SlideShare a Scribd company logo
1 of 11
By D. Saidulu
Rule

Permission for

122 A

To import New drugs

122 B

To manufacture New drugs

122 D

To Import or Manufacture fixed
dose combinations

122DA

To conduct clinical trials for New
Drug/Investigational New drug

122 DAA

Definition of Clinical Trial
Application for permission

Clinical Trial

Studies in Specific Population

Post Marketing Surveillance

Special Studies : BA/BE studies
It shall made in Form 44 accompanied with the
following data in accordance with appendices, namely
 Clinical and pharmaceutical information
 Animal pharmacology data
 Animal Toxicology data
 Human Clinical pharmacology data

 Regulatory status in other countries
 Prescribing information

 FORM 12- To import Study drug for examination , test or

analysis
1. Approval for Clinical trials
 CT on a New drug shall be initiated only after permission by licensing

authority and approval from EC

2. Responsibilities of Sponsor
 Implementing and maintaining QA
 Submit status report to the licensing authority periodically
 SAE should be reported to the licensing authority with in 14 calendar days.

3. Responsibilities of Investigator
 Ensure adequate medical care is provided to the subject
 SAE and unexpected AE should be reported to the sponsor within 24 hrs and

to the EC within 7 working days

4.Informed consent
 Freely given informed written consent

 Provide information about the study verbally
 Non-Technically and understandable language
 5.Responsibilities of ethics committee

 Approval trial protocol to safe guard RSW of all trial subject and to

protect RSW of all vulnerable subjects
 Conduct ongoing review of trials
 6. Human Pharmacology (Phase I)

 Safety and tolerability
 7. Therapeutic exploratory trials (phase II)

 To evaluate the effectiveness of a drug for a particular indication
 To determine the short term side effects and risk associated with the

drug
 To determine the dosage regimen for phase III trials.
 8. Therapeutic confirmatory trials (phase III)

 Demonstration of therapeutic benefit
 Drug is safe and effective for use and provide and adequate basis for

marketing approval
 9. Post marketing surveillance

 Performed after drug approval and related to the approved indication
 Includes drug-drug interaction, dosage response and safety studies ,

mortality/ morbidity studies
 3. studies in special population

 1. Geriatrics
 2. Pediatrics
 3. pregnant or Nursing Women

4. Post marketing Surveillance
 closely monitored new drugs clinical safety
 PSUR- to report all relevant new information
 PSUR shall be submitted every 6months for the first 2 years
5. Special Studies- BA/BE studies
 conducted according to the guidance for BA and BE studies
 Evaluation of the effect of food on absorption following oral
administration


APPENDIX I- Data to be submitted along with the application to conduct clinical trial/import/ manufacture of new
drugs for marketing in the country.



APPENDIX I- Data required to be submitted by an applicant for grant of permission to import and/ or manufacture a
new drug already approved in the country.



APPENDIX II- Structure , contents and format for clinical Study Reports.



APPENDIX III- Animal toxicology (Non- Clinical Toxicity studies)



APPENDIX IV- Animal Pharmacology



APPENDIX V- Informed Consent



APPENDIX VI- Fixed Dose combinations (FDC)



APPENDIX VII- Undertaking by Investigator



APPENDIX VIII- Ethics Committee



APPENDIX IX- Stability testing of New Drugs



APPENDIX X- Contents of the proposed protocol for conducting clinical trials



APPENDIX XI- Data elements for reporting serious adverse events occurring in a Clinical trial
Schedule y
Schedule y

More Related Content

What's hot

ICH: Introduction, objectives & guidelines: A brief insight.
ICH: Introduction, objectives & guidelines: A brief insight.ICH: Introduction, objectives & guidelines: A brief insight.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
 
Investigational New Drug Application
Investigational New Drug ApplicationInvestigational New Drug Application
Investigational New Drug ApplicationSuhas Reddy C
 
New Drug Application [NDA]
New Drug Application [NDA]New Drug Application [NDA]
New Drug Application [NDA]Sagar Savale
 
Schedule Y by akshdeep sharma
Schedule Y by akshdeep sharmaSchedule Y by akshdeep sharma
Schedule Y by akshdeep sharmaAkshdeep Sharma
 
