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    You are on page 1of 1

    No. : B-SD.02.10.41.07.24.

    1067 Jakarta, July 15th


    2024
    Attachment :-
    Subject matter : Response to Application Request for Collagen Peptide from Giant Squid (Dosidicus
    gigas)

    To honourable.
    PT GWS Prima Sentosa
    on
    Location

    According your letter number 013/GPS-E/V/2024 regarding Application for Review of Collagen
    Peptide from Giant Squid (Dosidicus gigas) dated May 27 th 2024, based on review and evaluation of
    the information and supporting data attached, we would like to convey that further product review
    cannot be carried out due to the inadequate availability of supporting data, as follows:
    1. Quality Data
    a. Requires information of hydrolysis enzymes used in the raw material production process
    b. Requires clarification regarding the composition of the finished product which only contains
    100% peptide and does not contain other additional ingredients. If the raw material contains
    other ingredients, the complete composition should be provided qualitatively and
    quantitatively.
    c. Requires information regarding how to obtain nanotechnology to produce materials in nano
    form, particle size test results which show that the raw materials used are in nanoparticle
    form, and the safety of materials in nanoparticle form.
    2. Safety data
    Requires safety test data (acute toxicity studies and subchronic/chronic toxicity studies) in the
    form of test result document and please attach the result of the review/summary of the safety data
    by the business actor, because there is only MSDS document in the attachment.
    3. Efficacy data
    Requires product efficacy data to support claims related to skin health, including supporting data
    regarding the dosage used and duration of use. Supporting data can be published research results.
    4. Other data
    a. Requires justification by the business actor regarding the use of finished product packaging
    which is in the form of a glass vial with a syringe since the proposed product packaging is not
    commonly used in Health Supplements and resemble with a sterile preparation. Also, requires
    justification related to the use of a syringe to regulate the concentration of water added to the
    powder, while the only way to use the product is by drinking it.
    b. Requires product marketing status in other country that use pre-market registration system.

    To carry out further review, you can complete additional supporting data as stated in points 1-4. We
    hope that documents can be submitted within 15 working days.

    Thereby we convey. For your attention and good cooperation, we thank you.

    on behalf of. tasks executor. The Head of National Agency of Drug and Food Control
    Director of Traditional Medicines, Health Supplements, and Cosmetics
    Dian Putri Anggraweni, S.Si., Apt., M.Farm

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