facebook tracking

CDSCO

CDSCO Launched Additional Forms on National Single Window System (NSWS) Portal


regulatory illustration
regulatory update icon
Importer & Manufacturer   |   CDSCO
16 January, 2024
Enforcement Date: 16 January, 2024
CDSCO Launched Additional Forms on National Single Window System (NSWS) Portal

On January 16, 2024, the Central Drugs Standard Control Organisation (CDSCO) of India released a notification to all interested parties. The National Single Window System (NSWS) was created by the CDSCO to streamline corporate transactions and provide a single point of contact for all investor approvals. On January 16, 2024, further forms introduced by CDSCO will go "Live" on NSWS.


On January 16, 2024, the Central Drugs Standard Control Organization (CDSCO) of India published a notice for all stakeholders to add the following forms along with the forms mentioned in the previous notice in their application for the National Single Window System (NSWS):- 1. Form CT-10: Request for authority to manufacture new or experimental drugs for use in bioavailability or bioequivalency tests, clinical trials 2. Form CT-12: Request for approval to create a formulation with an unapproved active pharmaceutical ingredient for use in analysis, bioequivalency, clinical trials, or other studies involving bioavailability. 3. Form CT-13: Application for permission to manufacture unapproved active pharmaceutical ingredient for clinical trials, formulation development, analysis, testing, and bioavailability and bioequivalence research. 4. Form CT-16: Request for permission to import new or experimental drugs for testing, analysis, and inspection purposes, as well as for use in bioavailability or bioequivalency studies and clinical trials. 5. Form12: Application for license to import drugs for purpose of examination, test or analysis. All the stakeholders are hereby invited to submit applications for the afore mentioned five activities only through the NSWS site.

Applicable For: Importer & Manufacturer
Reference Number: NA Notification Link

Related Regulatory Updates

Contact us

Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.

Need Help?
Enquire Now
Email (contact@cliniexperts.com)
Reception (+91 1145214546)
Sales (+91 7672005050)

Enquire Now