FDA Chief Orders Clean-Up Of Backlog

The Food and Drug Administration (FDA) is set to take drastic moves to address the backlog in the processing of various applications which the agency has inherited from the past.

According to the FDA, this is part of its efforts to create more efficient systems and to get rid of so-called “nuisance applications”.

FDA Director-General Nela Charade Puno announced that she is issuing a directive which will lead to the immediate disposition of all applications for food and drug products that have been pending with the FDA for a period of six months or more.

“Starting September this year, applications for license to operate and product registration pending with the FDA for a period of six months or more will be approved provided they have fully complied with the requirements, including the payment of fees," Puno said. “This will clear the way for the implementation of a better system for filing and processing of applications and the claiming of approved permits and certificates of product registration (CPR),” she explained.

Puno announced that permits and CPRs granted through this initiative will still be subjected to back-end checks “following safety nets we have put in place to protect public health and well-being”.

She clarified that this is a “one-time procedure” and will be completed by the last quarter of this year.

“I want to make it clear that this is not a policy, but just an intermediate step to the implementation of a more efficient system,” Puno said.

“Future applicants should not expect automatic approvals just because their applications were not completed within six months,” she pointed out.

She also warned that the FDA will set stricter requirements for future applications “to weed out the nuisances and to enable the FDA to attend to the needs of serious and legitimate applicants”.

Puno pointed out that the current backlog “appears to have been at the FDA for close to a decade and have been left unattended”. She said the backlog involves some 80,000 applications that have not been completed in the past. With the move, she said she expects to clear the longstanding backlog by 80 percent.

 A large percentage of the backlog is the result of the inability of applicants to submit product registration requirements, she explained.

“Under the new system we shall put in place, the failure the submit all requirements within a period of time shall mean automatic disapproval,” Puno said. “This means that a new application will have to be filed and the requirements must be complied with within a specified period,” she warned.

Puno said the moves are in line with commitments made by the FDA at the beginning of the current administration. “This follows the directive of President Duterte that the agency should be rid of inefficient and corrupt elements and that the public should be given higher standards of service,” she explained.

Puno said the backlog in the processing of applications she inherited “is also responsible for the proliferation of unregistered food and drug products in the black market”. “Because of the slow process, manufacturers and distributors in the past had opted to skip registration and just brought their products to the market right away,” she explained.

“This poses risks to the public since unregistered products have not been properly evaluated for safety and efficacy,” Puno added.

The FDA head also warned that she will not allow delays in the processing of applications “that are caused by internal human factors, such as the inefficiency and corruption on the part of our personnel”.

She called on applicants to report any unwarranted actions on the part of any FDA personnel that may jeopardize the efficiency and integrity of the FDA processes.

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