Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 183

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 183
---
 the E.U. Treaty. Since the regulatory framework for pharmaceutical products in the U.K. covering quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization, commercial sales and distribution of pharmaceutical products is derived from European Union directives and regulations, Brexit could materially impact the future regulatory regime which applies to products and the approval of product candidates in the U.K. It remains to be seen how, if at all, Brexit will impact regulatory requirements for product candidates and products in the U.K. Regulatory Framework in Australia The Therapeutic Goods Administration, through the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations is responsible for the efficacy, quality, safety and timely availability of drugs and medical devices in Australia. The mission statement of the TGA is “To ensure the safety, quality and efficacy of therapeutic goods available in Australia at a standard equal to that of comparable countries, and that premarket assessment of therapeutic goods is conducted within a reasonable time.” The drug regulation process in Australia is complex and resource intensive. It must be accountable in terms of the quality, safety and efficacy of drugs made available in Australia. This accountability includes an acceptance of a balance between safety and efficacy. The approval process is a detailed evaluation of the data supplied by the company sponsoring an application. 108 A drug may first come to the attention of the TGA when an application for marketing is received or when an Australian clinical trial is being planned. For clinical trials, the sponsoring company may submit preliminary data for evaluation to the TGA or notify the TGA that the trial has been approved by an institutional Ethics Committee. The drug evaluation process for new chemical entities is as follows: Application

| ● | Check to see data complies with Australian guidelines. |

| ● | Invoice sponsor for 75% of evaluation fee. |

Evaluation

| ● | Evaluate pharmaceutical 
 and chemical data.      |

| ● | Evaluate animal pharmacology 
 and toxicology data.         |

| ● | Evaluate clinical data. |

| ● | Evaluation Unit reviews                                                                                     
 reports (coordinates external evaluations if used), prepares a summary and makes an initial recommendation. |

| ● | Pre ADEC consultation with 
 sponsor.                   |

| ● | Prepare approved product                               
 information and consider consumer product information. |

| ● | Submit final package of                                            
 summaries and recommendations to the ADEC (six meetings per year). |

Approval

| ● | ADEC review and advice 
 to the TGA.            |

| ● | Final decision by the TGA. |

| ● | Finalize conditions of