
in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along
with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and
real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on
stability testing requirements for new active substance and related products. It sets out the stability testing
requirements for existing active substance and related finished product. The minimum time period to be covered
by data at the time of submission during long term storage conditions differs from ICH guidelines.
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Gaseous wastes
Solid wastes.
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Based on their sources of origin
Based on physical nature
SYSTEMS FOR SOLID WASTE MANAGEMENT:
METHODS FOR DISPOSAL OF THE SOLID WASTE:
OPEN DUMPS:
LANDFILLS:
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COMPOSTING
Different stages of composting
VERMICOMPOSTING:
Vermicomposting process:
Encapsulation:
Incineration
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Refuse
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Recycle
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Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
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3. PK- Pharmacokinetics
PD- Pharmacodynamics
ADME- (Absorption, Distribution, Metabolism, Elimination)
EFD- Embryo Fetal Development
NHP- Non-Human Primates
GCP- Good Clinical Practice
EMA- European Medical Agency
EU- European Union
CTD- Common Technical Document
ABBREVIATIONS:
3
4. INTRODUCTION
BIOLOGICS:
They are medical products. Many biologics are
made from a variety of natural sources (human,
animal or microorganism).Like drugs, some
biologics are intended to treat disease & medical
conditions. Other biologics are used to prevent or
diagnose diseases.
Example – Vaccines, Blood & Blood Products, gene
therapies, cellular therapies.
4
5. STABILITY OF BIOLOGICS
Stability: Ability of a pharmaceutical product to retain
its chemical, physical, microbiological and
biopharmaceutical properties within specified limits
throughout its shelf-life.
• Manufacturers should provide- stability indicating
profile which helps to detect changes in the product.
• Applicants should provide sufficient validated data of
stability and review it properly.
5
6. STABILITY OF BIOLOGICS:
Protocol: It includes all the necessary information which
depicts the stability of the biological product also about
the expiration date of the product.
Also describes specifications of the product.
Potency: Ability or capacity of the product to achieve its
intended effect.
6
7. STABILITY OF BIOLOGICS
Product’s Characteristics:
• Visual Appearance (colour/opacity of
solutions/suspensions
• PH
• Moisture Levels (powders, lyophilised products)
• Sterility testing of the container closure – to get the
proper shelf life of the product.
7
8. STABILITY OF BIOLOGICS:
Storage Conditions:
• Temperature: Most biologics need defined storage
temperatures.
• Humidity: Biologics are distributed in containers
protecting against humidity. Stability data is
mandatory if container are not protecting against
humidity.
• Light: Depends on type of the product.
8
9. TYPES OF STABILITY
STUDIES:
1. Long term Testing: Known as Real Time Testing.
performed for longer duration.
Test period depends upon the stability of the product
which is long and can indicate that no degradation occurs.
2. Accelerated Testing: Helps to predict shelf-life or used
to compare stability of alternative formulation.
7
10. TYPES OF STABILITY
STUDIES:
3. Intermediate Testing: This test is performed when
accelerated test fails at 25°C for a longer duration.
4. Stress Testing: Helps to identify the degradation of the
product.
10
11. STABILITY TESTING
REQUIREMENTS
Sr.No Parameters Drug Substance Drug Product
1. Stress Testing Temperature: 50°C,
60°C,70°C
Humidity: 25°C/75%RH &
25°C/90% RH
Oxidation: Required
according to the condition.
Photo stability: Should be
carried out on a single
batch.
Temperature: 50°C, 60°C
for 1 month.
Humidity: 40°C/75%RH &
25°C/80% RH
Photo stability should be
carried out.
11
12. STABILITY TESTING
REQUIREMENTS
Sr.No Parameters Drug Substance Drug Product
2. Selection of batches Data should be provided
on at least 3 primary
pilot scale batch.
Data should be provided
on at least 3 primary
batches.
2 should be at least pilot
scale batches.