INVESTIGATOR’S BROCHURE (IB)
 INVESTIGATOR’S BROCHURE (IB) INVESTIGATOR’S BROCHURE (IB)
INVESTIGATOR’S BROCHURE (IB)SachinFartade
 
Clinical trial protocol development
Clinical trial protocol developmentClinical trial protocol development
Clinical trial protocol developmentSACHIN C P
 
Adr reporting ppt
Adr reporting pptAdr reporting ppt
Adr reporting pptRimaSingh14
 
Establishing Pharmacovigilance Centres In Hospital.pptx
Establishing Pharmacovigilance Centres In Hospital.pptxEstablishing Pharmacovigilance Centres In Hospital.pptx
Establishing Pharmacovigilance Centres In Hospital.pptxRushikeshTidake
 
1. Unit I - new drug discovery and development.
1. Unit I - new drug discovery and development.1. Unit I - new drug discovery and development.
1. Unit I - new drug discovery and development.Audumbar Mali
 
Clinical trials its types and designs
Clinical trials  its types and designsClinical trials  its types and designs
Clinical trials its types and designsDevesh Aggarwal
 
Investigator's Brochure
Investigator's BrochureInvestigator's Brochure
Investigator's BrochureRiyaz Gohil
 
Detection, reporting and management of adverse events
Detection, reporting and management of adverse eventsDetection, reporting and management of adverse events
Detection, reporting and management of adverse eventsKatla Swapna
 
Drug regulatory authority
Drug regulatory authority Drug regulatory authority
Drug regulatory authority Rahul Gawande
 
METHODS OF POST MARKETING SURVEILLANCE
METHODS OF POST MARKETING SURVEILLANCEMETHODS OF POST MARKETING SURVEILLANCE
METHODS OF POST MARKETING SURVEILLANCEDr Arathy R Nath
 
History and progress of pharmacovigilance
History and progress of pharmacovigilanceHistory and progress of pharmacovigilance
History and progress of pharmacovigilanceGagandeep Jaiswal
 
Safety monitoring in clinical trails
Safety monitoring in clinical trailsSafety monitoring in clinical trails
Safety monitoring in clinical trailsGOURIPRIYA L S
 

What's hot (20)

Cdsco ppt
Cdsco pptCdsco ppt
Cdsco ppt
 
ICH: Introduction, objectives & guidelines: A brief insight.
ICH: Introduction, objectives & guidelines: A brief insight.ICH: Introduction, objectives & guidelines: A brief insight.
ICH: Introduction, objectives & guidelines: A brief insight.
 
Investigational New Drug Application
Investigational New Drug ApplicationInvestigational New Drug Application
Investigational New Drug Application
 
New Drug Application [NDA]
New Drug Application [NDA]New Drug Application [NDA]
New Drug Application [NDA]
 
Schedule Y by akshdeep sharma
Schedule Y by akshdeep sharmaSchedule Y by akshdeep sharma
Schedule Y by akshdeep sharma
 
INVESTIGATOR’S BROCHURE (IB)
 INVESTIGATOR’S BROCHURE (IB) INVESTIGATOR’S BROCHURE (IB)
INVESTIGATOR’S BROCHURE (IB)
 
Clinical trial protocol development
Clinical trial protocol developmentClinical trial protocol development
Clinical trial protocol development
 
Adr reporting ppt
Adr reporting pptAdr reporting ppt
Adr reporting ppt
 
Establishing Pharmacovigilance Centres In Hospital.pptx
Establishing Pharmacovigilance Centres In Hospital.pptxEstablishing Pharmacovigilance Centres In Hospital.pptx
Establishing Pharmacovigilance Centres In Hospital.pptx
 
CONTRACT RESEARCH ORGANIZATION
CONTRACT RESEARCH ORGANIZATIONCONTRACT RESEARCH ORGANIZATION
CONTRACT RESEARCH ORGANIZATION
 
Pharmacovigilance methods
Pharmacovigilance methodsPharmacovigilance methods
Pharmacovigilance methods
 
1. Unit I - new drug discovery and development.
1. Unit I - new drug discovery and development.1. Unit I - new drug discovery and development.
1. Unit I - new drug discovery and development.
 
