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. To enhance the communication aspects, CDSCO should ensure that the industry representatives, and other stakeholders have easy and open access to all the relevant regulatory information and are educated about the drug regulatory requirements, process involved in new drug development. 4. Similarly, CDSCO meetings including Pre-submission/ Post–submission/SEC meetings should be held as per the lai ...

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.