FDA, SEC ordered to fasttrack approval of pending applications

The Anti-Red Tape Authority (ARTA) has ordered the Food and Drug Administration (FDA) and Securities and Exchange Commission (SEC) to approve pending applications, particularly those with complete requirements, following complaints received against the two agencies.

ARTA director general Jeremiah Belgica said in press conference they have issued orders of automatic approval to the FDA and the SEC.

In its order to the FDA dated Sept.9, ARTA directed the agency to issue corresponding permits or licenses to the 3,125 pending applications for renewal of license to operate and authorization or certificate of product registration which are deemed automatically approved or automatically renewed as such have submitted the complete documentary requirements, paid the fees and provided sworn statement indicating no change in the establishment or product.

Under Section 10 of Republic Act (RA) 11032 or the Ease of Doing Business Act and Efficient Government Service Delivery Act, an application or request would be deemed approved if a government agency fails to act on applications within the prescribed processing time.

Belgica said the ARTA issued the order given the complaints received by the authority against the FDA for pending applications.

Apart from issuing an order of automatic approval, he said the ARTA is also making policy recommendations to the FDA to improve processes.

Among the recommendations is for FDA to strengthen its post audit compliance against the grantees of the licenses and permits to monitor and ensure statements made in applications and sworn statements for renewal of licenses and permits are truthful.

“For erring licenses and permittees who made false entries and representations in their application and sworn statement for automatic renewal, it is recommended that the severe penalty of revocation and cancellation of an existing license or certificate be imposed by the FDA… This is without prejudice to the filing of criminal case including a perjury case against the licensee and permittee or any of its duly authorized representative who made the misrepresentation or false entry in the sworn statement or undertaking for automatic renewal of its license or certificate,” ARTA said.

ARTA also recommends for FDA to review and refocus its staffing assignment by designating pharmacists to functions requiring their technical skills and leaving positions requiring ministerial duties like processing applications for renewal to non-pharmacists.

In addition, ARTA is suggesting for FDA to recognize the inspection and accreditation of a plant with the regulatory agency concerned or FDA’s foreign counterpart; for FDA to ask for payment of application fees after the evaluation is undertaken; and for evaluation of applications to be made upon submission of all required documents.

“FDA has been cooperative and very open to reforms. We believe openness of FDA to initiatives would bear fruit sooner,” Belgica said.

As for the SEC, ARTA ordered the agency to issue certification for the four applications for accreditation of auditing firms or external auditors which have complete documentary requirements, duly paid fees and long been awaiting for approval.