Clinical trials its types and designs
Clinical trials  its types and designsClinical trials  its types and designs
Clinical trials its types and designs
 
Investigator brochure
Investigator brochureInvestigator brochure
Investigator brochure
 
Investigator's Brochure
Investigator's BrochureInvestigator's Brochure
Investigator's Brochure
 
Detection, reporting and management of adverse events
Detection, reporting and management of adverse eventsDetection, reporting and management of adverse events
Detection, reporting and management of adverse events
 
Drug regulatory authority
Drug regulatory authority Drug regulatory authority
Drug regulatory authority
 
METHODS OF POST MARKETING SURVEILLANCE
METHODS OF POST MARKETING SURVEILLANCEMETHODS OF POST MARKETING SURVEILLANCE
METHODS OF POST MARKETING SURVEILLANCE
 
History and progress of pharmacovigilance
History and progress of pharmacovigilanceHistory and progress of pharmacovigilance
History and progress of pharmacovigilance
 
Safety monitoring in clinical trails
Safety monitoring in clinical trailsSafety monitoring in clinical trails
Safety monitoring in clinical trails
 

Viewers also liked

Viewers also liked (13)

Schedule Y
Schedule YSchedule Y
Schedule Y
 
Schedule Y
Schedule YSchedule Y
Schedule Y
 
Cdsco- a regulatory overview
Cdsco- a regulatory overviewCdsco- a regulatory overview
Cdsco- a regulatory overview
 
CDSCO and ADR reporting in India
CDSCO and ADR reporting in IndiaCDSCO and ADR reporting in India
CDSCO and ADR reporting in India
 
Schedule y, mk sharma
Schedule y, mk sharmaSchedule y, mk sharma
Schedule y, mk sharma
 
Summary Of Schedule Y
Summary Of Schedule YSummary Of Schedule Y
Summary Of Schedule Y
 
Schedule y
Schedule ySchedule y
Schedule y
 
Schedule y -_priti_gupta
Schedule y -_priti_guptaSchedule y -_priti_gupta
Schedule y -_priti_gupta
 
Emea
EmeaEmea
Emea
 
Code of federal regulations {cfr}
Code of federal regulations {cfr}Code of federal regulations {cfr}
Code of federal regulations {cfr}
 
21 CFR PART 11
21 CFR PART 1121 CFR PART 11
21 CFR PART 11
 
Schedule Y
Schedule YSchedule Y
Schedule Y
 
Pharmacovigilance full information
Pharmacovigilance full informationPharmacovigilance full information
Pharmacovigilance full information
 

Similar to Schedule y

Schedule y under drugs and cosmetic act 1945
Schedule y  under drugs and cosmetic act 1945Schedule y  under drugs and cosmetic act 1945
Schedule y under drugs and cosmetic act 1945neelotpal31
 
PART 1 _ Documentation of drug trials and regulatory filings (1).pptx
PART 1 _ Documentation of drug trials and regulatory filings (1).pptxPART 1 _ Documentation of drug trials and regulatory filings (1).pptx
PART 1 _ Documentation of drug trials and regulatory filings (1).pptxDilsarGohil1
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
 
Global Subbmission of IND, NDA, ANDA
Global Subbmission of IND, NDA, ANDA Global Subbmission of IND, NDA, ANDA
Global Subbmission of IND, NDA, ANDA Maruthi.N
 
IND INDA ANDA Application
IND INDA ANDA ApplicationIND INDA ANDA Application
IND INDA ANDA ApplicationRoshan Bodhe
 
INVESTIGATIONAL NEW DRUG APPLICATION
INVESTIGATIONAL NEW DRUG APPLICATIONINVESTIGATIONAL NEW DRUG APPLICATION
INVESTIGATIONAL NEW DRUG APPLICATIONKomal Yadav
 
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptxGlobal submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptxSANTOSHKUMAR506229
 

Similar to Schedule y (20)

