MFDS reveals detailed clinical trial inspection plan

MFDS says bioequivalence test would be dealt by Drug Equivalence Division and Regional Offices

Sponsors, CRO, institutes should enhance inspection capacity

Clinical Trial Management Division unveils 2020 Master Plan

Korea’s Ministry of Food and Drug Safety (MFDS) plans to conduct extensive inspection on clinical trial regarding pharmaceutical approval.

 

The subjects are new drugs and drugs required to submit evidential data.

 

Accordingly, pharmaceutical companies, CRO, and healthcare institutes would be investigated by Clinical Trial Management Division of MFDS.

 

But, bioequivalence test covered under Good Clinical Practice (GCP) would be investigated by Pharmaceutical Equivalence Division and MFDS Regional Office as usual.

 

As of Feb.

 

11, MFDS disclosed ‘Master Plan 2020 for Pharmaceutical Clinical Trial Audit and Inspection’ on its website.

 

The plan specified ‘the authority would inspect clinical trial institute and sponsor (or CRO) to confirm their credibility of clinical trial and its outcome report.’ The plan stated, a sponsor or CRO who have been inspected in last two years would be exempted.

 

And a clinical research institute would be exempted as well, if it has been inspected during a regular audit, or has been inspected more than three times in past one year.

 

The research institute (principal investigator) would be inspected on followings; general details on clinical trial protocol approval and related contract; adequacy of clinical trial documented by principal investigator or research institute; adequacy of information exchange between principal investigator and institutional Review Board (IRB); adequacy of qualification and training of clinical trial related human resources; adequacy of principal investigator leading clinical trial; adequacy of consent by investigated subject; adequacy of recording and reporting data related to efficacy and safety evaluation; adequacy of managing pharmaceuticals used for clinical trial; and adequacy of laboratory information and human sample management.

 

Sponsors (or CRO) would be inspected on followings; general details of clinical trial (schedule by each phase); adequacy of sponsor’s clinical trial document, standard operating procedure (SOP) system, documentation and management; adequacy of sponsor organization and human resources; adequacy of clinical trial development, protocol, and preparation stages; adequacy of sponsor conducting and managing clinical trial (CRO designation and supervising); adequacy of pharmaceutical quality control for clinical trial-use; adequacy of laboratory information and human body sample management (if applicable); adequacy of monitoring work; adequacy of data management; adequacy of analyzing statistics; adequacy of quality control system and audit task; adequacy of adverse reaction assessment system; and adequacy of protocol, final report and other medical writing.

 

Some had expected that the extensive inspection would target all types of clinical trials executed for pharmaceutical approval, including bioequivalence test.

 

But the Clinical Trial Management Division at MFDS confirmed it would only target new drugs and items required to submit documents.

 

Bioequivalence test would not be a part of Clinical Trial Management Division’s inspection.

 

Instead, MFDS Pharmaceutical Equivalence Division and Regional Offices would be in charge of post-management.

 

Bioequivalence test has never been a part of clinical trial inspection.

 

MFDS official explained, “Regular inspection on bioequivalence test has been discontinued, but it is conducted when needed.

 

Healthcare institute, analytic institute and manufacturing company are all applicable for the inspection.” The industry, however, advises pharmaceutical companies, CRO and healthcare institutes running bioequivalence test should prepare for MFDS’ inspection, as it has been managed under Korea Good Clinical Practice (KGCP) from 2017, and the Bioequivalence Test Management Standard has been abolished from last October.

 

An industry insider explained, “For previous bioequivalence test inspection, only the institute analyzing human body sample used be the subject.

 

But as MFDS is tightening the regulation based on KGCP, pharmaceutical companies, CRO, and healthcare institute should also reinforce self-inspection capacity to generally improve clinical trial quality than only focusing on analysis.” The insider specifically suggested, “Small and medium pharmaceutical companies lacking inspection staff should also enhance audit capacity.

 

Entrusting the inspection work to CRO could be a solution.”