FDA to address backlog

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

FDA Director-General Nela Charade Puno said she would issue a directive that would lead to the immediate decision on all applications for food and drug products that had been pending with the FDA for six months or more.

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

Permits and CPRs granted under this initiative would still be subject to back-end checks.
This, she said, would be a “one-time procedure” and would 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.