3. Container Closure System Stability testing should be
carried out in the same
container closure system
as that proposed for
storage & distribution.
Container closure system for
testing should be same as that
proposed for marketing including
any secondary packaging.
12
13. 4. Specification It is the list of tests &
proposed acceptance
criteria which the drug
substance should meet.
It is the list of tests & proposed acceptance
criteria which the drug product should
meet.
5. Testing
Frequency:
Long Term studies: 0,
3, 6, 9,12,18,24 months
& annually through the
proposed re-test period.
Accelerated : 0, 3, 6
months
Intermediate : 0, 6, 9,
12 months
Long Term studies: 0, 3, 6, 9,12,18,24
months & annually through the proposed
re-test period.
Accelerated : 0,3,6 months
Intermediate : 0,6,9,12 months
STABILITY TESTING
REQUIREMENTS
13
14. 6. Storage
Conditions:
a. General Case:
Long Term- 25°C/60%RH or 30°C/
65%RH
Intermediate- 30°C/65%RH
Accelerated -40°C/ 75% RH
a. Freeze condition:
Long Term- 5°C
Accelerated Term- 25°C/ 60% RH
a. Freezer: -20°C
Storage condition for general case for the
product intended to be stored in refrigerator &
freezer is same as for drug product.
7. Stability
Commitment
If the data does not cover the proposed
retest period granted at the time of
approval a committed should be made to
continue the stability testing.
If the data does not cover the proposed shelf-
life granted at the time of approval committed
should be made to continue the long term
studies through proposed shelf-life, the
accelerated studies for 6 months.
STABILITY TESTING
REQUIREMENTS
14
15. 8. Evaluation Based on evaluation of data
re-test period should be
established.
Based on evaluation of data shelf- life should
be established.
9. Labelling A storage statement should be
established based on stability
evaluation of drug substance.
A storage statement should be established
based on stability evaluation of drug product.
STABILITY TESTING
REQUIREMENTS
15
16. SAFETY OF BIOLOGICS:
For evaluating safety of biologics preclinical and clinical
studies are done.
A) Preclinical Studies:
It is also known as non-clinical studies. It is conducted
prior clinical trials It contains following of the
parameters.
16
17. A) PRECLINICAL STUDIES:
. 1. Study Design
2. Pharmacology Studies
3. Selection of Species
4. Number/Gender of Animals
5. Dose Selection
17
18. A) PRECLINICAL STUDIES:
6. Immunogenicity
7. Single Dose Toxicity
8. Immunotoxicity Studies
9. Local Tolerance Studies
10. Reproductive and Developmental
toxicity
18
19. A)PRECLINICAL STUDIES:
1. Study Design:
• For conducting any kind of study , study design plays
an important role.
• Helps for easy evaluation and assessment of the
results.
• While designing study , PK-PD approaches should
be considered.
• Clinical Trials should be conducted easily using the
study design.
19
20. A) PRECLINICAL STUDIES:
2. Pharmacology Studies:
• Evaluates the biologics potential adverse effects on vital
functions of the body.
• Special assays and biomarkers are used to access safety
concerns of biologics.
• Helps identify potential risk and gives guidance for
selecting a proper dose for clinical trials.
• Pharmacokinetic properties are also evaluated of the
biologics (ADME) data.
20
21. A) PRECLINICAL STUDIES:
3. Animal Species/Model Selection:
• Sponsor should select relevant species for preclinical
trials.
• A relevant species is one in which the test material is
pharmacologically active.
• A variety of techniques (e.g., immunochemical or
functional tests) can be used to identify a relevant
species.
21
22. A) PRECLINICAL STUDIES:
4. Number/Gender of the animal:
• The number of animal used per dose should have the
ability to detect toxicity.
• Small sample size – failure to observe toxicity.
• Both genders should be used and if not justification
should be provided.
22
23. A) PRECLINICAL STUDIES:
5. Dose Selection:
• Dosage levels – To provide information on dose-
response relationship.
