| 1 |
Revised Export NOC Guidance document for Manufacture of Unapproved / Approved New Drugs along with revised Annexures |
2025-May-07 |
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673 KB |
| 2 |
Inviting comments on Revised Guidelines on Similar Biologics- Regulatory requirements for Marketing Authorization in India, 2025 drafted by CDSCO |
2025-May-06 |
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1002 KB |
| 3 |
Public Notice on PRO Schedule |
2025-Apr-30 |
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349 KB |
| 4 |
Examination of 2nd assessment report of Prof. Kokate Committee by Drugs Technical Advisory Board (DTAB) in its meeting dated 26.09.2022 |
2025-Apr-11 |
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3102 KB |
| 5 |
Manufacturing and marketing of unapproved FDCs regarding |
2025-Apr-11 |
|
223 KB |
| 6 |
Provision for auto-generated Market Standing Certificate and Non-Conviction Certificate for licenced medical device |
2025-Apr-09 |
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307 KB |
| 7 |
Provision for system auto-generated Neutral code by the manufacturer for the export purpose under Medical Devices Rules, 2017 |
2025-Apr-09 |
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338 KB |
| 8 |
Provision for system auto-generated Neutral Code by the manufacturer for the export purpose under Medical Devices Rules 2017 |
2025-Apr-09 |
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404 KB |
| 9 |
Prohibits to import manufacture sale and distribution and use in any food producing animal rearing system of drug formulations containing Chloramphenicol or Nitrofurans drug with immediate effect |
2025-Apr-02 |
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490 KB |
| 10 |
Draft risk based classification list Cardiovascular and Neurological dated 01 04 2025 for stakeholder comments |
2025-Apr-01 |
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1014 KB |
