Pharmacovigilance System Master File for India
The Pharmacovigilance guidance document for Marketing Authorization Holders of Pharmaceutical Products stated following thing regarding Pharmacovigilance System Master file PSMF. Content of PSMF Module…
Read more →Pharmacovigilance System of India
Pharmacovigilance system in India The guidance is being provided by the Indian Pharmacopoeia Commission. The Pharmacovigilance Guidance Document for Marketing Authorization Holders for Pharmaceutical…
Read more →General Definitions according to CDSCO guidance
General Definitions according to CDSCO guidanceAyurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or…
Read more →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…
Read more →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…
Read more →Regulation for Conducting trial for New Drug in India
Definition: ) “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic…
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