12 Nov, 2018

The PFDA Chief has recently reported that the agency has already reduced around 3,500 backlogs out of 80,000 pending applications, including those that were carried over from previous administrations. It was also estimated that this number will be further reduced by 1,400 following the verification and posting of these applications. These backlogs in processing left unattended to by previous administrations were pointed out to be the reason for the slow process leading to manufacturers and distributors opting to skip registration process, bringing in a number of unregistered products to market.

The director general has announced that the agency has taken drastic moves to get rid of 'nuisance applications', thereby paving way for more efficient systems. She has also warned that PFDA will be setting stricter requirements for future applications in an aim to weed out all nuisance applications and to enable PFDA to attend to the needs of serious and legitimate applicants.

The current director has left a warning to manufacturers stating that failure to submit all requirements within a period of time shall mean automatic disapproval. “This means that a new application will have to be filed and the requirements must be complied within a specified period,” she warned.

On a final note, Medical Device manufacturers and distributors shall be mindful that the current evaluation time takes a slow pace due to clearance of the said backlogs. With the new system to be put into place, it is expected that the turn-around time would be much shorter due to much stricter requirements and a more efficient evaluation system to be implemented by the agency. It is therefore necessary for manufacturers to cope up with this upcoming change by ensuring completeness of all the documents to be submitted during the Initial Registration Application.

 

Reference:

FDA Chief Cites Gains Versus Backlog