Here is a list of some of the
necessary documents for new drug approval in Nepal:
Drug Master File (DMF): A
document containing detailed information about the drug, including its
composition, manufacturing process, and quality control measures.
Clinical Trial Protocol: A
document outlining the plan for the clinical trial, including the study design,
objectives, inclusion/exclusion criteria, and methods for data collection and
analysis.
Investigator's Brochure: A
document containing information about the drug being studied, including its
proposed use, mechanism of action, and any relevant safety information.
Informed Consent Form: A document
that explains the details of the clinical trial to potential participants and
obtains their consent to participate.
Clinical Study Report: A document
summarizing the results of the clinical trial, including the study design,
results, and any adverse events that occurred.
Statistical Analysis Plan: A
document outlining the statistical methods to be used for data analysis in the
clinical trial.
Case Report Forms: Forms used to
record data from the clinical trial, including patient demographics, medical
history, and study results.
Monitoring Plan: A document
outlining the plan for monitoring the clinical trial to ensure that it is
conducted in accordance with good clinical practices and the protocol.
Quality Assurance Plan: A
document outlining the quality control measures in place to ensure the
integrity and reliability of the data generated during the clinical trial.
Marketing Authorization
Application: A document submitted to the regulatory authority requesting
approval to market the drug in Nepal.
This is just a general list of
documents that may be required for new drug approval in Nepal. The specific
documents needed may vary depending on the specific drug being studied and the
regulatory requirements of Nepal.