Data elements for reporting serious adverse events occurring in a clinical trial or bio availability or bioequivalence study
Data to be submitted along with application to conduct clinical trial or import or manufacture of a Phytopharmaceutical drug in the country (India)
Data generated by Applicant:
Data required to be submitted by an applicant forconduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength
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 […]
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 Central Licencing Authority accompanied with following data in accordance with the Table 1 or Table 2 or Table 3 or Table 4 of the Second Schedule as the case may be, […]
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 […]
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: Classification of medical devices.— (1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in […]
Regulatory Guidelines for Labelling and Quality Assurance of Medical Devices in India
Introduction: In India, the Central Drugs Standard Control Organization, under the Ministry of Health and Family Welfare, has established comprehensive regulations for the labelling and quality assurance of medical devices. These guidelines aim to ensure the safety, identification, and proper usage of medical devices in the market. The following blog outlines key points from the […]
Regulatory Framework for Clinical Investigations of Medical Devices in India
Introduction: Clinical investigations play a crucial role in the development and evaluation of medical devices, ensuring their safety and efficacy before they reach the market. In India, the regulatory framework for conducting clinical investigations of investigational medical devices is outlined in detailed rules. This blog explores key aspects of these rules, shedding light on the […]