• Ideal dosage range for further trials is based on
preclinical evaluation.
• Optimal dose selection is crucial to ensure more
therapeutic efficacy while minimizing potential
adverse events.
• All PK-PD characteristics are also considered.
23
24. A) PRECLINICAL STUDIES:
6. Immunogenicity:
• Many biologics intended for human are immunogenic in
animals.
• Evaluations of immunogenicity determine whether a
biologics has a capacity to induce into the immune system
of the species or not (preclinical trial).
• Assessments are done in accordance with regulatory
guidelines.
• Techniques like ELISA, cell based are used for the same.
24
25. A) PRECLINICAL STUDIES:
7. Single Dose Toxicity :
• Single dose studies may generate useful data to
describe the relationship of dose to systemic and/or
local toxicity.
• These data can be used to select doses for repeated
dose toxicity studies.
25
26. A) PRECLINICAL STUDIES:
8. Immunotoxicity Studies :
• Many biologics are intended to stimulate or supress the
immune system.
• Toxic effects can be caused by formulation vehicle
which may result in the toxic changes at the site of
infection.
• Immunotoxicological Testing strategies are required to
clarify issues.
26
27. A) PRECLINICAL STUDIES:
9. Local Tolerance Studies :
• Studies are done to check the local tolerance of the drug.
• Data of single dose and repeated dose can also be used to
evaluate the study.
27
28. A) PRECLINICAL STUDIES:
10. Reproductive and Developmental toxicity :
• Provides general advice on reproductive toxicity.
• Fertility Studies
• Embryo- Fetal Developmental Studies (EFD)
• Pre and post natal developmental studies
• Non-human primates studies (NHP)
28
29. SAFETY OF BIOLOGICS:
For evaluating safety of biologics preclinical and clinical tests
are done.
B) Clinical Studies:
Biologics need to undergo clinical trials before a marketing
authorization application.
Following are the considerations:
29
30. B) CLINICAL STUDIES:
1. Clinical Trial Authorization
2. GCP and other aspects
3. Study Design Considerations
4. Consultation with EMA
30
31. B) CLINICAL STUDIES:
1. Clinical Trial Authorization:
• Trials begins when:
• Subjects understands the objective and risk of the trial
and give their informed consent.
• The physical and mental integrity of the subjects
should be maintained.
31
32. B) CLINICAL STUDIES:
2. GCP and other aspects of trials:
• Clinical trials of biologics must comply with GCP and
the ICH E6.
• Clinical trial information must be handled, recorded
and stored with all the privacy rules.
• Trials must comply ethical principles (benefits & risk
ratio) ensuring safety of subjects.
• Investigators must obtain freely given consent from
every subject before the trial.
32
33. B) CLINICAL STUDIES:
3. Study Design Considerations :
• Phase I - involves the initial safety and PK studies.
• Phase II study is a therapeutic exploratory study that
explores efficacy.
• Phase III - involves therapeutic confirmatory studies.
33
34. B) CLINICAL STUDIES:
4. Consultation with EMA:
• A sponsor may obtain scientific advice regarding
clinical trial protocols from the EMA
• The agency remarks will only address scientific issues
and will focus on matters such as selection of endpoints,
comparator, duration of treatment or follow-up.
34
35. C) MARKETING AUTHORIZATION
APPLICATION:
1. The requirements of EU centralised procedure:
• The approval standards for biotechnology products are
the same as for chemically synthesized medicines.
• Both types of products must be safe and effective and
have appropriate quality.
35
36. C) MARKETING AUTHORIZATION
APPLICATION:
2. MAA for biologics must meet the standard dossier
submission requirements:
MAA must comply with CTD format
• Module 1(Administrative info, including labelling).
• Module 2 (various summaries)
• Module 3 (chemical, pharmaceutical and biological
information)
• Module 4 (non-clinical reports)
• Module 5 (clinical study reports) 36
37. ADVERTISING OF BIOLOGICS:
Advertising of medicinal products shall include any
information which is designed to promote the prescription,
supply, sale or consumption of medicinal products.
