Animal Toxicology studies as per the CDSCO Guidance
General Principles: Toxicity studies should comply with the norms of Good Laboratory Practices (GLP). Briefly, these studies should be performed by suitably trained and…
Read more →Requirements for drug approval with new claims
In case a drug already approved by the Central Licencing Authority for certain claims, which is now proposed to be clinically tried or marketed…
Read more →Accelerated approval process
In such case, the approval of the new drug may be based on data generated in clinical trial where surrogate endpoint shall be considered…
Read more →Requirements and guidelines for permission to import or manufacture of new drug
Application for permission to import or manufacture new drug for sale or to undertake clinical trials under these Rules shall be made to the…
Read more →Import of New drug/Investigational drug for clinical trials
Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or Any…
Read more →Regulation on Medical Device in India (Medical devices rules, 2017)
Ministry of health and family welfare on 31st January 2017 published the guidance regarding Medical devices. Regulation of Medical Device Classification of Medical devices:…
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