Upload Essential Documents For Form 44

1 Upload Essential Documents For form 44 Note: 1. Click on the checklist point to Upload document against it. Only PDF Documents with size not more than 10 MB are permitted. 2. All checklist items are mandatory. In case of unavailability of document give proper justification regarding the unavailability of document and also Upload supporting document . 3. Partially saved checklist can be viewed/altered under the Saved Application link available on the Dashboard 4. In case the particular document or information sought in the application is not considered to be applicable or relevant by the applicant.

2 It may be stated so by uploading the justification document for the same. 5. Animal Pharmacology & Toxicology Data to be submitted as per schedule Y Appendix IV & III respectively as per phase of trial & report to be submitted as per appendix II of schedule Y. Module I ADMINSTRATIVE SECTION Comments, if any Tabs for Uploading the document Name of the document Yes No Reason for NA 1. Annexure Sheet 2. Covering Letter 3. Forms and Challans form 44 & Challan Details Form12 & Challan Details a. Justification for Quantity to be imported Annexure A (Export NOC) Details about the Central Lab I.

3 Name and Address II. Certifications of the Lab III. Declaration that the samples would be used for test & analysis purposes only IV. Lab SOP 4. Letter of Authorization from the Sponsor 5. Name and Address of the Sponsor 6. Name & Address of the Regulatory Applicant (filing the application) 7. Rationale for conducting the study in India with the proposed drug and indication 8. Drug Details: i. Name of the Study Drug ii. Dosage form & Strength iii. Therapeutic class iv. Regulatory Status of the Drug in India and Other Countries ( if approved in other countries, please attach approval letters) v.

4 Patent Status (In India) 9. Study Details: A) Phase of the study B) GLOBAL Details: i. Names of the participating countries ii. Regulatory status of the study in the other participating countries (if approved in other countries please attach approval letters) iii. Total Number of patients to be enrolled globally iv. Affidavit declaring that the study has not been discontinued in any country. In case of discontinuation the reasons for such a discontinuation would be communicated v. If Any Clinical trial of the Investigational Product has been Withdrawn/discontinued in any country or rejected/refused by any Regulatory Agency if so details of the same.

5 C) INDIA Details: i. Total Number of patients to be enrolled in India ii. List of Investigators with qualification along with CV and MRC. iii. Undertaking by the sponsor for application of marketing authorization in India after successful completion of clinical trial MODULE II SUMMARIES 10. Executive Summary (as per the prescribed attached format) download 11. Protocol Synopsis 12. Synopsis of the Investigational Drug Product MODULE III CMC DATA 13. Investigational Medicinal Products Dossier (IMPD) [The IMPD Dossier needs to be prepared as per the prescribed format in reference to the Appendix I of Schedule Y] Example of format enclosed download MODULE IV ANIMAL TOXICOLOGY DATA (For detailed requirements see appendix III of schedule Y) 14.

6 A Systemic toxicity studies i. Single dose toxicity ii. Repeated dose toxicity B. Male Fertility Study C. Female Reproduction and Developmental Toxicity Studies D. Local toxicity i. Dermal toxicity ii. Ocular toxicity iii. Inhalation toxicity iv. Vaginal toxicity v. Photo allergy or dermal phototoxicity vi. Rectal tolerance test E. Genotoxicity F. Allergenicity/Hypersensitivity G. Carcinogenicity 15. Name, address of the laboratory / laboratories with accreditation certificate /Authorization certificates for all animal toxicological reports **Refer to the explanation stated below on the requirement of toxicity data specific to the phase of the study MODULE V ANIMAL PHARMACOLOGICAL DATA (For detailed requirements see appendix IV of schedule Y) 15.

7 A Summary B. Specific pharmacological actions C. General pharmacological actions D. Follow-up and Supplemental Safety Pharmacology Studies E. Pharmacokinetics: absorption, distribution; metabolism; Excretion MODULE VI CLINICAL DATA 16. Human / Clinical pharmacology (Phase I) Data i. Summary ii. Specific Pharmacological effects iii. General Pharmacological effects iv. Pharmacokinetics, (Absorption,Distribution,Metabolism,Excr etion) v. Pharmacodynamics/early measurement of drug activity 17. Therapeutic exploratory trials (Phase II) Data i. Summary ii. Study report 18.

8 Therapeutic confirmatory trials (Phase III):- i. Summary ii. Individual study reports with listing of sites and Investigators. 19. Special studies:- i. Summary ii. Bio-availability / Bio-equivalence. Other studies i. Geriatrics ii. Paediatrics iii. pregnant or nursing women MODULE VII TRIAL RELATED Documents 20. Study Protocol (state the Version No. and Date) i. Declaration that as per the protocol, whether the subjects will receive the Standard of Care 21. Patient Information Sheet (PIS) and Informed consent form (ICF) as per revised Appendix V of Schedule Y including the following clauses.

9 A. Statement describing the financial compensation and medical management as under:- i. In the event of an injury occurring to the clinical trial subjects, such subjects shall be provided free medical management as long as required ii. In the event of a trial related injury or death, the sponsor or his representative, whosoever has obtained permission from licensing authority for conduct of clinical study shall provide financial compensation for the injury or death. (B) In serial no. 02 of an Appendix V, the following shall be included : Address of the subject: Qualification: Occupation: Student/Self-employed /service/ Housewife / Other(Please tick as appropriate) Annual income of subject: Name and address of the nominee and his/her relation to the subject (for the purpose of compensation in case of trial related death.)

10 (C)After the name of witness occurring at the end, the following shall be inserted: Copy of the patient information sheet and duly filled ICF shall be handed over to the subject or his/her attendant 22. Undertaking by the Sponsor/Sponsors representative/applicant to the licensing authority to provide medical management and compensation in case of clinical trial related injury or death for which subjects are entitled to compensation as required under rule 122 DAB 23. Declaration regarding financial status of the applicant vis-a-vis medical management and compensation to be paid to the trial participants (in case of injury or death in clinical trial) 24.