• Advertising is done for general public.
• Done for qualified personnel which helps them to
prescribe or supply the product.
• Member States prohibits the product which is not
according to the regulation.
37
38. ADVERTISING OF BIOLOGICS:
• All parts of the advertising of a medicinal product must
comply with product’s characteristics.
• Advertising shall encourage the rational use of the
product.
• It should not be misleading.
38
39. ADVERTISING OF BIOLOGICS:
Advertisement which include therapeutic indications
should be prohibited for example disease like:
1. Tuberculosis
2. Sexually Transmitted Diseases
3. Other serious infectious diseases
4. Cancer and other tumoral diseases
5. Chronic Insomnia
6. Diabetes and many others.
39
40. LABELLING AND PACKAGING OF
BIOLOGICS:
The following particulars shall appear on the outer packaging
of medicinal products or on immediate packaging.
1. Name of the medicinal product.
2. Type of dosage form, weight, volume and dose of the
product.
3. List of excipients used in the product.
4. Route of Administration
40
41. LABELLING AND PACKAGING OF
BIOLOGICS:
5. Special Warnings about the product
6. Expiry date in clear terms (month/year)
7. Special Storage Conditions
8. Special Precautions for disposal of unused or waste
products from the product.
9. Name and address of the Market Holder for placing
product in the market.
10. Manufacturer’s Batch Number
41
42. LABELLING AND PACKAGING
OF BIOLOGICS:
11. The price of the medicinal product.
12. Information about contra-indications.
13. Information about interactions that can cause
adverse drug reaction.
42
43. LABELLING AND PACKAGING
OF BIOLOGICS:
• Warning against using the product after the expiry date.
• Warning against certain visible signs of deterioration
• The date on which the package leaflet was last revised.
• Package leaflet must be written in clear and understandable
terms for the users and all the regulatory laws should be
followed.
43
44. Comparison of Biologics in EU & USA
Information About: EU USA
Advertising Direct to consumer advertising is prohibited. Direct to consumer advertising is
permitted.
EU prioritizes healthcare professionals as the
primary audience for drug promotion.
FDA require advertisements
include fair balance, risks and
benefits, along with specific safety
standard.
Done through conferences, publications and
educational materials
Done through Television, print,
media, social media etc.
44
45. Comparison of Biologics in EU & USA
Information About: EU USA
Labelling EU labelling requirements focus on providing
comprehensive information for healthcare
professionals and patients.
FDA approved labelling for
biologics must adhere to specific
regulations outlined in CFR
Title 21.
EU labels may include information on storage
conditions, shelf-life, specific handling
instructions.
US labels may contain boxed
warnings, medication guides
for patients , administration,
dosage etc.
Packaging Involves product details , strength , dosage form,
storage form along with Patient Information
Leaflet(PIL)
Must comply with CFR 21
including details about product
along with warnings and
storage conditions.
PIL gives information about use of medicine,
side effects, precautions etc.
Packaging involves barcodes for
inventory control, tamper-seal
and other information about
packaging. 45
46. REFERENCES:
1. ICH Topic Q 5 C Quality of Biotechnological Products: Stability Testing of
Biotechnological/Biological Products Step 5 note for guidance on quality of
biotechnolo-gical products: stability testing of biotechnological/biological
products final approval by cpmp december 1995 proposed date for coming into
operation
2. International conference on harmonisation of technical requirements for
registration of pharmaceuticals for human use preclinical safety evaluation of
biotechnology-derived pharmaceuticals s6(r1)
3. Requirements for quality documentation concerning biological investigational
medicinal products in clinical trials - Scientific guideline | European Medicines
Agency
46
47. REFERENCES:
4. Non-clinical guidelines | european medicines agency
5. DIRECTIVE 2001/83/EC OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 6
novemeber 2001 on the community code relating to
medicinal products for human use.
47