RMP evaluation cycle Up to 3 yrs What items can be changed?

Ministry of Food and Drug Safety prepares revision of drug risk management plan guideline

Items that can change the risk management plan (RMP) cycle up to three years have been determined.

 

The Ministry of Food and Drug Safety recently enacted an amendment (draft) to the 'drug risk management plan guidelines and specifically included the targets for changing the RMP reporting cycle, related documents, and procedures for reviewing the feasibility of the change.

 

In the case of RMP-submitted drugs, safety evaluation or benefit/risk evaluation, such as clue analysis, is conducted every 6 months from item approval until 2 years, and every 1 year after 2 years have elapsed, and the results are submitted after the expiration of the relevant period.

 

It must be reported to the Ministry of Food and Drug Safety within one month.

 

However, in the future ▲Items that have completed re-examination in accordance with Article 32 of the Pharmaceutical Affairs Act ▲Items for which additional pharmaceutical surveillance activities (post-marketing surveillance) have been completed ▲Items for which 4 years have elapsed since marketing if other pharmaceutical surveillance activities are not established ▲RMP after product approval In the case of drugs designated for submission, the RPM evaluation cycle can be changed to a maximum of 3 years or less for items for which 4 years have elapsed since the date of change of approval following the RMP submission.

 

However, the plan may be changed if essential changes have occurred to the relevant item, such as the addition of new indications or changes in usage and dosage, or if evaluation and reporting of RMP implementation results are required at a shorter cycle than the changed cycle due to pharmacovigilance, etc.

 

If it is judged that it is necessary to shorten the evaluation cycle due to issues such as safety, the RMP plan can be changed.

 

In the case of drugs with high safety concerns, such as anticancer drugs, antibiotics, drugs for the nervous system, narcotics, orphan drugs, and biological products, whether they fall under the review of changing the evaluation cycle and the need for the change must be separately considered.

 

The Ministry of Food and Drug Safety ▲occurrence or change of important clue information, benefit/risk analysis/evaluation results, etc.

 

▲clinical characteristics of established safety review items and types and characteristics of bad information ▲deletion or change of safety review items and additional risk mitigation measures ▲ The RMP cycle can be changed by reviewing the appropriateness of the implementation of the risk management plan that has been implemented so far ▲ the characteristics of formulations with low risk of safety problems ▲ consideration of the overseas safety information evaluation cycle and differences.

 

When changing the periodic reporting period, the change of evaluation start point is not applicable except in unavoidable circumstances.

 

The Ministry of Food and Drug Safety said, "The change in the evaluation cycle of the RMP is to review the feasibility of the target item and change the implementation result evaluation cycle period to a maximum of three years or less." "he said.