Schedule y


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Schedule y

  1. 1. By D. Saidulu
  2. 2. 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
  3. 3. Application for permission Clinical Trial Studies in Specific Population Post Marketing Surveillance Special Studies : BA/BE studies
  4. 4. 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
  5. 5. 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
  6. 6.  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
  7. 7.  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
  8. 8.  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