Ministry of Health announced extension of nearly 8,900 types of drugs and pharmaceutical ingredients

Information from the Ministry of Health, on February 8, Director of the Department of Drug Administration Vu Tuan Cuong signed Decision No. 62 promulgating the list of drugs and pharmaceutical ingredients with circulation registration certificates that can continue to be used according to the provisions of Clause 1, Article 3 of Resolution No. 80/2023/QH15 dated January 9, 2023 of the National Assembly (Phase 1).

In this list, nearly 8,900 types of drugs, pharmaceutical ingredients,VaccineBiological products with circulation registration certificates may continue to be used from the date of expiration until December 31, 2024.

This list includes 3 groups: 6,819 domestically produced drugs and pharmaceutical ingredients; 1,856 foreign-produced drugs and pharmaceutical ingredients; and 203 types of vaccines and biological products.

The drugs and pharmaceutical ingredients announced this time include drugs to treat common diseases and specialized diseases such as cardiovascular, digestive, diabetes, musculoskeletal, respiratory, infectious, cancer...

The Ministry of Health announced the extension of nearly 8,900 types of drugs and pharmaceutical ingredients. Photo courtesy of Thanh Chung

In 2022, implementing Resolution No. 12/2021 of the National Assembly Standing Committee and Resolution 29/2022 of the Government, the Ministry of Health announced that more than 10,300 drugs will continue to use their registration certificates until December 31, 2022.

In early December 2022, the Ministry of Health issued a Summary Report on the implementation of extending drug circulation registration certificates according to the 2016 Pharmacy Law, in the face of a situation where more than 9,000 registration certificates (accounting for 40% of the number of drugs on the market) expired by December 31, 2022, meaning they cannot be circulated from January 1, 2023 due to not being extended.

At the same time, according to the Ministry of Health's calculations, in 2023, 3,802 more drug registration certificates will expire. This leads to a very large number of applications for drug registration renewal that must be processed from the end of 2022 to the end of 2023 (nearly 14,000 drugs), causing a risk of serious drug shortages if not handled promptly. The Ministry of Health also stated that if not renewed in time, pharmaceutical companies will have to stop production and business, and workers will lose their jobs.

Meanwhile, the renewal procedure according to current regulations is still very slow and does not meet practical needs; the department's human resources are "overloaded" when it has to process thousands of applications a year.

"It is expected that the department will only be able to process about 500 extension applications per month, and a maximum of about 6,000 applications per year," the Ministry of Health's report stated.

According to the current Pharmaceutical Law, drugs that want to be legally circulated on the market must be registered by the enterprise - this is a mandatory condition. The certificate issued by the Ministry of Health is valid for 5 or 3 years. Within 12 months before the certificate expires, the registration facility must submit an application to renew the certificate, otherwise it must stop supplying that type of drug./.