07-10-2010+Schedule+Y_+SA.pdf

SCHEDULE - Y

Aditi Sawardekar

OVERVIEW OF PRESENTATION

• Drug Regulatory Laws

• The Drugs And Cosmetics Act, 1940

• Drugs & Cosmetics Rule 1945

• Various Schedules Under Drugs & Cosmetics Act 1940

• The Drugs And Cosmetics Act, 1940 (Amendments)

• Schedule Y – What it Covers And Associated Rules

• Responsibilities of Sponsor, Investigator And Ethics Committee

• Application For Permission Under Form 44, Regulatory Authorities, Fees And Test License

• Appendices Of Schedule Y

DRUG REGULATORY LAWS1940 - Drugs and Cosmetic Act

1985 - Narcotic Drugs and Psychotropic Substances Act

2000 - Ethical Guidelines for Biomedical Research on Human Subjects, ICMR

2001 - Indian GCP Guidelines

2002 - Amendment to Drugs & Cosmetics Act

2005 - Revised Schedule Y

Future : Guidelines for pre-clinical data for r- DNA vaccines, diagnostics & biologicals,

DBT. Draft Guidelines for Stem Cell Research/ Regulation, ICMR.

THE DRUGS AND COSMETICS ACT, 1940

• An Act to regulate import, manufacture, distribution and sale of drugs and cosmetics.

• Passed by the Indian Parliament.

• It extends to the whole of India

• Both the Act and the Rules came into force from April 1947

DRUGS & COSMETICS RULE 1945

• 168 Rules has been divided in to Parts from I –XIX as per the different subjects pertaining to

• Schedule (organized plan for matters to be attended to) are from A to Y

• Act: a law or formal decision made by a parliament or other group of elected law-makers

• Rule: an accepted principle or instruction that states the way things are or should be done, and tells you what you are allowed or are not allowed to do

VARIOUS SCHEDULES UNDER DRUGS & COSMETICS ACT 1940

Schedules A-Y

• Schedule A – Applications and Licenses

• Schedule B – Fees for Analysis

• Schedule C – Biological, Immunological and parenteral products

• Schedule D – Exemptions

• Schedule E – Poisons

• Schedule F – Vaccines, sera etc

• Schedule G – Under medical supervision - Caution

• Schedule H – Prescription drugs

• Schedule J – Name of the diseases/ailments which a drug may not purport to prevent or cure by means of claims made on the label of the container.

• Schedule K – Generics

• Schedule M – GMP

• Schedule N – Requirements for Running Pharmacy

• Schedule O – Standards for Disinfectant fluids

• Schedule P – Packaging and Shelf life

• Schedule Q – Colours used in drugs

• Schedule R – Labeling

• Schedule S – Cosmetics

• Schedule T – Factory Premises

• Schedule U – Manufacturing records

• Schedule V – Standards for patent and proprietary drugs

• Schedule X – Control Measures taken for Psychotropic Drugs

• Schedule Y – Requirements and guidelines on clinical trials for import and manufacture of drugs

THE DRUGS AND COSMETICS ACT, 1940 (AMMENDMENTS)

• The Drugs (Amendment) Act, 1955,



• Drugs and Cosmetics (Amendments) Act, 1964,

• The Drugs and Cosmetics (Amendments) Act, 1972,

THE DRUGS AND COSMETICS ACT, 1940 (AMMENDMENTS)



• The Drugs and Cosmetics (Amendments) Act, 1995

SCHEDULE - Y

SCHEDULE - Y

REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL

TRIALS

Schedule Y

UTILITY

RIGHTS SAFETY WELL BEING

OF HUMAN SUBJECTS

SCOPE

NEW DRUG DEVELOPMENT

PROCESS IN INDIA

• In Drugs & Cosmetics Rules (Part X-A) : 122A-122E

122-A Application for permission to import new drug

122-B Application for approval to manufacture new drug other than the drugs classifiable under Schedules C (biologics, etc)

122-C Deleted

122-D Permission to import or manufacture Fixed Dose combination: Defined FDC

122-DA Application for permission to conduct clinical trials for ND/IND.

