Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 184

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 184
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 registration.          |

| ● | Advice to sponsor, invoice   
 final 25% of evaluation fee. |

| ● | For new chemical entity,                                     
 advise drug information centers, forensic laboratories, etc. |

Registration

| ● | Sponsor applies to register                                  
 the product on the Australian Register of Therapeutic Goods. |

| ● | Supply is permitted once            
 the applicable number is allocated. |

The drug’s chemistry, toxicology and clinical use are evaluated using data submitted by the sponsoring company. Most of the evaluations are done within the TGA, but external evaluations can be used. When all the data have been evaluated, the application is considered by the Australian Drug Evaluation Committee (“ADEC”). This committee is a group of doctors appointed by the Minister to advise on the suitability of drugs for marketing in Australia. The TGA takes into consideration the advice received from the ADEC when making a final recommendation. 109 The evaluation process relates to pre-marketing activity, but the TGA is also responsible for drugs after they are marketed. Other activities under the control of the TGA include:

| ● | maintenance of the Australian Register of Therapeutic 
 Goods for the registration and listing of products;   |

| ● | control of drug and device exports from Australia; |

| ● | inspection and licensing of manufacturing premises; |

| ● | post marketing surveillance; |

| ● | adverse drug reaction monitoring; |

| ● | reports were received by the Adverse Drug Reactions 
 Advisory Committee;                                 |

| ● | medical device complaint reporting; |

| ● | drug and device recalls; |

| ● | laboratory testing, sample testing; |

| ● | complaint reporting and follow up; and |

| ● | drug and device advertising controls |

The performance of the TGA is monitored in quarterly performance reports which are reviewed by the Industry/Government Consultative Committee. This committee has membership from the TGA, the Department of Finance, the Department of Industry, Science and Technology, and the peak industry organizations representing the manufacturers of prescription drugs, non-prescription drugs, medical devices and herbal and nutritional products. If the TGA does not meet the statutory timelines in approving a drug, then it forgoes 25% of the evaluation fee as a penalty. The sponsor concerned can also consider the outcome as a “deemed refusal” and appeal to the Administrative Appeals Tribunal for a resolution. For variations to the registration of a drug, the TGA must raise an objection within 45 working days, otherwise the application is deemed to be approved. Pharmaceutical