Schedule Y Summary
Schedule Y SummarySchedule Y Summary
Schedule Y Summary
 
Schedule y draft 2
Schedule y draft 2Schedule y draft 2
Schedule y draft 2
 
Dr.s.s amended schedule y
Dr.s.s   amended schedule yDr.s.s   amended schedule y
Dr.s.s amended schedule y
 
Schedule y
Schedule ySchedule y
Schedule y
 
Schedule y jjjjjjjjjjjjjjjjjjjppt
Schedule y jjjjjjjjjjjjjjjjjjjpptSchedule y jjjjjjjjjjjjjjjjjjjppt
Schedule y jjjjjjjjjjjjjjjjjjjppt
 
Schedule Y-2019
Schedule Y-2019Schedule Y-2019
Schedule Y-2019
 
Schedule Y
Schedule YSchedule Y
Schedule Y
 
Seminar schedule 'y'
Seminar schedule   'y'Seminar schedule   'y'
Seminar schedule 'y'
 
Indstudies
Indstudies Indstudies
Indstudies
 
INDA/NDA/ANDA
INDA/NDA/ANDAINDA/NDA/ANDA
INDA/NDA/ANDA
 
Scedule y
Scedule yScedule y
Scedule y
 
schedule y
schedule yschedule y
schedule y
 
Schedule y under drugs and cosmetic act 1945
Schedule y  under drugs and cosmetic act 1945Schedule y  under drugs and cosmetic act 1945
Schedule y under drugs and cosmetic act 1945
 
PART 1 _ Documentation of drug trials and regulatory filings (1).pptx
PART 1 _ Documentation of drug trials and regulatory filings (1).pptxPART 1 _ Documentation of drug trials and regulatory filings (1).pptx
PART 1 _ Documentation of drug trials and regulatory filings (1).pptx
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
 
Global Subbmission of IND, NDA, ANDA
Global Subbmission of IND, NDA, ANDA Global Subbmission of IND, NDA, ANDA
Global Subbmission of IND, NDA, ANDA
 
IND APPLICATION
IND APPLICATIONIND APPLICATION
IND APPLICATION
 
IND INDA ANDA Application
IND INDA ANDA ApplicationIND INDA ANDA Application
IND INDA ANDA Application
 
INVESTIGATIONAL NEW DRUG APPLICATION
INVESTIGATIONAL NEW DRUG APPLICATIONINVESTIGATIONAL NEW DRUG APPLICATION
INVESTIGATIONAL NEW DRUG APPLICATION
 
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptxGlobal submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
Global submission of IND, NDA ANDA ( Santosh Kumar) (1).pptx
 

More from pharmacologyseminars (20)

Phasesofclincaltrials.
Phasesofclincaltrials.Phasesofclincaltrials.
Phasesofclincaltrials.
 
adverse drug reactions management
adverse drug reactions  managementadverse drug reactions  management
adverse drug reactions management
 
Seminar on Teratogenicity by Sumaraja
Seminar on Teratogenicity by SumarajaSeminar on Teratogenicity by Sumaraja
Seminar on Teratogenicity by Sumaraja
 
carcinogenecity tests
carcinogenecity testscarcinogenecity tests
carcinogenecity tests
 
Jcinvest00098 0136
Jcinvest00098 0136Jcinvest00098 0136
Jcinvest00098 0136
 
Hyaluronidase
HyaluronidaseHyaluronidase
Hyaluronidase
 
Histamine
HistamineHistamine
Histamine
 
Ach1
Ach1Ach1
Ach1
 
Vaso1
Vaso1Vaso1
Vaso1
 
Ach
AchAch
Ach
 
Principles of drug discovery
Principles of drug discoveryPrinciples of drug discovery
Principles of drug discovery
 
Principles of drug discovery
Principles of drug discoveryPrinciples of drug discovery
Principles of drug discovery
 
Progestins
ProgestinsProgestins
Progestins
 
new biological targets by prathyusha .m
new biological targets by prathyusha .mnew biological targets by prathyusha .m
new biological targets by prathyusha .m
 
pharmacogenomics by rajesh .I
pharmacogenomics by rajesh .Ipharmacogenomics by rajesh .I
pharmacogenomics by rajesh .I
 
