Tighten regulations and improve the quality and safety of medicines.

The Ministry of Health is currently amending and supplementing Circular No. 30/2025/TT-BYT dated July 1, 2025, to improve the legal framework for drug testing, meeting the increasingly high demands for quality, safety, and treatment efficacy. These efforts aim to enhance the capacity of the pharmaceutical management system and prevent the risk of substandard drugs.

Quality testing of active ingredients used in drug manufacturing at the Central Institute for Drug Testing.

According to Deputy Minister of Health Nguyen Tri Thuc, immediately upon its entry into force, Circular No. 30/2025/TT-BYT dated July 1, 2025 (Circular No. 30) has played a fundamental role in guiding the application of quality standards, testing of drugs and drug raw materials, and handling of drug violations.

However, after a period of implementation, some provisions of this circular have revealed shortcomings and limitations. One of the major problems is the lack of clarity in the regulations regarding supplementary sampling, leading to inconsistent interpretations and applications among localities.

Many Departments of Health have reported that in some cases, businesses have failed to collect additional samples as required; however, the penalties for violations are not strong enough, hindering post-inspection work. Furthermore, regulations regarding the handling of substandard drugs based on the sampling location are not yet suitable for the practical realities of drug distribution.

The supply chain for pharmaceuticals, if based solely on the sampling location for processing, risks overlooking violations or failing to thoroughly address them throughout the system. Another point to note is the lack of uniformity in the process of recalling and destroying substandard drugs. The responsibilities between regulatory agencies and businesses at each stage are not clearly defined, leading to prolonged recalls and increasing the risk of substandard drugs continuing to circulate.

Notably, while Vietnam is striving to meet the World Health Organization's standards for national drug and vaccine regulatory systems (NRA), some provisions of the Circular do not fully align with international requirements, particularly regarding post-marketing surveillance mechanisms and early warning systems for potential safety risks.

In response to the aforementioned shortcomings, the Ministry of Health is currently seeking feedback and drafting amendments to Circular No. 30. This is a timely step, demonstrating a practical approach to management.

Accordingly, the main amendments to the Circular focus on the recall and handling of substandard drugs; regulations on drug destruction; mechanisms for temporarily suspending the business and use of drugs showing signs of being unsafe; and the responsibilities of manufacturing and importing establishments when carrying out voluntary recalls.

Dr. Vu Tuan Cuong, Director of the Drug Administration Department (Ministry of Health), stated: First of all, supplementing and clarifying concepts and terminology will help unify understanding and application throughout the entire system.

This is an urgent requirement in the context of the ongoing adjustment and updating of relevant legal regulations in the pharmaceutical sector. Notably, the draft amendment aims to tighten the supplementary sampling process by clearly defining the responsibilities of manufacturers and importers in fulfilling sampling requirements when there is suspicion of quality issues; and also adding penalties for non-compliance.

In the post-inspection phase, the amendments focus on standardizing the drug recall process, including both voluntary and mandatory recalls. More specific regulations on the procedures, responsibilities, and scope of recalls will help ensure that infringing drugs are quickly removed from the market, minimizing the risk to patients. Notably, a key new point in Circular No. 30 is the addition of regulations on temporarily suspending business, sealing, and storing drugs showing signs of being unsafe. This is considered a breakthrough mechanism in management, allowing authorities to intervene promptly before the final test results are available.

Deputy Minister Nguyen Tri Thuc emphasized that one of the important directions in adjusting, amending, and supplementing Circular No. 30 is to ensure compliance with the recommendations of the World Health Organization, especially regarding the National Regulatory Authority (NRA). This is an international standard for assessing the pharmaceutical management capacity of each country, in which the testing system plays a key role.

The addition of regulations requiring pre-market testing is considered a significant step forward, contributing to early detection of risks, instead of only addressing issues after drugs have entered the market. Along with this, the process for recalling and handling infringing drugs is also proposed to be standardized in a transparent manner, with clear responsibilities and shorter processing times.

This indicates increasing pressure on quality control, requiring a robust legal framework. Revising regulations to strengthen post-inspection, clarify responsibilities, and add flexible management tools will contribute to improving the capacity of the entire testing system from the central to local levels.

The completion of Circular No. 30 not only helps to overcome existing shortcomings but also creates a solid legal foundation for controlling drug quality in the context of an increasingly developing, diverse, and potentially risky pharmaceutical market. The ultimate goal of the revision is not only to improve the document but also to minimize risks for patients, enhance treatment effectiveness, and strengthen public trust in the healthcare system in protecting people's health.

THANH MAI

Source: https://nhandan.vn/siet-chat-quy-dinh-nang-cao-chat-luong-an-toan-thuoc-post961176.html