Accredited Consultants Pvt. Ltd. Clear policy on regulatory requirements, system and procedures is critical for efficient development and approval of new drug through generation of adequate non-clinical and clinical data and their evaluation in transparent and scientific manner for assessment of safety and effectiveness of the new drug.

(1) "clinical investigation" means the systematic study of an investigation medical device in or on human participants to assess its safety, performance or effectiveness; (m) "clinical investigation plan" means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, w ...

5. Clear policy on regulatory requirements, system and procedures is critical for efficient development and approval of new drug through generation of adequate non-clinical and clinical data and their evaluation in transparent and scientific manner for assessment of safety and effectiveness of the new drug. 6. Such policy will not only enhance the public assurance that any new drug approved for ma ...

3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945. 4. Robust system for evaluation of applications of clinical trial and new drug which contains data of Chemistry, Manufacture, Control ...