Bio assay of d-tubocurarine
Bio assay of d-tubocurarineBio assay of d-tubocurarine
Bio assay of d-tubocurarine
 
Genomics
GenomicsGenomics
Genomics
 
Sujana ppt
Sujana pptSujana ppt
Sujana ppt
 
Sujana docx
Sujana docxSujana docx
Sujana docx
 
peptic ulcer doc
 peptic ulcer doc peptic ulcer doc
peptic ulcer doc
 

Recently uploaded

Entrepreneurship lessons in Philippines
Entrepreneurship lessons in  PhilippinesEntrepreneurship lessons in  Philippines
Entrepreneurship lessons in PhilippinesDavidSamuel525586
 
20200128 Ethical by Design - Whitepaper.pdf
20200128 Ethical by Design - Whitepaper.pdf20200128 Ethical by Design - Whitepaper.pdf
20200128 Ethical by Design - Whitepaper.pdfChris Skinner
 
Cybersecurity Awareness Training Presentation v2024.03
Cybersecurity Awareness Training Presentation v2024.03Cybersecurity Awareness Training Presentation v2024.03
Cybersecurity Awareness Training Presentation v2024.03DallasHaselhorst
 
MAHA Global and IPR: Do Actions Speak Louder Than Words?
MAHA Global and IPR: Do Actions Speak Louder Than Words?MAHA Global and IPR: Do Actions Speak Louder Than Words?
MAHA Global and IPR: Do Actions Speak Louder Than Words?Olivia Kresic
 
The McKinsey 7S Framework: A Holistic Approach to Harmonizing All Parts of th...
The McKinsey 7S Framework: A Holistic Approach to Harmonizing All Parts of th...The McKinsey 7S Framework: A Holistic Approach to Harmonizing All Parts of th...
The McKinsey 7S Framework: A Holistic Approach to Harmonizing All Parts of th...Operational Excellence Consulting
 
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...Hector Del Castillo, CPM, CPMM
 
Send Files | Sendbig.comSend Files | Sendbig.com
Send Files | Sendbig.comSend Files | Sendbig.comSend Files | Sendbig.comSend Files | Sendbig.com
Send Files | Sendbig.comSend Files | Sendbig.comSendBig4
 
Memorándum de Entendimiento (MoU) entre Codelco y SQM
Memorándum de Entendimiento (MoU) entre Codelco y SQMMemorándum de Entendimiento (MoU) entre Codelco y SQM
Memorándum de Entendimiento (MoU) entre Codelco y SQMVoces Mineras
 
Guide Complete Set of Residential Architectural Drawings PDF
Guide Complete Set of Residential Architectural Drawings PDFGuide Complete Set of Residential Architectural Drawings PDF
Guide Complete Set of Residential Architectural Drawings PDFChandresh Chudasama
 
Driving Business Impact for PMs with Jon Harmer
Driving Business Impact for PMs with Jon HarmerDriving Business Impact for PMs with Jon Harmer
Driving Business Impact for PMs with Jon HarmerAggregage
 
Healthcare Feb. & Mar. Healthcare Newsletter
Healthcare Feb. & Mar. Healthcare NewsletterHealthcare Feb. & Mar. Healthcare Newsletter
Healthcare Feb. & Mar. Healthcare NewsletterJamesConcepcion7
 
Investment in The Coconut Industry by Nancy Cheruiyot
Investment in The Coconut Industry by Nancy CheruiyotInvestment in The Coconut Industry by Nancy Cheruiyot
Investment in The Coconut Industry by Nancy Cheruiyotictsugar
 
NAB Show Exhibitor List 2024 - Exhibitors Data
NAB Show Exhibitor List 2024 - Exhibitors DataNAB Show Exhibitor List 2024 - Exhibitors Data
NAB Show Exhibitor List 2024 - Exhibitors DataExhibitors Data
 
Buy gmail accounts.pdf Buy Old Gmail Accounts
Buy gmail accounts.pdf Buy Old Gmail AccountsBuy gmail accounts.pdf Buy Old Gmail Accounts
Buy gmail accounts.pdf Buy Old Gmail AccountsBuy Verified Accounts
 
