The FDA warns against unregistered drug products, including the Fabunan antiviral injection, that are being promoted as treatments for COVID-19. COVID19PH
While advocates claim that the drug may be a cheap home treatment and that it could cure COVID-19 in 3 days, the antiviral injection cannot be sold or distributed without being registered.
For drug distributors, requirements include an application form, proof of business name registration, credentials of the pharmacist, risk management plan, location plan, proof of payment, and self-assessment tool kit. Only after securing a license can a drug establishment apply for a CPR, which would allow it to engage in activities such as the importation, distribution, or sale of a drug product.
Clinical documents are also required, covering summaries of clinical pharmacology, efficacy, and safety, among other studies. Thus, the CDRR said applications of drug products related to COVID-19 are expedited."This is to ensure that there is enough supply of registered drugs for its indicated disease and also as possible treatment for COVID 19," the CDRR said.
"No drug has been approved with a specific indication for the treatment of COVID-19 in the Philippines," the CDRR said.
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