According to Mr. Chu Dang Trung, Head of the Legal and Integration Department of the Drug Administration of Vietnam ( Ministry of Health ), more than 7 years of implementing the decrees guiding the implementation of the Law on Pharmaceuticals have revealed some shortcomings and limitations in state management as well as difficulties and obstacles for businesses.
Speaking at the "Workshop to gather feedback from businesses on the draft Decree guiding the amendment and supplementation of some articles of the Law on Pharmaceuticals" on February 18th, Mr. Chu Dang Trung - Head of the Legal and Integration Department, Drug Administration of Vietnam (Ministry of Health ) said that Law on Pharmaceuticals No. 105/2016/QH13 was passed by the 13th National Assembly on April 6, 2016, and came into effect on January 1, 2017.
Based on that, the Government issued Decree No. 54/2017/ND-CP detailing some provisions and measures for the implementation of the Law on Pharmaceuticals on May 8, 2017; and Decree No. 155/2018/ND-CP amending and supplementing some regulations related to investment and business conditions under the state management scope of the Ministry of Health, issued by the Government on November 12, 2018. In 2023, the Government also issued Decree No. 88/2023/ND-CP amending and supplementing some articles of the two aforementioned decrees.
However, after more than 7 years of implementation, the decrees guiding the implementation of the Pharmaceutical Law have revealed some shortcomings and limitations in state management, as well as difficulties and obstacles for businesses and organizations in their implementation.
Accordingly, the decrees do not yet contain specific regulations on the corresponding professional practice content at the pharmaceutical practice certification facilities. The current regulations also create difficulties with regard to regulations on the control of special drugs.
For example, the procedures for importing drugs that require special control have not been simplified. Regulations regarding the reporting of import, export, inventory, and use of toxic drugs and toxic raw materials used in pharmaceuticals are not consistent with drug management...
"To address these shortcomings, the draft Decree guiding the amendment and supplementation of some articles of the Law on Pharmaceuticals has been developed to provide detailed regulations on some articles and measures for the implementation of the Law on Pharmaceuticals. These amendments will promptly resolve the difficulties and obstacles stipulated in the previous decree guiding the implementation of the Law on Pharmaceuticals," Mr. Trung said.
Mr. Dau Anh Tuan, Deputy Secretary General and Head of the Legal Department of the Vietnam Chamber of Commerce and Industry (VCCI), stated that the pharmaceutical industry not only plays a crucial role in protecting and caring for people's health but is also an economic sector with strong development potential. Building a suitable, transparent, and effective pharmaceutical legal system will create favorable conditions for businesses to produce and trade, while ensuring drug quality and public health safety.
Over the past period, the Law on Pharmaceuticals and its implementing regulations have contributed to the development of Vietnam's pharmaceutical industry towards professionalism and modernization, enhancing the capacity for production, management, and quality control of pharmaceuticals.
However, in order to facilitate businesses in the production, trading, and import/export of pharmaceuticals; and to enhance transparency and simplify administrative procedures in the pharmaceutical sector, it is necessary to draft a Decree guiding the amendment and supplementation of certain articles of the Law on Pharmaceuticals in accordance with the actual situation.
"The draft decree needs to be updated and supplemented with regulations that are consistent with reality in order to address shortcomings in licensing, registration for circulation, price management of drugs, control of specially controlled drugs, medicinal herbs, excipients, capsule shells, and to ensure the supply of drugs in the context of epidemics and natural disasters."
"At the same time, it is necessary to strengthen international integration, access advanced pharmaceutical management standards, and harmonize with international commitments to which Vietnam is a member," Mr. Anh Tuan emphasized.
Ha Anh
Source: https://doanhnghiepvn.vn/kinh-te/chinh-sach/go-kho-cho-doanh-nghiep-duoc/20250218030230717
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