Integrating PMS with RMP to protect new drug information

MFDS to gradually implement changes in post-marketing safety management system by 2022

The post-marketing surveillance (PMS) system that monitors new drug’s adverse reaction experienced by patients to maintain the drug safety would be integrated with the risk management plan (RMP) review system.

 

The number of investigated subjects would be reasonably adjusted and the data protection system for the authorized new drug would be created separately.

 

On July 16, Korea’s Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) announced a plan to revise the post-marketing drug safety management system that mainly focuses on integrating the current PMS with RMP, which aims to manage a drug safety in all lifecycle.

 

Implemented from 1995, Korea’s PMS reevaluates safety and efficacy of new drug or some prescription drug by investigating adverse reaction reported from uncertain number of samples.

 

The PMS system not only monitors adverse reaction reports after the product release, but it also protects product information and restricts follow-on drug’s marketing approval.

 

The RMP, in effective from 2015, basically enforces new drugs and rare disease drugs to draw up and comply with comprehensive safety management plan including pharmacovigilance plan and routine risk minimization activities.

 

But apparently, the public has been raising their voices demanding for a systematic improvement, as 77.5 percent of the RMP subjects were selected again as subject for PMS.

 

To prevent redundancy and harmonize with international standard, MFDS intends to gradually implement the changes.

 

For the first phase to be implemented by the end of the year, the redundancy in RMP and PMS would be removed.

 

And by the end of 2021, the second phase would enhance the efficiency in RMP and by the end of 2022, the integrated RMP would cover the entire post-marketing safety management system.

 

The three key amendments of the plan are harmonizing with the international post-marketing drug safety management system, streamlining pharmacovigilance system by reinforcing collected safety information, and establishing data protection system.

 

The first phase would be on reasonably adjusting information submission criteria to remove redundant data submission by conducting RMP and PMS review simultaneously.

 

The overlapping materials for regular report would prioritize RMP review, and the ‘post-marketing investigation’ section would be replaced by PMS.

 

And for the post-marketing investigation fitting to each quality of drugs, the government plans to revisit the calculation of the number of subject based on prevalence rate and indications.

 

Currently, the sample subject number is limited to 600 to 3,000, but the bracket would be better calculated according to the qualities of each product.

 

The phase 2 of the policy revision would establish a legal basis and raise the administrative predictability by clarifying the compliance criteria.

 

The key amendments are on integrating PMS and RMP subjects, improvising RMP submission period and procedure, reinforcing submission of periodic safety update reports, and strengthening adverse reaction analysis by priority review types.

 

The third phase intends to unify the entire post-marketing safety management as a RMP review.

 

The government aims to harmonize with the international standard of post-marketing drug safety management system by integrating PMS with RMP, and opening a data protection system.

 

Minister Lee Eui-kyung said, “The importance of post-marketing drug safety management has been highlighted by monitoring the adverse reactions of drugs unpredictable at the time of approval and using the safe drugs,” and “the ministry would continue to strengthen the post-marketing safety management by gradually improving the system efficiency between the government and the industry.”