Nearly 800 more drugs for medical examination and treatment

The Ministry of Health has just extended and announced nearly 800 more pharmaceutical products, including conventional and bioequivalent drugs, to serve the needs of medical examination, treatment and epidemic prevention.

Of the nearly 800 types of drugs that were extended this time, 730 were extended according to the provisions of the 2016 Pharmacy Law and 35 drugs with proven bioequivalence were announced.

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Of the 730 drugs extended this time, 453 drugs were extended for 5 years; 219 drugs were extended for 3 years and 58 drugs were extended until December 31, 2025.

It is known that the pharmaceutical products whose circulation registration certificates have been extended this time are all domestically produced drugs, quite diverse in pharmacological groups including drugs for treating cardiovascular diseases, hypertension, diabetes, cancer treatment, antiviral drugs, drugs for treating respiratory diseases, antibiotics, antipyretics, analgesics, and other common anti-inflammatory drugs....

It is known that in August 2024, the Department of Drug Administration continuously extended and re-issued registration certificates for drugs, vaccines and medical biological products according to the Law on Pharmacy.

In the most recent batch, about 10 days ago, there were nearly 900 pharmaceutical products, including original pharmaceuticals, vaccines, and medical biological products, of which the list of original pharmaceuticals included 30 types, the list of domestically produced drugs included nearly 400 types, and the rest were foreign drugs.

These include new drugs, vaccines and medical biological products that are granted with renewals for 5 years, 3 years and until December 31, 2025.

In addition, the Drug Administration also extended the drug circulation registration certificate according to Resolution 80 of the National Assembly.

The recent shortage of medicines is largely related to the issuance of new licenses and renewal of registrations for drugs and pharmaceutical ingredients.

Therefore, according to the representative of the Ministry of Health, the draft revised Law on Pharmacy has simplified the dossier for renewal, change, and supplement of registration certificates for circulation of drugs and pharmaceutical ingredients. It has streamlined administrative procedures, reduced the time for renewal and issuance of registration certificates for circulation of drugs and pharmaceutical ingredients.

Regarding the dossier, order and procedures for extending the validity of the circulation registration certificate for drugs and pharmaceutical ingredients: Clause 1, Article 56 of the 2016 Pharmacy Law stipulates that all drugs after the expiration of the Circulation Registration Certificate must re-submit the renewal dossier and these dossiers must go through the appraisal and approval process of the Advisory Council for the issuance of the Circulation Registration Certificate. This provision of the Pharmacy Law has contributed to the management of drugs with quality, safety and effectiveness.

However, the regulation is only suitable for drugs in circulation that have quality or safety problems that need to be re-evaluated before extending the validity of the circulation registration certificate.

In addition, in the draft revised Law on Pharmacy, the drafting committee proposed to stipulate cases of extension, change, and supplementation of the Circulation Registration Certificate that do not have to go through the Advisory Council for granting Circulation Registration Certificates for drugs and pharmaceutical ingredients or do not have to be approved.

Reduce the time to process records from 3 months to 15 working days for records of changes and additions that only need to be announced.

Supplementing regulations allowing establishments to continue using the circulation registration certificate after it expires and has submitted an application for renewal according to regulations until it is renewed or has a document from the Ministry of Health.

Supplementing regulations allowing the replacement of CPP (Certificate of Pharmaceutical Product) with legal documents proving that the drug is licensed in cases where it meets the needs of disease prevention and control...

Source: https://baodautu.vn/them-gan-800-loai-thuoc-phuc-vu-kham-chua-benh-d223233.html