ARTA declares pending FDA applications automatically renewed
The Anti-Red Tape Authority (ARTA) has declared 2,250 applications automatically renewed after the Food and Drug Administration failed to act on those documents.
A Declaration of Completeness and Order of Automatic Renewal was issued to the Center for Drug Regulation and Research (CDRR) of the Food and Drug Administration (FDA) for 2,250 low risk to no risk Automatic Renewal Applications of Certificate of Product Registration (CPR) which were left pending at the end of 2020.
The order was issued following a visit by ARTA Director General Jeremiah Belgica last January 20, 2021 to the FDA office in Alabang and after ARTA’s warnings last year to the agency that all applications under automatic renewal must be renewed immediately. In the meeting and walk-through with FDA, ARTA was able to inspect and monitor the FDA office to see its compliance to R.A. 11032.
The CDRR sent the list of 2,250 pending applications from 325 companies and entities that are already for automatic renewal. These applications have been verified by the Food and Drug Action Center as complete and fully paid for.
“These applications for Automatic Renewal should have been acted upon within 3 days from its complete payment and submission of requirements. Those which remain to be pending up until now are already deemed automatically renewed by law. It is important to point out that these products are not new but have been in the market and used by the public that is why there is little to no risk already. They only seek for the renewal of their CPRs." ARTA Director General Jeremiah Belgica explained.
By operation of law and pursuant to Section 3 (B) (2) of Book II, Article I of the Implementing Rules and Regulations of Republic Act No. 9711 or the Food and Drug Administration Act of 20091 in relation to Section 10 of R.A. No. 11032 or the Ease of Doing Business and Efficient Government Service Delivery Act of 20182, said applications are declared complete and automatically renewed.
The CPRs shall be valid once FDA has officially complied with the issuance. The CDRR, through Director Jesusa Joyce N. Cirunay, is directed to notify the applicants and submit a compliance report to ARTA within three days from the receipt of this order. Failure to comply may result in administrative sanctions.
"We are asking all agencies to make sure that we comply with the automatic approval provisions of the ARTA Law. Otherwise, you might face administrative sanctions or even criminal liability," Belgica said.
ARTA has targeted FDA since the start of its mandate following complaints from small businesses on the slow action on their applications even if their documents fall under automatic renewal only. ARTA had already called the attention of FDA since 2019 and ordered to automatically the applications under “automatic renewal.”