What does the Drug Administration say about delays in granting and renewing registration numbers leading to drug shortages?

The conclusions of the Government Inspectorate, recently announced, show that during the inspection period, there were delays in processing applications for granting and renewing registration numbers for drugs and medical equipment at the Ministry of Health, which was one of the reasons for the shortage of drugs and equipment.

Paper documents for registering a drug are submitted to the Drug Administration Department. According to the department, the delay in implementing information technology in the process of receiving, tracking, and notifying the issuance of drug registration dossiers was a major shortcoming before 2022. - Photo: Ministry of Health

This issue has drawn attention because recently the hospital has been lacking many medicines and medical equipment, patients have to wait for examinations and treatment, and incur costs to purchase medicines and medical supplies outside the hospital even though those medicines and supplies are covered by health insurance.

On December 11-12, the Director of the Drug Administration Department, Vu Tuan Cuong, and the Deputy Director, Nguyen Thanh Lam, met with the press to provide information on existing problems and proposed solutions. Mr. Lam said:

There are many subjective and objective reasons leading to the drug shortage. The market currently has over 24,000 drug registration numbers, with over 13,000 new and renewed registrations expected in 2024 alone. This is also the time when we are focusing our efforts on drafting the revised Law on Pharmaceuticals (amending nearly 50 articles). The inspection results relate to a whole period, including the period from 2019 to 2022.

At that time, the mistakes in the VN Pharma case affected the morale of many people. As many as 36 members of the expert group stopped participating in the evaluation of drug registration dossiers, and 4 subcommittees lacked experts to review the dossiers, leading to a backlog. Simultaneously, 36 civil servants of the department resigned, and the COVID-19 pandemic further hampered the dossier evaluation process.

This, coupled with the fact that over 20,000 drug registrations represent over 20,000 sets of documents, not including supplementary documents, all in paper form, is problematic. Each time we send documents to experts for review, we hand over a large number of file folders to the courier; some drug dossiers contain up to 149 paper files. The inspection report requires the Drug Administration Department to immediately address the lax management, specifically the management and monitoring of dossiers. The failure to effectively implement information technology at this stage is a major shortcoming, leading to insufficient conditions for dossier monitoring, but it does not constitute a laxity in state management.

Mr. Nguyen Van Loi, head of the Drug Registration Department of the Drug Administration, introduces the current system for receiving and tracking drug registration applications - Photo: THUY ANH

Viettimes : How do you explain the situation where businesses have to submit additional documents multiple times, with some businesses submitting them 6-7 times, or receiving multiple requests for the same additional information?

The current drug registration dossier is jointly implemented by 10 ASEAN countries. Regarding the percentage of dossiers requiring supplementary documents, we have reported to the Government that 94% of initially submitted dossiers require supplementary documents due to insufficient quality. However, these requests are not made arbitrarily by the agency but by experts. There have also been cases requiring supplementary documents 6-7 times, but according to the upcoming amendment to the Pharmaceutical Law, businesses will only be allowed to supplement documents 3 times, which is also a regulation to help improve the quality of submitted dossiers.

Regarding the fact that businesses receive many requests for additional information that are identical, this is due to the overlap between the two relevant documents concerning drug pricing. When the department receives the drug price declaration dossier, the business is allowed to sell the drug. This request for additional information is an administrative requirement but does not affect the business's sales. The department has already provided an explanation on this matter.

Tuoi Tre Newspaper: Regarding the processing of drug registration applications, some businesses say that this has been done faster recently, but they need to be able to track the status of their applications and the current processing stage. The "one-stop" application submission system has also been criticized for being difficult to log in to...

When the system first became fully operational (it has been fully operational since July 2023), there were some glitches, but it now runs smoothly. Businesses can submit all documents through the system, and both the department and the business can track the progress of the process. However, businesses will not be able to view some information, such as which expert is currently reviewing the document.

Which part of the department is lagging, and to what extent, is clearly displayed, allowing for monitoring, follow-up, and accountability measures.

Viettimes: What are the solutions you've proposed to address the existing errors?

The Drug Administration Department has twice implemented an information technology system for drug registration, but both attempts failed, requiring a complete overhaul. With the new system, we have dedicated significant time to its organization, and now businesses no longer need to submit paper documents; council meetings are also held online.

Regarding the review of applications, previously the advisory council for granting registration numbers held meetings every two months, but from 2020 to the present, the average has been 30 meetings per year, and in 2023-2024 alone, it reached 44 meetings per year. Previously, independent experts were invited from only two medical universities; now, experts from six universities are invited, totaling 600 experts. The drug registration department has added 25 staff members, simultaneously with the completion of the legal framework.

As a result of these changes, the number of drug registrations and renewals granted has increased over the years: 1,341 drugs in 2021, 2,721 drugs in 2022, 4,592 drugs in 2023, and 13,164 drugs in the first 11 months of 2024, equivalent to the total number granted in the previous 5 years combined.

Tuoi Tre Newspaper: As you mentioned, there are plenty of medicines, but many hospitals are experiencing shortages. What is the reason for this?

Our survey revealed that hospitals like the National Children's Hospital, Hue Central Hospital, and Cho Ray Hospital... do not lack medicine, but why are some hospitals experiencing shortages? There is a delay in procurement. If pharmacies have the medicine but the hospital doesn't, it's because the hospital is slow in purchasing and bidding.

Speaking to Tuoi Tre newspaper on the morning of December 11th, a representative of a company specializing in importing pharmaceuticals said that compared to previous years, the process of granting drug registration numbers at the Drug Administration Department is now faster. This is something the company has been hoping for to ensure the supply of medicines and its production and business activities.

However, this representative suggested that during the drug registration process, businesses need to know the status of their application, the current stage of processing, and receive prompt feedback from the agency on whether the application is approved or not, and what additional information is needed, in a quick and efficient manner, avoiding the practice of "delaying" applications for years as the Government Inspectorate has pointed out.

Source: https://tuoitre.vn/cuc-quan-ly-duoc-noi-gi-ve-cham-tre-cap-gia-han-so-dang-ky-dan-den-thieu-thuoc-20241211182121534.htm