Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Sep 252 min read

India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products

India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...

Aug 202 min read

India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)

The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...

Mar 52 min read

India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion

India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...

Jan 21 min read

India CDSCO: Launching of National Single Window System (NSWS) Portal

To address the challenges in the management of medical devices, India's Central Drugs Standard Control Organization (CDSCO) has...

Jul 27, 20221 min read

India CDSCO Guidance: 3 IVD Draft Guidances for Consultation

Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...

Sep 29, 20211 min read

India CDSCO -Guide for Manufacturers/Importers for Registration of Non-Notified Medical Devices

India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and...