The Indonesian Food and Drug Supervisory Agency (BPOM) continues to\nstrengthen efforts to protect the public, one of which is through BPOM\nRegulation No.\u00a04 of 2026 on the Implementation of Pharmacovigilance to\nenhance the oversight of drug safety circulating in Indonesia.<\/p>\n
BPOM Head Taruna Ikrar stated in Jakarta on Friday that the drafting\nof this regulation is also one of BPOM\u2019s efforts to strengthen the\npharmacovigilance system as required by the WHO in order to achieve\nWHO-Listed Authority (WLA) status.<\/p>\n
\u201cThis regulation is one form of strengthening the post-market drug\nsurveillance system in Indonesia to support the government\u2019s priority\nprogramme in handling tuberculosis,\u201d he said.<\/p>\n
According to him, strengthening pharmacovigilance is an inseparable\nneed in the modern drug surveillance system. As the development and use\nof drugs become increasingly complex, the post-marketing surveillance\nsystem must be stronger and more adaptive.<\/p>\n
\u201cPharmacovigilance is key to ensuring that any risks that may arise\nfrom drug use can be detected and mitigated quickly and accurately,\u201d\nsaid Taruna Ikrar.<\/p>\n
He explained that pharmacovigilance encompasses activities including\nthe detection, assessment, understanding, communication, control, and\nprevention of side effects or other issues related to drug use. This\nactivity is an important part of post-market surveillance to ensure that\nthe drugs used remain safe, effective, and of quality throughout their\nlifecycle.<\/p>\n
Through this regulation, BPOM emphasises the obligations of marketing\nauthorisation holders to carry out pharmacovigilance activities\ncomprehensively and continuously. Marketing authorisation holders are\nrequired to monitor drug safety, collect data on side effects or adverse\nevents or post-immunisation adverse reactions, and submit\npharmacovigilance reports to BPOM in accordance with applicable\nprovisions.<\/p>\n
Marketing authorisation holders are obliged to prepare and submit\nrisk management plans as part of the drug registration documents, as\nwell as submit periodic post-marketing safety reports after the drug\nobtains marketing authorisation.<\/p>\n
In addition, this regulation also expands the roles of various\nparties in the national pharmacovigilance system, starting from medical\npersonnel and\/or health workers, as well as encouraging public\nparticipation in reporting drug side effects.<\/p>\n
In addition to strengthening the reporting aspect, this regulation\nalso regulates cooperation between marketing authorisation holders and\nvarious parties, including healthcare facilities as well as third-party\npharmacovigilance implementers.<\/p>\n
\u201cIn order to ensure the availability of accurate and integrated data,\nBPOM also regulates the exchange of drug safety information between\nmarketing authorisation holders with distributors, importers, and\nexporters,\u201d he said.<\/p>\n
The data and reports received will be analysed and evaluated by BPOM\nto determine the necessary control measures. Such follow-up may include\nproduct information updates, implementation of additional safety\nstudies, and restrictions on drug use.<\/p>\n
Not only that, follow-up is also carried out up to temporary\nsuspension or revocation of marketing authorisation. This follow-up is\ncarried out if significant risks to patient safety are found that cannot\nbe mitigated by other control measures.<\/p>\n
As a form of regulatory enforcement, BPOM imposes strict\nadministrative sanctions on marketing authorisation holders who do not\nfulfil pharmacovigilance obligations, ranging from warnings to other\nactions in accordance with statutory provisions, to ensure\ncompliance.<\/p>\n
With the issuance of this regulation, BPOM hopes that the\npharmacovigilance system in Indonesia will become stronger, more\nresponsive, and integrated.<\/p>", "url": "https:\/\/jawawa.id\/newsitem\/bpom-strengthens-pharmacovigilance-oversight-through-perbpom-4-of-2026-1777031491", "image": "" }, "sponsor": "Okusi Associates", "sponsor_url": "https:\/\/okusiassociates.com" }