ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

4^th October, 2021

TMDA GRANTS ORPHAN MEDICINE DESIGNATION STATUS FOR COMFORA FOR THE TREATMENT OF BLADDER PAIN AND DISCOMFORT ASSOCIATED WITH INTERSTITIAL CYSTITIS

1. Tanzania Medicines and Medical Devices Authority (TMDA) would like to inform its esteemed stakeholders and the general public that pursuant to subregulation 6(2) of the Tanzania Medicines and Medical Devices (Orphan Medicines) Regulations 2018, it has granted an orphan medicines designation status for Pentosan Polysulphate Sodium 100mg capsule (Comfora). The medicine is indicated for the treatment of bladder pain and discomfort associated with interstitial cystitis.
2. Orphan medicine designation is granted by the Authority to medicinal products intended for use in a life-threatening, seriously debilitating or chronic disease that impact less than 25,000 people in Tanzania for which no satisfactory method of diagnosis, prevention or treatment has been registered or, if such method exists, the medicinal product would be of significant benefit to those affected by that disease.
3. Orphan medicine designation serve as a stimulus for the development of medicines for rare diseases through several incentives including fast track reviews of applications and waiver of fees associated with marketing authorization.
4. Furthermore, the Authority would like to highlight to the public that, granting of an orphan medicine designation does not alter the standard regulatory requirements for establishing quality, safety and efficacy required for issuing marketing authorization to the designated products.
5. The register for the List of Products Designated as Orphan Medicinal Products can be accessed byclicking here

   List of Products Designated as Orphan Medicinal Products

   Ref No.	Brand name	Active Ingredient	Dosage form and strength	Indication	Name and address of applicant	Name and address of manufacturer	Pack size	Designation date
   TRC0020/HM/0307	COMFORA	Pentosan Polysulfate Sodium	Hard Gelatin Capsules of 100 mg	Relief of bladder pain or discomfort associated with interstitial cystitis	Swati Spentose Pvt. Limited, 114, Marine Chambers, 11 New Lines Mumbai- 400012, India.	Steril-Gene Lifesciences (P) Limited, 45, Main Road Mangalam, Villanur Commune, Puducherry 605110, India.	HDPE Bottle of 90's	August, 2021

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