122-DAA Definition of Clinical trial

122-E Definition of New Drug

122-DAA

Definition of Clinical trial

“Clinical trial” means a systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and / or efficacy of the new drug.”

122 - E

NEW DRUG

- Not been used in the country under labeling conditions

- Approved but now proposed to be marketed with modified or new claims – indications, dosage, dosage form, route of administration

- FDC, individually approved, to be combined for the first time in a fixed ratio or if ratio is changed

• Vaccines are new drugs unless otherwise certified

• Considered new drug for 4 years or inclusion in IP

INVESTIGATIONAL NEW DRUG

New chemical entity or a product having therapeutic indication but which has never been earlier tested on human beings

RESPONSIBILITIES OF SPONSOR, INVESTIGATOR AND ETHICS

COMMITTEE

RESPONSIBILITIES OF THE SPONSOR

• Implementing and maintaining quality assurance systems - Good Clinical Practice (GCP) Guidelines issued by CDSCO, INDIA

• Sponsors are required to submit a status report on the clinical trial to the Licensing Authority at the prescribed periodicity (annual).


• In case of studies prematurely discontinued for any reason including lack of commercial interest in pursuing the new drug application, a summary report should be submitted within 3 months.

• The summary report should provide a brief description of the study, the number of patients exposed to the drug, dose and duration of exposure, details of adverse drug reactions and the reason for discontinuation of the study or non-pursuit of the new drug application


• Any Unexpected Serious Adverse Event (SAE)(as defined in GCP Guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study

DEFINITION SAE / SADR / AE / ADR

• SAE / SADR: An adverse event / adverse reaction associated with death, in patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect or is otherwise life threatening

• Adverse Event (AE) : any untoward medical occurrence (including a symptom / disease or an abnormal lab finding) during treatment with a pharmaceutical product in a patient or a human volunteer that does not necessarily have a relationship with the treatment being given.

DEFINITION SAE / SADR / AE / ADR

• Adverse Drug Reaction (ADR) :

Approved product: Noxious / unintended response at doses normally used or tested in humans

Unapproved product: Noxious / unintended response at any doseThere is reasonable possibility that the adverse event is related with medicinal product studied

RESPONSIBILITIES OF INVESTIGATOR

• Responsible for the conduct of the trial according to the protocoland the GCP Guidelines and also for compliance.

• Standard operating procedures are required to be documentedby the investigators for the tasks performed by them.

• Ensure that adequate medical care is provided to the participantfor any adverse events.

• Report all serious and unexpected adverse events to the Sponsorwithin 24 hours and to the Ethics Committee that accordedapproval to the study protocol within 7 working days of theiroccurrence.

RESPONSIBILITIES OF ETHICS COMMITTEE

• Safeguard the rights, safety and well being of all trial subjects.

• Particular care to protect the rights, safety and well being of all vulnerable subjects

• Obtain ‘Standard Operating Procedures’ and maintain a record

• Ongoing review based on periodic study progress reports

• In case an ethics committee revokes its approval it must record the reasons for doing so and at once communicate such a decision to the Investigator as well as to the Licensing Authority.

APPLICATION FOR PERMISSION UNDER FORM 44, REGULATORY AUTHORITIES, FEES AND TEST

LICENCE

Ministry of Chem & Fertilizers

NPPANational Pharmaceutical

Pricing Authority

Pricing Regulations

Ministry of Sci & Tech

DBTDepartment of Biotechnology

Ministry of Enviro

Additional Secretary

State Drug Regulatory Authority : FDA

GEACGenetic Engineering Approval Committee

DCGIDrug Controller General of India

DGHSDirector General of

Health Services

Health Secretary

Ministry of Health

CDL/CDTLGov. Drug Testing

Laboratories

REGULATORY AUTHORITIES

FEES

• Import ff/ Mfg ff/ Import bulk + Mfg ff of new drug = Rs 50,000/-

• Application by same applicant, = Rs 15,000/-for modified dosage form or with new claim

