{
    "success": true,
    "data": {
        "id": 1569563,
        "msgid": "bpom-affirms-imported-us-medicines-still-required-to-have-marketing-authorisation-number-1772004682",
        "date": "2026-02-25 12:10:28",
        "title": "BPOM Affirms Imported US Medicines Still Required to Have Marketing Authorisation Number",
        "author": "",
        "source": "VIVA",
        "tags": "berita",
        "topic": "Regulation",
        "summary": "Indonesia's pharmaceutical regulator BPOM has clarified that imported US medicines must still obtain Marketing Authorisation Numbers from the agency, despite concerns arising from the reciprocal tariffs agreement (ART) with the United States. The clarification addresses misconceptions that FDA approval would exempt US pharmaceutical products from Indonesian regulatory requirements.",
        "content": "<p>BPOM: Imported US Medicines Still Required to Have Marketing\nAuthorisation Number<\/p>\n<ul>\n<li>Yeni Lestari\/VIVA<\/li>\n<\/ul>\n<p>Jakarta, VIVA \u2013 The Head of the National Agency of Drug and Food\nControl (BPOM), Taruna Ikrar, has affirmed that imported food,\npharmaceutical, and cosmetic products from the United States (US)\ncirculating in Indonesia must still have a valid Marketing Authorisation\nNumber applicable in Indonesia.<\/p>\n<p>He stated this in response to circulating issues regarding the trade\nagreement concerning reciprocal tariffs, or Agreements on Reciprocal\nTariff (ART), with the US, which includes the point that the trade of\nmedical devices\/pharmaceuticals from the US in Indonesia does not\nrequire BPOM standards, as they have previously obtained approval from\nthe US Food and Drug Administration (FDA).<\/p>\n<p>\u201cThis does not mean that all products from the United States entering\nIndonesia will bypass the BPOM, because the legal requirements still\nstipulate that they must obtain a Marketing Authorisation Number from\nthe BPOM,\u201d said the Head of BPOM, Taruna Ikrar, when met in Jakarta on\nWednesday.<\/p>\n<p>Taruna emphasised that the Marketing Authorisation Number issued by\nthe BPOM remains necessary, even though the BPOM and the FDA have\nsimilar standards from the World Health Organization (WHO).<\/p>\n<p>He added that both of these food and drug regulatory authorities are\npart of the WHO-Listed Authority.<\/p>\n<p>\u201cThis means that all drugs to be imported into Indonesia have the\nsame standards. Therefore, the requirement is that they must first\nobtain a Marketing Authorisation in the United States. Then, after\nentering Indonesia, they must also obtain Marketing Authorisation from\nthe BPOM, which is what we refer to as the (Marketing Authorisation\nNumber) for imported drugs,\u201d said Taruna Ikrar.<\/p>\n<p>Taruna assured that the quality, safety, and efficacy of drugs\nimported from the US will continue to be ensured, while also paying\nattention to the protection of Indonesian consumers.<\/p>\n<p>\u201cThe BPOM will continue to play its role, and the BPOM will not be\nleft out. So, drugs and anything imported from the United States must\nstill meet the aforementioned requirements,\u201d he said.<\/p>\n<p>Previously, the Cabinet Secretary, Teddy Indra Wijaya, also\nemphasised that cosmetic products and medical devices are also subject\nto supervision. Both are required to have a marketing authorisation and\ncertification from the BPOM before they can be circulated in the\ndomestic market.<\/p>\n<p>\u201cCosmetic products and medical devices are required to have\ncertification from the BPOM,\u201d he said. (Ant)<\/p>",
        "url": "https:\/\/jawawa.id\/newsitem\/bpom-affirms-imported-us-medicines-still-required-to-have-marketing-authorisation-number-1772004682",
        "image": ""
    },
    "sponsor": "Okusi Associates",
    "sponsor_url": "https:\/\/okusiassociates.com"
}