- Introduction:
A brief description of the drug and the therapeutic class to which it belongs. - Chemical and pharmaceutical information, Animal pharmacological and toxicological data, Clinical trial data:
- Published reports of Pharmacokinetic and Pharmacodynamics studies carried out in healthy subjects or patients demonstrating safety and tolerability of the molecule.
- Regulatory status in other countries
- Countries where the drug is,—
- Marketed.
- Approved.
- Approved as Investigational New Drug.
- Withdrawn, if any, with reasons.
- Restrictions on use, if any, in countries where marketed or approved.
- Free sale certificate or certificate of analysis, as appropriate.
- Countries where the drug is,—
- Prescribing information of the new drug in case the drug is approved for marketing in the country or other country.
- Undertaking by the Investigator in original duly signed on a company letterhead as per Table 4 of the Third Schedule.
- Copy of registration certificate issued by Central Licencing Authority.
- Sponsor’s Authorisation letter duly signed by the Authorised Signatory on company’s letterhead.
- The study protocols, informed consent form or patient information sheet along with audio-visual recording system as per requirements of Second Schedule.
- Copy of approval of protocol from the Ethics committee, if available. Copy of registration of the Ethics Committee under rule 8 from the Central Licencing Authority.
- The study synopsis.
- Undertaking letter from the sponsor stating that complete medical management in accordance with rule 40 and an undertaking letter from the sponsor stating that compensation in case of study relate injury or death shall be provided in accordance with rule 39.
- Certificate of Analysis (COA) of representative batches (both Test and Reference formulations) to be used in the BE study along with dissolution profile in case Oral Solid dosage forms.
- For multiple dose BE study adequate supporting safety data and Pharamcokinetics or Pharmacodynamics should be submitted covering the duration of period for which the study has to be conducted. For all injectable, the sub-acute toxicity should be submitted on the Test product of the sponsor, studied in at least two species for minimum 14 days. If regulatory guidance is available provide a copy of the same.
- For conducting Bio-Equivalence studies with reference to Cytotoxic drugs, Hormonal preparations, Narcotic and Psychotropic substances and radioactive substances in Healthy Human subjects a Scientific justification with special emphasis on safety of subjects with a proper risk mitigation strategy should be submitted. If regulatory guidance is available provide a copy of the same.
- For conducting Bio-Equivalence studies with reference to cytotoxic drugs, Hormonal preparations, Narcotic and Psychotropic substances and radioactive substances in Patients a scientific justification with special emphasis on Safety with a proper Risk Mitigation Strategy should be submitted.
