Preparing to license the circulation of 3 drugs molnupiravir in Vietnam

At the meeting, the Council carefully and carefully considered the appraisal opinions of the specialized subcommittees, leading experts in the field of quality standards, preparation, clinical pharmacology and agreed on the topic. The Ministry of Health has issued a conditional circulation registration certificate for 3 drugs containing the active ingredient molnupiravir. Currently, the Ministry of Health has not announced the list of companies that will produce these three new drugs.

Specific conditions for strict control of drug quality after being granted circulation registration certificates are required by the Council for drug manufacturers, including: The first, Carry out satisfactory quality inspection of raw materials before production. Monday, continue to monitor and check drug quality monthly after being granted a circulation registration certificate and report to the management agency for close supervision on the quality and shelf life of the drug. Tuesday, continue to carry out drug stability studies and submit research data, updated records of expiry dates for appraisal according to the guidelines and requirements of the ASEAN Common Technical Dossier.

For unapproved dossiers, the Council recommends that manufacturing facilities continue to urgently research and supplement documents, data and research results on drug quality standards, drug stability, and drug quality standards. medicine. The Board will urgently meet to consider the licensing as soon as the results of the additional application review by the specialized subcommittees are available.

Regarding the issuance of circulation permits for drugs to treat Covid-19, the Minister of Health requested the management agencies and specialized units to strictly control the quality and manage the prices in accordance with the provisions of the Law on Pharmacy, against all negative manifestations, group interests in the supply of drugs.

Molnupiravir is an active ingredient with antiviral effects, which is in the testing phase and has not yet been licensed for circulation in Vietnam. However, this drug is considered an important “weapon” in the treatment of F0 at home, because it reduces the viral load when used in the early stages of the disease, thereby reducing the risk of exacerbation and death.

As of January 5, the Ministry of Health has allocated a total of more than 300,000 doses of molnupiravir to Pilot program for controlled treatment of mild cases of Covid-19. This program has been implemented in Ho Chi Minh City since mid-August and is currently expanding to 51 epidemic-affected localities.

Molnupiravir along with favipiravir, remdesivir are 3 antiviral drugs that have been included in the Covid-19 treatment regimen by the Ministry of Health in Vietnam, but none have been licensed. Molnupiravir and favipiravir are two oral antiviral drugs that are easy for F0 to treat at home. Meanwhile, remdesivir is an intramuscular injection, used for critically ill patients, for use only in hospitals.

Recently, the Ministry of Health announced the results of the molnupiravir trial, which recorded that nearly 100% of patients taking the drug had a low viral load, a very low rate of severe disease, and no deaths.


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