Supercharge Your eCommerce Stores-acowebs
Supercharge Your eCommerce Stores-acowebsSupercharge Your eCommerce Stores-acowebs
Supercharge Your eCommerce Stores-acowebsGOKUL JS
 
Introducing the Analogic framework for business planning applications
Introducing the Analogic framework for business planning applicationsIntroducing the Analogic framework for business planning applications
Introducing the Analogic framework for business planning applicationsKnowledgeSeed
 
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...ssuserf63bd7
 
WSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfWSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfJamesConcepcion7
 

Recently uploaded (20)

Entrepreneurship lessons in Philippines
Entrepreneurship lessons in  PhilippinesEntrepreneurship lessons in  Philippines
Entrepreneurship lessons in Philippines
 
20200128 Ethical by Design - Whitepaper.pdf
20200128 Ethical by Design - Whitepaper.pdf20200128 Ethical by Design - Whitepaper.pdf
20200128 Ethical by Design - Whitepaper.pdf
 
Cybersecurity Awareness Training Presentation v2024.03
Cybersecurity Awareness Training Presentation v2024.03Cybersecurity Awareness Training Presentation v2024.03
Cybersecurity Awareness Training Presentation v2024.03
 
MAHA Global and IPR: Do Actions Speak Louder Than Words?
MAHA Global and IPR: Do Actions Speak Louder Than Words?MAHA Global and IPR: Do Actions Speak Louder Than Words?
MAHA Global and IPR: Do Actions Speak Louder Than Words?
 
The McKinsey 7S Framework: A Holistic Approach to Harmonizing All Parts of th...
The McKinsey 7S Framework: A Holistic Approach to Harmonizing All Parts of th...The McKinsey 7S Framework: A Holistic Approach to Harmonizing All Parts of th...
The McKinsey 7S Framework: A Holistic Approach to Harmonizing All Parts of th...
 
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
 
Send Files | Sendbig.comSend Files | Sendbig.com
Send Files | Sendbig.comSend Files | Sendbig.comSend Files | Sendbig.comSend Files | Sendbig.com
Send Files | Sendbig.comSend Files | Sendbig.com
 
Memorándum de Entendimiento (MoU) entre Codelco y SQM
Memorándum de Entendimiento (MoU) entre Codelco y SQMMemorándum de Entendimiento (MoU) entre Codelco y SQM
Memorándum de Entendimiento (MoU) entre Codelco y SQM
 
Guide Complete Set of Residential Architectural Drawings PDF
Guide Complete Set of Residential Architectural Drawings PDFGuide Complete Set of Residential Architectural Drawings PDF
Guide Complete Set of Residential Architectural Drawings PDF
 
Driving Business Impact for PMs with Jon Harmer
Driving Business Impact for PMs with Jon HarmerDriving Business Impact for PMs with Jon Harmer
Driving Business Impact for PMs with Jon Harmer
 
Healthcare Feb. & Mar. Healthcare Newsletter
Healthcare Feb. & Mar. Healthcare NewsletterHealthcare Feb. & Mar. Healthcare Newsletter
Healthcare Feb. & Mar. Healthcare Newsletter
 
Investment in The Coconut Industry by Nancy Cheruiyot
Investment in The Coconut Industry by Nancy CheruiyotInvestment in The Coconut Industry by Nancy Cheruiyot
Investment in The Coconut Industry by Nancy Cheruiyot
 
NAB Show Exhibitor List 2024 - Exhibitors Data
NAB Show Exhibitor List 2024 - Exhibitors DataNAB Show Exhibitor List 2024 - Exhibitors Data
NAB Show Exhibitor List 2024 - Exhibitors Data
 
Buy gmail accounts.pdf Buy Old Gmail Accounts
Buy gmail accounts.pdf Buy Old Gmail AccountsBuy gmail accounts.pdf Buy Old Gmail Accounts
Buy gmail accounts.pdf Buy Old Gmail Accounts
 
Supercharge Your eCommerce Stores-acowebs
Supercharge Your eCommerce Stores-acowebsSupercharge Your eCommerce Stores-acowebs
Supercharge Your eCommerce Stores-acowebs
 
