Renewal of Marketing Approval for drugs, will be reinforced

Drugs without sales records can not be renewed

The MFDS promotes Renewal of Marketing Approval of drugs

It was originally possible to renew under circumstances having production or income achievements within 5 years validity.

Renewal System of Marketing Approval for Drugs ongoing since 2018 will be further reinforced.

 

The system which gives a 5 year validity for each category respectively, renews allowance after reviewing safety and effectiveness.

 

However, it is criticized that the screening does not properly evaluate the safety and effectiveness of pharmaceuticals.

 

Accordingly, the MFDS decided to strengthen the renewal review by comprehensive review of ingredients and formulations, refrain from renewing unsold items, and compulsory submission of post-market safety data.

 

According to the industry on the 30th, the MFDS recently released the first comprehensive plan for drug safety management (from 2020 to 2024).

 

In the comprehensive plan of the MFDS, the drug renewal system is currently reviewing and evaluating safety, efficacy, and quality data for each drug, but the need for comprehensive review and evaluation by ingredient and formulation is increasing.

 

The background of the plan to strengthen the item update was explained.

 

Furthermore, the MFDS explained that worries exist because even though they have eliminated not produced or not imported items during the 5 year validity from the renewal objects, cases where after the minimum quantity is manufactured and imported for the purpose of passing through the renewal, in which the legal compliance (quality management, safety management after marketing) is not observed, are occuring.

 

Accordingly, the MFDS suggested strengthening ▲the submission of safety data for items subject to renewal ▲ evaluating safety and effectiveness of each ingredient and formulation ▲ not being able to update drugs without sales within the expiration date.

 

First, from 2021, it was decided to submit safety information promptly and regularly, including side effects during the expiration date, and to analyze and evaluate the information and data on safety management measures.

 

In addition, from 2023, it is a policy to collect and analyze safety information at home and abroad for some items and to submit a comprehensive report on safety management after marketing.

 

The MFDS also announced that when reviewing the renewed ingredients for the first time this year, the entire domestic review of the same ingredients and formulations will be conducted to prepare a comprehensive review and continuously update.

 

In particular, from 2023, it was obliged to submit action plans, including comparison and analysis of domestic and foreign permits, and changes to permits for some items.

 

Drugs without sales records could not be renewed.

 

Currently, only the results of manufacturing and imports are reported during the renewal examination.

 

The MFDS is planning not to renew even if it has not been manufactured, imported, or sold during the validity period (5 years) of the item permission and notification from 2021.

 

It is expected that the burden of pharmaceutical companies will increase if it is mandatory to submit safety data after marketing and items without sales records are not allowed to be renewed.