• Secondary applicants after 1 year of approval = Rs 15,000/-

• Import / Mfg FDC = Rs 15,000/-

• Conduct Clinical trial with ND/IND– Phase I = Rs 50,000/-

– Phase II = Rs 25,000/-

– Phase III = Rs 25,000/-

No separate fee to be paid along with application for import / mfg based on successfulcompletion

APPLICATION IN FORM 44FORM 44

(See Rules 122A, 122B, 122D and 122DA)Application for grant of permission to import or manufacture a New Drug or to undertake

clinical trial

I/We..……….. of ………..hereby apply for grant of permission for import and / or clinical trial or for approval to manufacture of a new drug or fixed dose combination or subsequent permission of already approved new drug. The necessary information / data is given below :

1. Particulars of New Drug :1. Name of the drug : 2. Dosage Form : 3. Composition of the formulation : 4. Test specifications :

Active ingredients : Inactive ingredients :

5. Pharmacological classification of the drug : 6. Indications for which proposed to be used :7. Manufacturer of the raw material :8. Patent status :

FORM 44 Contd….2. Data submitted along with the application

A Permission to market new drug

1. Chemical and Pharmaceutical information2. Animal Pharmacology 3. Animal Toxicology 4. Human / Clinical Pharmacology5. Exploratory Clinical Trials6. Confirmatory Clinical Trials 7. Bioavailability / dissolution and stability data 8. Regulatory status in other countries 9. Marketing information :

(a) Proposed product monograph(b) Drafts of labels and cartons

10. Application for test licence :

FORM 44 Contd….

B Subsequent approval / permission for manufacture of already approved new drug

a) Formulation :a) Bioavailability / bioequivalenceb) Name of the investigator / centrec) Source of raw materials and stability

b) Raw Material• Manufacturing Method• QC parameters, specifications, stability• Animal toxicity

C Approval / permission for FDC

1. Justification2. P’cokinetic / P’codynamic data 3. Any other data

FORM 44 Contd……

D Subsequent approval or approval for new indication – new dosage form :

• Number and date of Approval already granted• Justification• Data on safety, efficacy and quality

A total fee of Rs………………… has been credited to the Government under the Head of Account …… (receipt enclosed)

SignatureDesignationDate

IMPORTANT CONSIDERATIONS - 1

HUMAN CLINICAL PHARMACOLOGY :-

(a) Phase I (Human Pharmacology) – Safety and Tolerability with theinitial administration of IND – MTD, Kinetics and Dynamics

(b) Phase II (Therapeutic Exploratory Trials) – Effectiveness for aparticular indication, small group

(c) Phase III (Therapeutic Confirmatory Trials) – Therapeutic benefitin large number of patients

(d) Phase IV (Post Marketing Trials) – Related to approved indication

IMPORTANT CONSIDERATIONSHUMAN CLINICAL PHARMACOLOGY :-(a) for new drug substances discovered in India : Data from Phase I(b) for new drug substances discovered in countries other than India :

Phase I data generated outside India, permission may be granted forPhase II trials and subsequently Phase III trials concurrently with otherglobal trials

(c) Application for permission to initiate specific phase of clinical trialshould also accompany Investigator’s brochure, proposed protocol, caserecord form, study subject’s informed consent document(s)investigator’s undertaking and ethics committee clearance, if available

(d) Sample size depends on type of study(e) EC application can be in parallel to DCGI application(f) Amendments notified to DCGI and EC within 30 days and approval

obtained


PSURNew drugs should be closely monitored for their clinical safety; submission of

Periodic Safety Update Reports (PSURs) in order to-

• report all the relevant new information (patient exposure)• summarize the market authorization status in different countries

and any significant variations related to safety; and• indicate whether changes should be made to product information

PSURs shall be submitted every 6 months for the first two years after approval

For subsequent two years – the PSURs need to be submitted annually

PSURs due for a period must be submitted within 30 calendar days of the last day of the reporting period.

