The Ministry of Health has recently submitted to the National Assembly a draft Law amending and supplementing several provisions of the Law on Pharmacy, with a number of important proposals aimed at simplifying administrative procedures, shortening dossier processing times, and improving regulatory efficiency in the pharmaceutical sector.
Accordingly, the draft law is designed to introduce a more comprehensive reform of management processes, significantly reduce unnecessary administrative procedures, and strengthen decentralization and delegation of authority, along with clearly defined responsibilities for each relevant agency and unit. The objective is to create a more favorable environment for individuals and enterprises operating in the pharmaceutical sector.
One notable proposal is the removal of the requirement for certification of drug information content and advertising. This measure is being implemented in accordance with the Prime Minister’s Decision No. 1661/QĐ-TTg on reducing and simplifying regulations related to business activities under the management scope of the Ministry of Health.
In addition, the draft allows pharmaceutical manufacturers and producers of pharmaceutical ingredients to apply appropriate quality management measures in accordance with Good Manufacturing Practice (GMP) principles, in place of certain quality testing procedures. For vaccines and biological products containing antibodies, some testing requirements may also be waived in specific cases. These provisions are expected to shorten testing turnaround times, reduce storage costs, and improve the supply capacity of medicines to the market.
In terms of regulatory management, the draft Law proposes delegating authority to local Departments of Health to revoke drugs in cases where Level 2 and Level 3 substandard medicines are detected within their jurisdiction. At the same time, the issuance of Pharmacy Practice Certificates for clinical pharmacists at healthcare facilities under the Ministry of Public Security and the Ministry of National Defence is also proposed to be decentralized in order to enhance autonomy in professional management.
Regarding the issuance and renewal of marketing authorization for pharmaceuticals, several provisions are being revised toward streamlining application dossiers and shortening processing procedures. In certain cases of renewal, variation, or supplementation of marketing authorization, prior review by an advisory council or approval from the Ministry of Health will no longer be required as before.
Notably, the timeline for publishing dossiers related to variations and supplements has been reduced from 3 months to 15 working days. The time required for issuing marketing authorization for new drugs, vaccines, and biological products with dossiers assessed by stringent regulatory authorities (SRA) has also been shortened from 12 months to 9 months.
In addition, enterprises are still allowed to continue using expired marketing authorizations provided that they have submitted renewal applications in accordance with regulations, until a renewal decision is issued or an official response is received from the Ministry of Health. This provision helps ensure continuous drug supply, reduces the risk of market disruption, and eases administrative cost pressures on enterprises.
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