Licensing and registration of food business
Document required for registration of bio availability and bioequivalence centre
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 with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration or novel drug delivery system (NDDS), the requirements of data and information […]
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 rather than using standard outcome measures such as survival or disease progression, which are reasonably likely to predict clinical benefit, or a clinical endpoint. These should be measurable earlier than irreversible […]
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 person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or The application under sub-rule (2) shall be accompanied by […]
Import of Medical Devices to Inida
The CDSCO has provided the guidance for importing medical device in India. It being stated in the guidance that: Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import […]
Navigating the Regulatory Landscape: Essential Documentation for Medical Device Licenses in India
Introduction: In the dynamic world of healthcare, the import, manufacture, and distribution of medical devices are subject to stringent regulations to ensure the safety and efficacy of these products. In India, the Central Drugs Standard Control Organization (CDSCO) has outlined specific requirements for the issuance of licenses for medical devices. This blog explores the crucial […]
Registration of Bioavailability and Bioequivalence study centre
Application for registration of bioavailability and bioequivalence study centre Application for registration of any bioavailability and bioequivalence study centre with the Central Licencing Authority shall be made to the said authority in Form CT-08. The application under sub-rule (1) shall be accompanied by a fee as specified in the Sixth Schedule and such other information […]
Application for conducting Bioavailability or Bioequivalence study
Any person or institution or organisation which intends to conduct bioavailability or bioequivalence study of a new drug or an investigational new drug in human subjects shall obtain permission for conducting bioavailability or bioequivalence study from the Central Licencing Authority by making an application in Form CT-05. The Central Licencing Authority may, after scrutiny of […]