IMPORTANT CONSIDERATIONS

PSUR Structure:-

(a) A title page stating: Periodic safety update report for the product, applicant’s name, period covered by the report, date of approval of new drug, date of marketing of new drug and date of reporting;

(b) Introduction,(c) Current worldwide market authorization status,(d) Update of actions taken for safety reasons,(e) Changes to reference safety information,(f) Estimated patient exposure,(g) Presentation of individual case histories,(h) Studies,(i) Other information,(j) Overall safety evaluation,(k) Conclusion,(l) Appendix providing material relating to indications, dosing, pharmacology and

other related information.


DRAFTS OF LABEL AND CARTONS :-

• Should comply with Rules 96 of the D&C Rules, 1945

• After Approval no changes in the package insert shall be effectedwithout such changes being approved


BE / BA

(i) For drugs approved elsewhere in the world and absorbed systemically,bioequivalence with the reference formulation should be carriedout.

(ii) Evaluation of the effect of food

(iii) Dissolution and bioavailability data to be submitted

(iv) All bioavailability and bioequivalence studies should be conductedaccording to the Guidelines for Bioavailability and Bioequivalencestudies as prescribed (ICMR guidelines)

APPENDICES OF SCHEDULE Y

APPENDIX I – DATA SUBMITTED WITH APPLICATION FOR PERMISSION TO MARKET A NEW DRUG

1. INTRODUCTION

A brief description of the drug and the therapeutic class to which it belongs.

2. CHEMICAL AND PHARMACEUTICAL INFORMATION.

2.1. Chemical name, code name or number, if any, non-proprietary or generic

name, if any, structure, physio-chemical proportion.

2.2. Dosage form and its composition.

2.3. Specifications of active and inactive ingredients.

2.4. Tests for identification of the active ingredient and method of its assay.

2.5. Outline of the method of manufacture of the active ingredient.

2.6. Stability data

3. ANIMAL PHARMACOLOGY3.1. Summary

3.2. Specific pharmacological actions.

3.3. General pharmacological actions.

3.4. Pharmacokinetics, absorption, distribution, metabolism, excretion.


4. ANIMAL TOXICOLOGY (See Appendix III and IV)

4.1. Summary

4.2. Acute Toxicity

4.3. Long Term Toxicity

4.4. Reproduction Studies.

4.5. Local Toxicity

4.6. Mutagenicity and Carcinogenicity.

5. HUMAN/CLINICAL PHARMACOLOGY (PHASE I)

5.1. Summary

5.2. Specific Pharmacological effects.

5.3. General Pharmacological effects.

5.4. Pharmacokinetics, absorption, distribution, metabolism, excretion.


6. EXPLANATORY CLINICAL TRIALS (PHASE II)

6.1. Summary

6.2. Investigator-wise reports.

7. CONFIRMATORY CLINICAL TRIALS (PHASE III)

7.1. Summary

7.2. Investigator-wise reports

8. SPECIAL STUDIES

8.1. Summary

8.2. Bioavailability and dissolution studies.

8.3. Investigator-wise reports.


9. REGULATORY STATUS IN OTHER COUNTRIES9.1. Countries where –

(a) Marketed

(b) Approved.

(c) Under trial, with phase.

(d) Withdrawn, if any, with reasons.

9.2. Restrictions on use, if any, in countries where marketed/

9.3. Free sale certificate from country of origin.

10. MARKETING INFORMATION

10.1. Proposed product monograph

10.2. Drafts of labels and cartons.

10.3. Sample of pure drug substance, with testing protocol.

APPENDIX IA – DATA SUBMITTED GRANT OF PERMISSION TO IMPORT MANUFACTURE AN ALREADY

APPROVED NEW DRUG

1. INTRODUCTION

A brief description of the drug and the therapeutic class.