Introducing the Analogic framework for business planning applications
Introducing the Analogic framework for business planning applicationsIntroducing the Analogic framework for business planning applications
Introducing the Analogic framework for business planning applications
 
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
 
WSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfWSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdf
 
The Bizz Quiz-E-Summit-E-Cell-IITPatna.pptx
The Bizz Quiz-E-Summit-E-Cell-IITPatna.pptxThe Bizz Quiz-E-Summit-E-Cell-IITPatna.pptx
The Bizz Quiz-E-Summit-E-Cell-IITPatna.pptx
 
WAM Corporate Presentation April 12 2024.pdf
WAM Corporate Presentation April 12 2024.pdfWAM Corporate Presentation April 12 2024.pdf
WAM Corporate Presentation April 12 2024.pdf
 

Schedule y

  • 2.
  • 3. Rule Permission for 122 A To import New drugs 122 B To manufacture New drugs 122 D To Import or Manufacture fixed dose combinations 122DA To conduct clinical trials for New Drug/Investigational New drug 122 DAA Definition of Clinical Trial
  • 4. Application for permission Clinical Trial Studies in Specific Population Post Marketing Surveillance Special Studies : BA/BE studies
  • 5. It shall made in Form 44 accompanied with the following data in accordance with appendices, namely  Clinical and pharmaceutical information  Animal pharmacology data  Animal Toxicology data  Human Clinical pharmacology data  Regulatory status in other countries  Prescribing information  FORM 12- To import Study drug for examination , test or analysis
  • 6. 1. Approval for Clinical trials  CT on a New drug shall be initiated only after permission by licensing authority and approval from EC 2. Responsibilities of Sponsor  Implementing and maintaining QA  Submit status report to the licensing authority periodically  SAE should be reported to the licensing authority with in 14 calendar days. 3. Responsibilities of Investigator  Ensure adequate medical care is provided to the subject  SAE and unexpected AE should be reported to the sponsor within 24 hrs and to the EC within 7 working days 4.Informed consent  Freely given informed written consent  Provide information about the study verbally  Non-Technically and understandable language
  • 7.  5.Responsibilities of ethics committee  Approval trial protocol to safe guard RSW of all trial subject and to protect RSW of all vulnerable subjects  Conduct ongoing review of trials  6. Human Pharmacology (Phase I)  Safety and tolerability  7. Therapeutic exploratory trials (phase II)  To evaluate the effectiveness of a drug for a particular indication  To determine the short term side effects and risk associated with the drug  To determine the dosage regimen for phase III trials.  8. Therapeutic confirmatory trials (phase III)  Demonstration of therapeutic benefit  Drug is safe and effective for use and provide and adequate basis for marketing approval  9. Post marketing surveillance  Performed after drug approval and related to the approved indication  Includes drug-drug interaction, dosage response and safety studies , mortality/ morbidity studies
  • 8.  3. studies in special population  1. Geriatrics  2. Pediatrics  3. pregnant or Nursing Women 4. Post marketing Surveillance  closely monitored new drugs clinical safety  PSUR- to report all relevant new information  PSUR shall be submitted every 6months for the first 2 years 5. Special Studies- BA/BE studies  conducted according to the guidance for BA and BE studies  Evaluation of the effect of food on absorption following oral administration
  • 9.  APPENDIX I- Data to be submitted along with the application to conduct clinical trial/import/ manufacture of new drugs for marketing in the country.  APPENDIX I- Data required to be submitted by an applicant for grant of permission to import and/ or manufacture a new drug already approved in the country.  APPENDIX II- Structure , contents and format for clinical Study Reports.  APPENDIX III- Animal toxicology (Non- Clinical Toxicity studies)  APPENDIX IV- Animal Pharmacology  APPENDIX V- Informed Consent  APPENDIX VI- Fixed Dose combinations (FDC)  APPENDIX VII- Undertaking by Investigator  APPENDIX VIII- Ethics Committee  APPENDIX IX- Stability testing of New Drugs  APPENDIX X- Contents of the proposed protocol for conducting clinical trials  APPENDIX XI- Data elements for reporting serious adverse events occurring in a Clinical trial