By JULIA MARI ORNEDO, GMA News
Published May 6, 2021 1:39pm Applications for full registration of a COVID-19 vaccine in the Philippines could possibly be filed this year, the chief of the Food and Drug Administration (FDA) said Thursday. FDA director general Eric Domingo said a certificate of product registration (CPR) requires a completed Phase 3 clinical trial. “You have to complete your Phase 3 trial, meaning talagang natapos na lahat ng endpoints na hinahanap. and then they will see of course dapat ‘yung safety data is very good and ‘yung efficacy data is very high,” he said in an interview on ANC. (You have to complete your Phase 3 trial, meaning all endpoints have been covered… and then they will see of course that the safety data is very good and the efficacy data is very high.)
By JULIA MARI ORNEDO, GMA News
Published May 7, 2021 6:02pm The Food and Drug Administration (FDA) on Friday announced that it approved one local company’s application to register ivermectin as a treatment against roundworms. FDA chief Eric Domingo said “Lloyd Laboratories applied for a CPR (certificate of product registration) for locally manufactured ivermectin as an anti-nematode drug.” Nematodes are roundworms. “It was granted after they submitted data to support [the] quality and stability of the product,” he told GMA News Online in a text message. A CPR is a market authorization that allows a drug to be sold commercially. The antiparasitic drug became controversial in the Philippines after some groups and even lawmakers claimed that it can prevent or treat COVID-19.
(FILE PHOTO)
Metro Manila (CNN Philippines, May 7) The Food and Drug Administration on Friday announced it approved a company s application to register ivermectin as an anti-nematode drug.
Nematodes are roundworms.
FDA Director General Eric Domingo confirmed in a message to CNN Philippines that a certain company Lloyd Laboratories applied for a Certificate of Product Registration for locally-manufactured ivermectin as an anti-nematode drug. It was granted after they submitted data to support quality and stability of the product, Domingo said.
The pharmaceutical company is one of two local firms which earlier expressed intent to register with the FDA for ivermectin production. The other company is Pascual Laboratories Inc., according to reports.
May 5, 2021
Although the anti-parasitic drug ivermectin has not yet been proven effective against COVID-19 in animals, the Department of Agriculture (DA) will also evaluate whether it is effective in pigs against African swine fever (ASF).
Special Order No. 310 released by Agriculture Secretary William Dar on April 30 formed the inter-agency research team for the preliminary trial.
According to Agriculture Undersecretary William Medrano, ivermectin has been found in other countries to be effective as a drug against other viral animal diseases.
“There are scientific literatures already na ivermectin, aside from being an effective anti-parasitic, meron din siyang antiviral effects and anti-inflammatory… Ginamit na sa other countries ‘yung ivermectin sa other viral diseases ng livestock,” said Medrano.