2. CHEMICAL AND PHARMACEUTICAL INFORMATION.

2.1. Chemical name, code name or number, if any, non-proprietary or generic

name, if any, structure, physio-chemical properties.

2.2. Dosage from its composition

2.3. Test specifications.

(a) Active ingredients.

(b) Inactive ingredients

2.4. Tests for identification of the active ingredients and method of its assay.

2.5. Outline of the method of manufacture of active ingredients.

2.6. Stability data.

APPENDIX IA – DATA SUBMITTED GRANT OF PERMISSION TO IMPORT MANUFACTURE AN ALREADY

APPROVED NEW DRUG

3. MARKETING INFORMATION3.1 Proposed package insert/promotional literature

3.2 Draft specimen of the label and carton.

4. SPECIAL STUDIES CONDUCTED WITH APPROVAL OF LICENSING AUTHORITY

4.1. Bioavailability/Bioequivalance and comparative Dissolution Studies, for oral

dosage form,

4.2. Sub-acute animal toxicity studies for intravenous infusions and injectables.

APPENDIX II – FORMAT OF STUDY REPORT1. Title Page: Protocol code, name of the investigational product tested, development phase,

indication studied, a brief description of the trial design, the start and end date of patient accrual, names of the Sponsor and the participating Institutes (Investigators).

2. Study Synopsis (1 to 2 pages): summarize important conclusions

3. Statement of compliance with the ‘Guidelines for Clinical Trials on Pharmaceutical Products in India – GCP Guidelines’ issued by CDSCO.

4. List of Abbreviations and Definitions

5. Table of contents

6. Ethics Committee: Study conducted in accordance with the ethical principles of Declaration of Helsinki. A detailed description of the Ethics Committee constitution and date(s) of approvals of trial documents for each of the participating sites should be provided. A declaration should state that EC notifications as per Good Clinical Practice Guidelines issued by Central Drugs Standard Control Organization and Ethical Guidelines for Biomedical Research on Human Subjects, issued by Indian Council of Medical Research have been followed.

APPENDIX II – FORMAT OF STUDY REPORT

7. Study Team: Administrative structure of the study (Investigators, site staff, Sponsor/ designates, Central laboratory etc.).

8. Introduction: Description of the product development rationale

9. Study Objective: Overall purpose of the study, primary and secondary objectives

10. Investigational Plan: Trial design, the Subject selection criteria, the treatment procedures, blinding / randomization techniques if any, allowed/ disallowed concomitant treatment, the efficacy and safety criteria assessed, the data quality assurance procedures and the statistical methods planned for the analysis of the data obtained.

11. Trial Subjects : Enumerate the patients screened, randomised, and prematurely discontinued. State reasons for premature discontinuation of therapy in each applicable case.

12. Efficacy evaluation : Results

APPENDIX II – FORMAT OF STUDY REPORT13. Safety Evaluation : Complete list

13.1 all serious adverse events, whether expected or unexpected and 13.2 unexpected adverse events whether serious or not

14. Discussion and overall Conclusion

15. List of References

16. Appendicesa. Protocol and amendmentsb. Specimen of Case Record Formc. Investigators’ name with contact addresses, phone, emaild. Patient data listingse. List of trial participants treated with investigational productf. Discontinued participantsg. Protocol deviationsh. CRFs of cases involving death / life threatening AE casesi. Publications from the trialj. Important publications referenced in the studyk. Audit certificate, if availablel. Investigator’s certificate on accuracy of the study

APPENDIX III – ANIMAL TOXICOLOGY

•Toxicity studies to comply with GLP

•Systemic Toxicity Studies

Single dose (2 rodent species); 2g/kg or 10 times dose in humans – 14 days observation; Minimum lethal dose / Maximum tolerated dose

