Food and Drug Action Center announces half-day work on Dec. 13

Marje Pelayo   •   December 10, 2019   •   366

MANILA, Philippines –  The Food and Drug Administration (FDA) announces half-day work suspension at the Food and Drug Action Center (FDAC) on Friday (December 13).

The half-day suspension is to provide our employees the opportunity to participate in the FDA wide event on the said date.

Thus, office work at FDAC will be suspended from 12:00 noon onwards, the FDA advised its clients.

“Applicants with confirmed schedule to appear on the said date will be accommodated during regular office hours,” the advisory said.

IATF approves Phl participation in COVID-19 vaccine clinical trials

Maris Federez   •   May 24, 2020

MANILA, Philippines — Upon the recommendation of the Department of Science and Technology (DOST), the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-MEID) has approved the proposed participation of the Philippines in clinical trials that seek to formulate a potential vaccine against coronavirus disease 2019 (COVID-19).

Based on IATF Resolution No.39 dated May 22, 2020, the task force has also ordered the creation of a sub-technical working group which will be led by the DOST.

The group will be coordinating with the four collaborating organizations composed of the Department of Health (DOH), the Food and Drug Administration (FDA), the Research Institute for Tropical Medicine (RITM), and the World Health Organization (WHO) with regard to the said clinical trials.

The IATF has also issued a directive to the FDA to facilitate the processing of necessary permits for the conduct of the clinical trials in the country.

The collaborating organizations for the clinical trials are the Adimmune Corporation, Academia Sinica, Chinese Academy of Science- Guangzhou Institute of Biomedicine and Health, the Sinopharm – Wuhan Institute of Biological Products, and the Beijing Institute.

Once the clinical trials are undertaken, these will be included in the FDA’s requirements for the registration process for the vaccine and the application for certificate of registration to make the vaccine available in the market.

The Philippines has initially participated in the WHO’s clinical trials, which include the testing of off-label drugs that show potential of being effective against COVID-19.

Meanwhile, the IATF has also approved the plans of the DOST to construct research centers for the local vaccine research development.

These include the Virology S&T Institute at the New Clark City in Tarlac and the reactivation of the Pharmaceutical Development Unit of the DOST-Industrial Technology Development Institute. —(from the report of Rosalie Coz) /mbmf

DOH admits COVID-19 testing capacity still below 8,000 to 10,000 daily target

Marje Pelayo   •   April 29, 2020

MANILA, Philippines — The Department of Health (DOH) on Wednesday admitted that the country’s testing capacity for coronavirus disease (COVID-19) is still below the target.

The Department had planned to expand its mass testing to 8,000 – 10,000 tests daily starting Thursday (April 30).

But, according to Health Undersecretary Maria Rosario Vergeire, they may not be able to achieve the target as scheduled.

Mukhang hindi po aabot dito sa walong libo for April 30, though sinusubukan natin dahil ngayon po dumating na ang cartridges natin for GeneXpert [I don’t think we can achieve the 8,000 target for April 30 though we are trying, especially with the arrival of the cartridges for GeneXpert,]” the official said.

The DOH was able to conduct a total of 6,320 tests on Tuesday (April 28) in 19 licensed testing laboratories across the country. 

Vergeire noted the recent scaling down of operations at the Research Institute for Tropical Medicine (RITM) as one reason for the delay in testing of samples which left the processing of results pending for about a week.

The RITM has just resumed full operations on Sunday after more than 30 of its COVID-19 positive medical staff recovered from the disease.

With the use of GeneXpert test kits, the DOH expects the results to be out within 45 minutes which will definitely improve the country’s testing capacity and hopefully achieve its daily target.

“But ngayon po itong ating goal ay pilit na maabot, aabutin [We will try hard to achieve our goal in] the coming days as all the resources had been falling in coming from private side and coming from the government,” Vergeire said.

Meanwhile, the Food and Drug Administration (FDA) has added a polymerase chain reaction (PCR) test kit from Singapore and two brands of rapid antibody test kit from Germany and China among the list of approved test kits that may be used in hospitals across the country.

To date, the country has a total of 33 FDA-approved PCR-based test kits and 24 rapid antibody test kits. 

The DOH reminds the public, however, that these test kits may only be administered by licensed doctors and experts who are also authorized to interpret test results. –MNP (with details from Aiko Miguel)

FDA approves 16 COVID-19 rapid test kits

Aileen Cerrudo   •   April 20, 2020

The Food and Drug Administration (FDA) has approved 16 coronavirus disease (COVID-19) rapid antibody test kits for commercial use.

“These applications have completed necessary documentary requirements and have undergone review and evaluation by the FDA,” according to the FDA in a statement.

The rapid test kits detect the presence of antibodies in an individual’s blood or serum. This is to determine if the individual has previously contracted the coronavirus and developed antibodies for it.

FDA Director General Eric Domingo previously said they want people to have access to the testing kits but the testing should still be subjected to proper protocols.

“The rapid test kits will yield a faster result compared to PCR based kits, but it is important that a trained health professional will evaluate and interpret the results,” he said.

The FDA, moreover, reminds the public that each rapid test kits have different specifications and the tests should still be administered by trained health professionals.

“The agency reiterates that these kits are strictly for medical professional use only and not intended for personal use,” the statement reads.

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