Applying AI and Big Data to receive and process drug registration applications

AI and Big Data will be applied to receive and process drug registration applications.

In the context of digital transformation being an inevitable trend, the technological revolution is opening up many valuable opportunities for the medical industry, from improving service quality, enhancing the effectiveness of diagnosis and treatment, improving the quality and accessibility of drugs, to patient experiences and satisfaction.

In particular, Resolution 57-NQ/TW of the Politburo on breakthroughs in science and technology development, innovation and national digital transformation is the basis for the medical sector to make breakthroughs in innovation of thinking, promote determination to develop digital healthcare, meet the requirements of people's health care in the new situation, and contribute to the cause of making our country develop strongly in the new era - the era of national development.

Results of handling drug registration applications

Sharing solutions to improve management efficiency and publicize transparency in the pharmaceutical sector - the "source" of drug supply for medical facilities across the country, Deputy Minister Do Xuan Tuyen emphasized that the application of information technology (IT) and digital transformation is an important solution to meet the requirements of administrative reform and improve the quality of service for people and businesses.

The Deputy Minister said that up to now, 100% of drug registration applications have been received and processed online, and businesses do not have to wait to submit paper applications at the one-stop department.

The results of handling drug registration applications are very positive, with online approval increasing every year.

In particular, previously manual operations have been automated, such as: all records are kept and operations are centralized on the online system; minutes are automatically established for each record immediately after review and approval; the system automatically returns to experts if different opinions are detected; all subcommittees are simultaneously appraised; the system automatically creates official dispatches based on opinions proposed by experts; sample labels, instructions for use, and drug quality standards have been published on the online system; information on approval of circulation registration certificates is continuously updated on the online public service system immediately after each approval of changes, additions, or corrections at the Public Service System of the Department of Drug Administration.

The demand for drugs for medical examination and treatment at medical facilities is very large - Photo: VGP/HM

According to a representative of the Drug Administration of Vietnam, Ministry of Health, since July 2023, the Department has received and processed all procedures related to online drug registration dossiers. The professional operations of officers and specialists are completely carried out in the electronic environment, from the stages of receiving, classifying, reviewing and processing to the appraisal of dossiers by specialized subcommittees.

Previously, each file took a lot of time to arrange, classify manually and transport to different units in Hanoi and Ho Chi Minh City, causing difficulties in tracing processing status or risk of losing files.

However, since the implementation of the online system, the drug registration dossier has been greatly reduced in terms of intermediate administrative steps such as arranging, classifying and transporting dossiers. Specialized subcommittees can simultaneously appraise, regardless of the appraisal progress of other subcommittees.

Once the council's assessment results are available, the Drug Administration will issue a decision to grant or extend the circulation registration certificate, announce the ingredients, label samples, drug instructions and drug quality standards, all of which are performed entirely on the online public service system.

According to the Drug Administration of Vietnam, in the first 11 months of 2024, this unit has granted and extended more than 12,300 drugs, nearly equal to the total number of drugs that have been granted and extended their circulation registration certificates in the last 5 years combined (in 2019, 3,695 drugs were extended; in 2020, 1,341 drugs; in 2021, 1,230 drugs; in 2022, 2,721 drugs; and in 2023, 4,592 drugs).

Identifying difficulties

However, according to Deputy Minister Do Xuan Tuyen, the process of implementing digital transformation in the pharmaceutical sector still faces some difficulties and obstacles. That is, the number of applications received is increasing, while the human resources for processing applications have not been supplemented in time.

The procedures and processes in the field of drug registration are complex, meticulous, and require many processing steps. Changing the mindset of processing paper records to operating in an electronic environment also requires efforts to change from many sides. Drug registration records have a large capacity, leading to a very rapid growth in the storage space of the online system server.

Adequate and timely supply of medicines and supplies will greatly determine the outcome of patient treatment - Photo: VGP/HM

At the recent discussion between the Prime Minister and European businesses, Mr. Burak Pekmezci, General Director of Sanofi Vietnam - representing businesses in the pharmaceutical industry, also said that digital transformation is an inevitable trend according to the national strategy. Vietnam's pharmaceutical industry has also begun to apply technology with the entire drug registration process being carried out online.

However, this process has only stopped at digitalization – that is, converting from paper records to online storage, data evaluation and information exchange. True digital transformation requires leveraging artificial intelligence (AI) and cloud computing to improve the quality of state management of pharmaceuticals, thereby improving the quality, safety and effectiveness of drugs.

This also helps to make the licensing process more transparent, shorten registration times and reduce resource pressures, thereby improving access to medicines.

Application of AI in drug registration dossier appraisal

Along with the above viewpoint, the leader of the Ministry of Health said that the Ministry will continue to have solutions to overcome this problem. That is to promote digital transformation, coordinate with relevant units to research and apply artificial intelligence (AI), and process big data to improve the effectiveness and efficiency in the process of receiving and processing drug registration dossiers.

At the same time, coordinate with relevant units to maintain, adjust, upgrade and perfect the online system to better serve people and businesses.

In particular, after the Law amending and supplementing a number of articles of the Law on Pharmacy takes effect (from July 1), the Department of Drug Administration will continue to adjust the online public service system to implement the automatic renewal mechanism. Renewal registration dossiers will be made public on the system, ensuring that businesses can continue to use the circulation registration certificate.

In addition, the Drug Administration of Vietnam will deploy AI applications in the appraisal of drug registration dossiers with the goal of completely replacing manual dossier receipt when receiving dossiers at the one-stop department, overcoming the situation of queuing and waiting for businesses; building a system to detect and warn of fake dossiers, inaccurate information and inconsistencies between submitted dossiers.

At the same time, support the review and legal assessment of drug registration dossiers, thereby reducing the time for legal assessment for specialists and experts. Integrate accompanying utilities such as chatbot systems and automatic answering virtual assistants, allowing businesses to query information and receive quick and effective answers...

To synchronously implement regulations when the Law amending and supplementing a number of articles of the Pharmacy Law officially takes effect, businesses and organizations recommend that management agencies should promptly issue guiding regulations and ensure effectiveness in implementation.

Hien Minh