Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 66

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 66
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    ●
    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 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.

34

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.

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