Repeated dose (2 mammalian species, 1 non-rodent); administration for 7 days

•Dose Ranging Study : Identify target organ and establish MTD

•Male Fertility Study

•Female Reproduction and Developmental Toxicity Study

APPENDIX III – ANIMAL TOXICOLOGY

•Perinatal study

•Local toxicity – Dermal, vaginal, rectal, ocular, inhalation

•Allergenicity / hypersensitivity

•Genotoxicity

•Carcinogenicity

APPENDIX IV – ANIMAL PHARMACOLOGY

• Cardiovascular System

• Central Nervous System

• Respiratory System

• Follow up and Supplemental Safety Pharmacology

APPENDIX V – INFORMED CONSENTEssential Elements:

Study involves research and its purpose

Expected duration of participation

Description of the procedures

Description of foreseeable risks or discomforts

Description of any benefits to subject / mankind

Alternative procedures or therapies

Statement describing confidentiality of records

Trial treatment schedule(s)

Compensation and/or treatment(s) in the event of a trial-related injury

Whom to contact, rights of Subjects and in the event of any injury

Anticipated prorated payment, if any, to the Subject for participating in the

trial

Subject's responsibilities

APPENDIX V – INFORMED CONSENT Voluntary participation, no penalty or loss of benefits to which the Subject is

otherwise entitled

Additional elements, which may be required

Foreseeable circumstances under which the Subject's Participation may be

terminated without the Subject's consent

Additional costs to the Subject

Consequences to withdraw from the research and procedures for orderly

termination

Notification in a timely manner if significant new findings develop which may

affect the Subject's willingness to continue participation

Particular treatment or procedure may involve risks to the Subject (or to the

embryo or fetus, if the Subject is or may become pregnant), which are

currently unforeseeable

Approximate number of Subjects enrolled in the study

APPENDIX VI – FIXED DOSE COMBINATIONS

Fixed Dose Combinations refer to products containing one or more active ingredients used for a particular indication(s).


GROUP 1 : One or more of the active ingredients is a new drug.

• Marketing data will be similar to data required for any new drug (including clinical trials)

APPENDIX VI – FIXED DOSE COMBINATIONS cont’d

GROUP 2 : Active ingredients already approved/marketed individually,

combined for the first time, for a particular claim and where the ingredients are likely to have significant interaction of a pharmacodynamic or pharmacokinetic nature

If Marketed abroad :• Clinical trial reports of other countries• Regulatory status in other countries

If not Marketed abroad :• Chemical and pharmaceutical data will be submitted - chemical and

pharmaceutical data, stability of the proposed dosage form • Clinical trials (pharmacological, toxicological and clinical data on the individual

ingredients along with the rationale for combining them in the proposed ratio. Acute toxicity data (LD 50) and pharmacological data should be submitted on the individual ingredients as well as their combination in the proposed ratio.


GROUP 3 : Already marketed, but in which it is proposed either to change the ratio of active ingredients or to make a new therapeutic claim. For such FDCs, the appropriate rationale including published reports (if any) should be submitted to obtain marketing permission. Permission will be granted depending upon the nature of the claim and data submitted.


GROUP 4 : Individual active ingredients (or drugs from the same class) have been widely used in a particular indication(s) for years, their concomitant use is often necessary and no claim is proposed to be made other than convenience. It will have to be demonstrated that the proposed dosage form is stable and the ingredients are unlikely to have significant interaction of a pharmacodynamic or pharmacokinetic nature.

No additional animal or human data are generally required for these FDCs, and marketing permission may be granted if the FDC has an acceptable rationale.

APPENDIX VII – UNDERTAKING BY INVESTIGATOR

1. Full name, address, title

2. Name / address of medical college, hospital or other facility where the clinical trial will be conducted. Education, training & experience, qualification and MCR (Medical Council Registration) number

3. Name / address of clinical laboratory facilities

4. Name / address of the Ethics Committee

5. Names of other members of the research team

6. Protocol Title and Study number (if any) of the clinical trial to be conducted by the Investigator.

APPENDIX VIII – ETHICS COMMITTEE At least seven members

Should appoint Chairperson (who is from outside the institution) and a

Member Secretary.

Quorum at least 5 members with the following representations:

1. basic medical scientists (preferably one pharmacologist).

