Among the amendments, the revised law introduces changes to Article 56 of the current law concerning the authority, documentation, procedures, and timelines for issuing, renewing, amending, or supplementing licenses for drug registration and raw materials serving drug production. Specifically, the validity period for drug registration licenses is set at five years from the date of issuance or renewal, except in certain cases. For drugs requiring ongoing safety and efficacy monitoring, the validity period is three years.
Earlier, Nguyen Thuy Anh, Chairwoman of the NA Committee for Social Affairs, presented a report on the draft of the freshly adopted law.
She stated that in response to feedback from deputies, the NA Standing Committee directed the inclusion of provisions to control the number of registration licenses for drugs with identical active ingredients and raw materials, aligning with socioeconomic conditions over time as well as to prioritise investment in IT infrastructure and digital transformation in pharmaceutical activities.
Regarding preferential policies and investment support in the pharmaceutical industry, based on the majority opinion of deputies, the NA Standing Committee agreed with the Government’s proposal to apply special investment incentives for new projects in the pharmaceutical field with a total investment capital of at least 3 trillion VND (118.02 million USD). These projects must disburse a minimum of 1 trillion VND within three years from the date of investment registration certificate issuance or investment policy approval.
On drug price management, the NA Standing Committee reviewed and concurred with the Government’s proposal to implement measures for publishing projected wholesale prices for prescription drugs.
