MFDS cautious about strengthening regulations

on conditionally approved drugs that require Phase III trial after commercialization

“Need to sufficiently listen to opinions to secure receptivity in the industry”

The Korean Pharmacists Association for a Healthy Society agrees on the need to strengthen safety management... KRPIA opposes due to the potential increase in labor and time burden

The Ministry of Food and Drug Safety explained that although the MFDS with the purpose of the legislation to strengthen regulations on drugs that have been conditionally approved for expedited marketing authorizations before completing Phase III clinical trials from the current guideline level to the Pharmaceutical Affairs Act level, its application will require ample collection of opinions from stakeholders.

 

In other words, the MFDS has a cautious stance regarding the reinforcement of related regulations.

 

However, there was also the opinion that mandating all matters related to conditional expedited approval drugs to be decided through the Central Pharmaceutical Affairs Committee could lead to delay and overload of work in practice.

 

Regarding the bill, the Korean Pharmacists Association for a Healthy Society expressed its support for its legislation while Korean Research-based Pharmaceutical Industry Association (KRPIA) took an opposing stance.

 

On the 20th, the Ministry of Health and Welfare's position was included in the review report on the proposal for the amendment to the Pharmaceutical Affairs Act, which included reinforcing regulations of conditionally approved drugs, that was presented by the Democratic Party of Korea Rep.

 

Jong-Yoon Choi.

 

Choi’s bill stipulates that if a pharmaceutical company that has received conditional approval for a Phase III trial wants to extend the data submission period, including those for clinical trial data, it must apply for the extension to the Minister of Food and Drug Safety in advance and the minister shall listen to the opinions of the CPAC and decide whether to extend the period.

 

It also contains a mandatory provision for pharmaceutical companies that have received conditional approval for items shall report their plans to submit data, such as clinical trial data of its users, to the Minister of Food and Drug Safety within 3 months from the date of approval.

 

Also, the report on the implementation status of the reported plan, such as the status of clinical trials, was increased from the current once a year to semi-annually, that is, twice a year, to the Minister of Food and Drug Safety.

 

However, no separate provisions for punishment were prepared for their non-compliance.

 

To the bill, the Expert Committee of the National Assembly's Health and Welfare Committee judged that when considering the characteristics of conditionally approved drugs, there is a need to stipulate provisions in the current management guidelines to check whether the conditions to submit clinical data have been fulfilled.

 

Specifically, to extend the deadline for submitting clinical trial data for currently conditionally licensed drugs, the MFDS first conducts an internal feasibility review, and then, if necessary, consults with the CPAC or external advisors before finally deciding whether to adjust the conditions for approval, such as by extending the submission deadline.

 

The expert committee members agreed that a stricter review of the data submission obligation may be needed so that companies do not neglect the data submission obligation or abuse the extension system.

 

On the part, the experts agreed with the purpose of the amendment, which will stipulate the procedure for extending the data submission period by law rather than just a guideline as in the current state and require CPAC advice when deciding on allowing the extensions.

 

However, the committee also added that the opinion that MFDS’s compulsory consultation with the Central Pharmacy on all matters regardless of the severity of the case, could cause work delay.

 

Regarding the provision to report the clinical trial plan to the Minister of Food and Drug Safety within 3 months from the date of approval of conditional approval drugs, the expert committee said that the provision does not conform to the reality of the situation as a clinical trial of some drugs are not approved at the time the conditional approval is granted.

 

Also, the expert committee diagnosed that increasing the number of reports to the MFDS on the progress of clinical trials from the current once a year to twice a year would be beneficial for management as it will allow the authorities to quickly be known of changes made in clinical trials.

 

At the same time, the expert committee asked for the authorities to comprehensively review the opinion that it may increase the risk of administrative burden on the pharmaceutical industry.

 

Regarding the bill, the Ministry of Food and Drug Safety took a neutral stance, saying, “We will need to sufficiently collect industry opinion,” stating the need to minimize resistance from the pharmaceutical industry and secure receptivity for the regulations.

 

The MFDS said, “We agree with the purpose of the amendment to strengthen the management and supervision of conditional approval drugs.

 

However, further review will be needed in consideration of the working-level business process.

 

"We need to sufficiently collect opinions from the industry to secure regulatory acceptance.” The Korean Pharmacists Association for a Healthy Society agreed to the bill, saying, “The bill strengthens the safety verification of conditionally licensed drugs.

 

We agree with the purpose of the amendment to strengthen the responsibility of the MFDS in verifying drug safety, by requiring CPAC review when deciding whether to extend the submission period for clinical data for conditionally approved drugs." However, the Korean Research-based Pharmaceutical Industry Association opposed the bill.

 

“In the case of conditionally licensed drugs, 6 months is generally too short to report any significant changes that require MFDS attention to the authorities.

 

Semi-annual submission of reports will increase the burden of time and labor for companies."