2. clinicians

3. legal expert

4. social scientist / representative of NGO voluntary agency /philosopher

/ ethicist / theologian or a similar person

5. lay person from the community.

Must include at least one non-scientific member and at least one member who

is independent of the institution / trial site.

Appropriate gender representation on the Ethics Committee.

EC members who are independent of trial and sponsor should vote / provide

opinion in matters related to the study.

APPENDIX IX – STABILITY TESTING OF NEW DRUGS

• Evidence on how the quality of a drug substance or formulation varies with time under the influence of various environmental factors

• To establish shelf life for the formulation / recommended storage

• Validated stability-indicating analytical procedures

• Stress testing of the drug substance on single batch to identify degradation products

• Photostability on at least one primary batch of the drug substance as well as the formulation,

Pilot Batch : 1/10th of commercial / production batch

Primary Batch : Batch used in stability study for registration / establish shelf life.

1. Title Page a. Full title b. Protocol / Study number, and protocol version number with datec. The IND name/number of the investigational drug d. Complete name and address of the Sponsor and CROe. List of the Investigators, institutional affiliations and site locationsf. Name(s) of clinical laboratories and/or facilities participating in study.

2. Table of Contents

3. Background and IntroductionPreclinical experienceClinical experience

4. Study Rationale

5. Study Objective(s)

6. Study Design

APPENDIX X – PROPOSED PROTOCOL

7. Study Population

8. Subject Eligibilitya. Inclusion Criteriab. Exclusion Criteria

9. Study Assessments

10. Study Conduct

11. Discontinued Subjects

12. Study Treatment (Dosing Schedule, Drug supplies, administration, dose modification, possible drug interactions, concomitant therapy, blinding / unblinding procedures)



13. Adverse Events

14. Ethical Considerations (Risk/benefit assessment, EC review and communications, Informed consent process, Statement of Subject confidentiality including ownership of data and coding procedures)

15. Study Monitoring and Supervision

16. Investigational Product Management

17. Data Analysis

18. Undertaking by the Investigator

19. Appendices (Study synopsis, patient information sheet, informed consent form, CRF, other data collection forms, a summary of relevant pre-clinical safety information and any other documents referenced)

APPENDIX XI – DATA FOR REPORTING SAE

1. Patient Details

Initials & other relevant identifier (hospital/OPD record number etc.)

Gender Age and/or date of birth Weight Height

2. Suspected Drug(s)

Generic name of the drug

Indication(s) for which suspect drug was prescribed or tested

Dosage form and strength

Daily dose and regimen (specify units - e.g., mg, ml, mg/kg)

Route of administration

Starting date and time of day

Stopping date and time, or duration of treatment

3. Other Treatment(s)

Provide the same information for concomitant drugs (including non prescription/OTC drugs) and non-drug therapies, as for the suspected drug(s).

4. Details of Suspected Adverse Drug Reaction(s)

Full description of reaction(s) including body site and severity, as well as the criterion (or criteria) for regarding the report as serious. In addition to a description of the reported signs and symptoms, whenever possible, describe a specific diagnosis for the reaction.

Start date (and time) of onset of reaction Stop date (and time) or duration of reaction De-challenge and re-challenge information Setting (e.g., hospital, out-patient clinic, home, nursing

home)

5. Outcome

Information on recovery and any sequelae; results of specific tests and/or treatment that may have been conducted

For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; Any post-mortem findings.

6. Details about the Investigator

Name Address Telephone number Profession (specialty) Date of reporting the event to Licensing Authority: Date of reporting the event to Ethics Committee overseeing

the site: Signature of the Investigator

UNATTENDED AREAS

Regulations for :1. Biologics :

» Vaccines

» Blood products

» Tissue

» Cellular/Gene therapy

2. Herbals

3. Medical devices

4. Pharmacovigilance

5. Electronic records

THANK YOU !!!

07-10-2010+Schedule+Y_+SA.pdf

Documents

Transcript of 07-10-2010+Schedule+Y_+SA.pdf