Action plan of National strategy for Vietnam’s pharmaceutical industry development of the Ministry of Health of Vietnam

Action plan of National strategy for Vietnam’s pharmaceutical industry development of the Ministry of Health of Vietnam (Internet image) 

Regarding this issue, LawNet would like to answer as follows:

On February 20, 2024, the Minister of Health issued Decision 388/QD-BYT on action plan of National strategy for Vietnam's pharmaceutical industry development period to 2030 and vision to 2045, according to Decision 1165/QD-TTg in 2023.

Action plan of National strategy for Vietnam’s pharmaceutical industry development of the Ministry of Health of Vietnam

The implementation of this Plan will be demonstrated through the following contents:

(1) Direction and administration work

- Organize Strategy Implementation Conference

- Establishment of a Steering Committee to implement the Strategy

- Annual report on Strategy implementation results

- Organize preliminary reviews to evaluate the progress and results of implementing the Strategy

(2) Developing and implementing mechanisms, policies, and laws on Pharmacy

- Amending and supplementing the Pharmacy Law

- Develop legal documents detailing the implementation of the amended and supplemented Pharmacy Law (if approved).

- Review, amend, and supplement the list of essential drugs.

- Develop regulations related to granting circulation registration certificates for generic drugs whose patents are about to expire, the first similar biological products, rare drugs, and vaccines that have been pre-evaluated by the World Health Organization.

- Develop a roadmap for improving good practice standards (GPs) for drug production and business activities; Implement PIC/S-GMP standards or equivalent in drug production in accordance with international integration trends; encourage the implementation of EU-GMP; Research and participate in the PIC/S Pharmaceutical Inspection Cooperation System.

- Develop reasonable import policies, consistent with international treaties to which Vietnam is a member.

(3) Improving capacity to manage and control the market for drugs and medicinal ingredients

- Project to improve pharmaceutical inspection capacity.

- Plan to inspect, test, and monitor the quality of drugs circulating on the market.

- Striving to achieve WHO level 3 or higher certification on the capacity of state management agencies for pharmaceutical chemicals,
Maintain and improve WHO's certification of the capacity of state management agencies for vaccines.

- Investment project to strengthen the capacity of the drug testing system.

- Investment project to strengthen the capacity of the Vaccine and Biological Products Inspection System.

- Project to implement the planning of a testing system for drugs and medicinal ingredients

(4) Developing and carrying out scientific research and training projects and topics

- Plan for in-depth training of high-quality pharmaceutical human resources in the fields of clinical, research, and production of drugs and medicinal ingredients.

- Research topics and projects applying advanced and modern drug preparation technology.

- Plan for technology transfer, production, and processing of patented patent medicines, vaccines, medical biological products, and drugs that cannot be produced in Vietnam, with priority given to the development of patent medicines from endemic medicinal herbs.

- Guidance on implementing science and technology tasks at national and ministerial levels using the state budget to develop the domestic pharmaceutical industry

- Managing the implementation of research projects and the transfer of technology for preparing high-tech medicinal products

(5) Conducting clinical pharmacy activities and using safe and effective drugs at reasonable prices

- Develop documents to guide good drug prescribing practices.

- Circular amending and supplementing regulations on good pharmacy practices and strengthening implementation.

- Circular amending or developing new circulars and instructions on pharmacovigilance activities, drug information, and drug advertising.

- Develop clinical pharmacy training programs and documents to meet industry development requirements.

- Circular amending and supplementing regulations on the organization and operation of clinical pharmacy in medical examination and treatment facilities.

- Project to strengthen clinical pharmacist training.

(6) Development of medicinal materials, medicinal drugs, and traditional drugs

- Comprehensive program to develop and promote medicinal potential.

- Project deploys 08 sustainable exploitation areas of natural medicinal herbs.

- Plan to restore, import, acclimatize, and develop 10-15 species of medicinal plants originating from large quantities of imports

- National product research and development project for drugs from medicinal herbs.

- Research project to build a database of reference substances/standard substances, standard medicinal herbs, reference medicinal herbs, high standards, and endemic medicinal herbs standards of Vietnam.

(7) Promoting domestic drug use

- Issue circular amending and supplementing the Circular regulating drug bidding at public medical facilities, including regulations to increase the proportion of domestically produced drugs, incentives for domestically produced drugs, and appropriate procurement mechanisms for domestically produced patent drugs and technology-transferred drugs.

 - Communicate about the quality, safety, effectiveness, and reasonable prices of domestically produced drugs and provide information about the origin and effects of medicinal herbs, especially endemic Vietnamese medicinal herbs.

- Continue to organize and effectively conduct the campaign "Vietnamese nationals prioritize Vietnamese medicine.".

(8) Digital transformation to modernize the pharmaceutical industry

- Complete the digitalization of the pharmaceutical industry, build a drug database for pharmaceutical management and business activities.

- Complete construction of the national pharmaceutical database.

- Successful application of digital technologies: AI, big data, IoM, Blockchain,... in the field of pharmaceuticals and cosmetics

More details can be found in Decision 388/QD-BYT, taking effect on February 20, 2024.

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