GOOD NEWS: Proposal to issue circulation registration certificates for 3 drugs to treat COVID-19 made in Vietnam

At the meeting on the afternoon of January 5, the Advisory Council for the issuance of circulation registration certificates of drugs and medicinal ingredients of the Ministry of Health agreed to propose the Ministry of Health to grant conditional circulation registration certificates for 03 drugs containing active ingredients. Molnupiravir is indicated for the treatment of COVID-19 by domestic manufacturing facilities.

The Advisory Council for the issuance of circulation registration certificates for drugs and medicinal ingredients of the Ministry of Health proposes the Ministry of Health to grant conditional circulation registration certificates for 3 drugs containing the active ingredient Molnupiravir with indications for the treatment of COVID-19. 

On the evening of January 5, the Ministry of Health had information about the meeting of the Advisory Council for the issuance of circulation registration certificates of drugs and medicinal ingredients of the Ministry of Health about the application for registration of circulation of the drug Molnupiravir.

On December 30, 2021, the National Assembly Standing Committee issued Resolution No. 12/2021/UBTVQH15 allowing the implementation of a number of mechanisms and policies in the health sector to serve epidemic prevention and control. COVID-19.

In particular, the National Assembly Standing Committee has unanimously decided on a mechanism for licensing new drugs with indications for use in the prevention and treatment of COVID-19 domestically produced with the same active ingredients, dosage forms, and routes of administration as those used in drugs. Licensed by the Strict Drug Regulatory Authority (SRA) according to the classification of the World Health Organization.

Based on the new drug licensing mechanism with indications for use in the prevention and treatment of COVID-19 in Resolution No. 12/2021/UBTVQH15,  the Advisory Council issues a certificate of registration for circulation of drugs and medicinal ingredients from the Ministry of Health. has urgently held a meeting on January 5, 2022 to review the application for a certificate of circulation of drugs containing the active ingredient Molnupiravir from domestic manufacturers. 

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 results. The panel agreed to propose the Ministry of Health to grant conditional marketing authorization for 3 drugs containing the active ingredient Molnupiravir with indications for the treatment of COVID-19. 

Specific conditions for strict control of drug quality after being granted circulation registration certificates required by the Council for drug manufacturing establishments are as follows: 

Drug-manufacturing establishments must check the quality of raw materials to meet the requirements before production; 

Drug-manufacturing establishments must continue to monitor and inspect drug quality monthly after being granted a circulation registration certificate  and report to the management agency for strict supervision on the quality and shelf life of the drug;

Manufacturers of drugs must continue to conduct drug stability studies and submit research data and updated expiration 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. 

With regard to the issuance of circulation permits for drugs to treat COVID-19, the Minister of Health requires regulatory agencies and specialized units to strictly control quality and manage prices in accordance with the provisions of the Pharmaceutical Law. , against all negative manifestations, group interests in the supply of drugs.

* Regarding the drug Molnupiravir, the Health and Life newspaper said that up to now, the Ministry of Health has allocated more than 300,000 doses to 51 localities that are implementing the Controlled Drug Program for F0 infected with COVID-19. mild in the community.

Previously, based on the mid-term evaluation results of clinical trial studies conducted at Thong Nhat Hospital, Central Lung Hospital, University of Medicine and Pharmacy, Ho Chi Minh City, showed the safety and effectiveness of Molnupiravir, The Ministry of Health has authorized the implementation of the Controlled Use of Molnupiravir Program for mild COVID-19 cases in the community in Ho Chi Minh City from mid-August 2021.

The results of the mid-term report of the program in 22 provinces/cities showed that Molnupiravir has high safety, good tolerability, obvious effectiveness in reducing viral load, reducing transmission, reducing severe transfer, and shortening the duration of the disease. duration of treatment with the proportion of patients with negative or positive RT-PCR test results after 5 days with CT value ≥ 30 from 72.1% to 99.1%; percentage of patients with RT-PCR test results after 14 days negative or positive with CT value ≥ 30 nearly 100%; the rate of severe transfer was very low from 0.02%-0.06% and no cases resulted in death.

Source: Cổng thông tin điện tử Chính phủ

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