Show-cause order issued to FDA drug center for alleged inaction on over 600 applications

Marje Pelayo   •   May 12, 2021   •   248

MANILA, Philippines – The Anti-Red Tape Authority (ARTA) has issued a show-cause order to the Food and Drug Administration (FDA) Center for Drug Regulation and Research (CDRR) for allegedly not acting on over 600 drug applications despite having complete requirements.

The order, sent on Tuesday (May 11) by ARTA Investigation Enforcement and Litigation Director Jedrek Ng, directs FDA-CDRR Director IV Jesusa Cirunay  to “explain why no administrative or criminal case should be filed” against her over delays in applications of various pharmaceutical companies filed as far back as 2014 or so.

“Pag titingnan po ito ang mga applications na ‘to di ito kumplikado. Ito yung mga aplikasyong for automatic renewal. Ito ay mga produkto na dati nang ginagamit at ngayon ay gusto lang i-register o yung iba naman ay low to no risk sa taumbayan,” ARTA director general Jeremiah Belgica said.

“Di namin maintidihan kung bakit ito ay naiipit at ito ay palagi na nangyayari diyan sa FDA particularly sa Center for Drugs. Ito ay mga aplikasyon na pwedeng aprubahan ng center director,” he added.

Cirunay is given seven working days from receipt of the order to conduct an inventory of all pending permit, license, clearance or application; immediately release all said applications which have been pending beyond the prescribed processing time.

Also, she is directed to submit to ARTA a compliance report with a list of all permits, licenses, clearances or applications issued pursuant to the show cause order.

If Cirunay fails to comply, ARTA will resort to the filing of formal charges against her in accordance with Republic Act No. 11032 or the Ease of Doing Business and Efficient Government Service Delivery law before the Office of the Ombudsman.

Belgica also urged Health Secretary Francisco Duque III and FDA Director General Eric Domingo to remove, if necessary, their erring officials and personnel.

ARTA urges uniformed personnel to report delays in processing of benefits claims

Marje Pelayo   •   May 24, 2021

MANILA, Philippines — The Anti-Red Tape Authority (ARTA) reiterates its reminder to uniformed personnel who have existing benefit claims to report to the agency any delays in their applications.

ARTA Undersecretary Carlos Quita said they have provided an email account that is exclusive only to the members of the Armed Forces of the Philippines (AFP) and the Philippine National Police (PNP)

All other individuals with problems in their benefit claims and other matters may forward their concerns through ARTA.gov.ph.

In addition, the agency signed a joint circular creating a task force that will manage the streamlining of the processes to assist military and police personnel in their benefit claims.

Quita said the very purpose of this is to improve existing systems and integrate them into one streamlined system that can be managed both at the local and national level. It will also allow claimants to access the system online.

The joint circular was signed by representatives from ARTA, the Department of the Interior and Local Government (DILG), National Police Commission (NPC), Philippine Statistics Authority (PSA), AFP, PNP, Philippine Coast Guard, Bureau of Fire Protection, and Bureau of Jail Management and Penology (BJMP).

ARTA launches task force to fast-track benefit claims of uniformed personnel

Aileen Cerrudo   •   May 22, 2021

MANILA, Philippines—The Anti-Red Tape Authority (ARTA) has launched a task force that would fast-track the processing of benefit claims of uniformed personnel.

The task force was officially established on Thursday (May 20) during a virtual ceremonial launching. It aims to create policies that would streamline the processing of claims of the legal beneficiaries of uniformed personnel. It aims to automate the death benefit claims and other entitlements of the beneficiaries. A one-stop-shop would also be placed in various regions and localities.

ARTA Director General Secretary Jeremiah Belgica said the agency had to respond to the difficulties faced by the relatives of uniformed personnel in claiming benefits. This was also following the directive of President Rodrigo Duterte  in March 2021 to automate and speed up the processing of death benefit claims of uniformed personnel.

ARTA Deputy Director General for Administration, Finance Usec.  Carlos Quita will serve at the helm of the task force as its chairman. The task force is composed of members of Philippine Statistics Authority (PSA), National Police Commission (NAPOLCOM), Armed Forces of the Philippines (AFP), Philippine National Police (PNP), Philippine Coast Guard (PCG), Bureau of Fire Protection (BFP), and Bureau of Jail Management and Penology (BJMP).

The agency has also set up afppnpclaims@arta.gov.ph, a dedicated email for beneficiaries to send their concerns on processing their claims. AAC

ARTA signs joint memorandum to expedite permitting process for local vax manufacturers

Aileen Cerrudo   •   May 20, 2021

MANILA, Philippines — The Anti-Red Tape Authority (ARTA) signed a joint memorandum circular (JMC) with other key government agencies to speed up the permitting process for local vaccine manufacturers.

On Wednesday (May 19), ARTA together with the Department of Health (DOH), Food and Drug Administration (FDA), Department of Trade and Industry-Board of Investments (DTI-BOI), Department of Science and Technology (DOST), and National Task Force Against COVID-19 (NTF-COVID19), have signed the memorandum circular where agencies involved in the permitting process such as the FDA shall follow the green lane’s guidelines.

“Bulk supplies of vaccines will be imported from abroad and the local companies will fill and package vials locally for distribution,” the JMC read.

Under the green lane, applications for a License to Operate (LTO) as a vaccine manufacturer shall take no more than 20 working days and it would enable pharmaceutical companies to put up manufacturing facilities within 10 months.

The JMC is a response to President Rodrigo Duterte’s directive to lessen the Philippines’ dependence on COVID-19 vaccine importation and capacitate the country in developing its own vaccines. -AAC

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