BPOM Affirms Imported US Medicines Still Required to Have Marketing Authorisation Number

BPOM: Imported US Medicines Still Required to Have Marketing Authorisation Number

• Yeni Lestari/VIVA

Jakarta, VIVA – The Head of the National Agency of Drug and Food Control (BPOM), Taruna Ikrar, has affirmed that imported food, pharmaceutical, and cosmetic products from the United States (US) circulating in Indonesia must still have a valid Marketing Authorisation Number applicable in Indonesia.

He stated this in response to circulating issues regarding the trade agreement concerning reciprocal tariffs, or Agreements on Reciprocal Tariff (ART), with the US, which includes the point that the trade of medical devices/pharmaceuticals from the US in Indonesia does not require BPOM standards, as they have previously obtained approval from the US Food and Drug Administration (FDA).

“This does not mean that all products from the United States entering Indonesia will bypass the BPOM, because the legal requirements still stipulate that they must obtain a Marketing Authorisation Number from the BPOM,” said the Head of BPOM, Taruna Ikrar, when met in Jakarta on Wednesday.

Taruna emphasised that the Marketing Authorisation Number issued by the BPOM remains necessary, even though the BPOM and the FDA have similar standards from the World Health Organization (WHO).

He added that both of these food and drug regulatory authorities are part of the WHO-Listed Authority.

“This means that all drugs to be imported into Indonesia have the same standards. Therefore, the requirement is that they must first obtain a Marketing Authorisation in the United States. Then, after entering Indonesia, they must also obtain Marketing Authorisation from the BPOM, which is what we refer to as the (Marketing Authorisation Number) for imported drugs,” said Taruna Ikrar.

Taruna assured that the quality, safety, and efficacy of drugs imported from the US will continue to be ensured, while also paying attention to the protection of Indonesian consumers.

“The BPOM will continue to play its role, and the BPOM will not be left out. So, drugs and anything imported from the United States must still meet the aforementioned requirements,” he said.

Previously, the Cabinet Secretary, Teddy Indra Wijaya, also emphasised that cosmetic products and medical devices are also subject to supervision. Both are required to have a marketing authorisation and certification from the BPOM before they can be circulated in the domestic market.

“Cosmetic products and medical devices are required to have certification from the BPOM,” he said. (Ant)