"BPOM carried out innovation by revitalizing the effective pharmacovigilance system through the BPOM Regulation Number 15 of 2022 concerning the Implementation of Pharmacovigilance," the head of the agency, Penny K. Lukito, informed in a statement released on Tuesday.
In accordance with the regulation, one of the pharmacovigilance implementation stages is regulating the RMPs of the pharmaceutical industry as part of pre-market supervision, she said.
Lukito explained that the RMP is a document that is designed to identify, determine characteristics, and prevent, or minimize the risks of drugs before they are distributed.
"The pharmaceutical industry has an obligation to prepare RMP documents that cover the drug development process to product distribution. This document is an inseparable part of the product registration document," she said.
According to her, the implementation of the obligation to prepare RMP documents has been carried out in stages. Based on data for the January–August 2023 period, RMP document submissions have only reached 30 percent of all new drug registration applications received by the agency.
Therefore, the BPOM is holding a workshop related to RMP document preparation from September 19–21, 2023, to assist the pharmaceutical industry in preparing RMP documents, strengthen efforts to implement RMPs, including Environmental Risk Assessment (ERA) at the drug registration stage, and strengthen BPOM's evaluators in evaluating RMP documents.
"In general, the RMP document preparation aims to identify early product risks and sectors that require further evaluation," Lukito said.
In the future, RMPs will also be needed to plan new research to identify the risks of drugs to prevent negative impacts on patients and the environment, she added.
"RMP documents must contain ERA. We need to identify the risks of drugs from the start and plan action to avoid it," she disclosed.