MFDS evaluates documents for prolonged COVID-19 crisis

without factual survey

Pre-GMP survey of imported drugs is also determined as a document without exception

The MFDS decided to skip the pre-GMP survey of imported drugs due to the prolonged COVID-19, and to evaluate the documents without exception.

 

The MFDS postponed the survey after the massive outbreak of COVID-19 in February, and document evaluation was conducted for some items without the survey.

 

However, as COVID-19 situation is prolonged, it is a policy to evaluate documents except when the factual survey should be omitted.

 

The pharmaceutical industry is concerned that it is difficult to replace some items with documents without factual survey.

 

According to the industry on the 19th, The MFDS recently prepared and implemented a pre-GMP evaluation plan for such imported drugs.

 

The MFDS has temporarily prepared an evaluation plan when COVID-19 occurred in February of this year.

 

It was decided to omit the factual survey if appropriate by submitting the PIC/s report, the due diligence report by the regulatory authority, and the result of action on the insufficiency of the inspection result.

 

However, for civil complaints that cannot be omitted from the factual survey, the deadline for consultation will be extended until the end of this year, and on-site surveys will be conducted after COVID-19 situation is over.

 

The MFDS, however, is likely to file complaints about the prolonged period of complaint handling due to the accumulation of items that have not been submitted and the prolonged situation due to the prolonged COVID-19.

 

It is a policy to make an enemy or negative decision.

 

This includes DMF complaints.

 

Accordingly, document evaluation is conducted on all items including items not submitted such as PIC/s reports.

 

However, it is a policy to first select the items that need to be subjected to factual surveys as'companies subject to post factual surveys at overseas factories'.

 

In accordance with this full document review process, GMP evaluation essential data (11 types of data, etc.), which are not submitted as a reason for confirmation at the manufacturer factual survey, must also be submitted.

 

Regarding this plan, an official in the pharmaceutical industry said, "If the cases that can be solved only by conducting a factual survey are replaced with documents, it is more difficult." Another official also said, "There are imported drugs that can be replaced with documents, and we are concerned that these items will become non-conformance cases." However, he explained, "If the MFDS only evaluates the documents, the burden on the pharmaceutical industry will be reduced."