Topics Opinion Exchange Meeting with Mr. Dao Hong Lan, Minister of Health of Vietnam" was held.

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From July 3 to 7, 2023, eight members of the Vietnamese Ministry of Health, including the Vietnamese Minister of Health, visited Japan. They visited the Ministry of Health, Labour and Welfare, the Pharmaceuticals and Medical Devices Agency (PMDA), the National Center for Global Health and Medicine, etc. On the last day of their visit, a forum was set up for dialogue with Japanese pharmaceutical companies. Companies belonging to the Asia Subcommittee of the JPMA International Affairs Committee exchanged views with the Minister of Health and the Director General of the Drug Administration Bureau. The companies frankly expressed the pharmaceutical issues they are facing, and the Vietnamese authorities introduced the revision of the Pharmaceutical Affairs Law and their efforts to resolve the issues. In addition, Japanese companies introduced projects that contribute to Vietnamese healthcare and requested cooperation for the development of the Vietnamese healthcare industry. As the 50th anniversary of the establishment of diplomatic relations between Japan and Vietnam marks, there are high expectations for cooperation in the healthcare field as the relationship between the two countries continues to strengthen.

This meeting to exchange opinions was initiated by Mr. Noriaki Shorin, Policy Advisor to the Vietnamese Ministry of Health, an expert from the Japan International Cooperation Agency (JICA) who accompanied the delegation, and was supported by the Office of International Pharmaceutical Regulations of the Ministry of Health, Labour and Welfare. Vietnam is currently preparing a bill to revise its Pharmaceutical Affairs Law, which is expected to be approved by the National Assembly in 2024. In revising the law, Vietnam is adopting international practices, improving approval review procedures, and addressing issues faced under the current law. In addition, as part of our plans for the future development of the pharmaceutical industry, we are considering the overseas expansion of domestic companies and the investment in and attraction of foreign companies to Vietnam, and we are trying to obtain information widely from overseas.

The JPMA's Asia Subcommittee has been making recommendations and submitting written opinions to the authorities of various countries in order to promote international harmonization of pharmaceutical regulations and to improve the efficiency, transparency, and predictability of regulatory examinations. As for Vietnam, there have been many pharmaceutical difficulties in the past few years, and we have been working on draft regulations and submitting written opinions. This event provided a very good opportunity for companies to exchange opinions directly with the Vietnamese pharmaceutical regulatory authorities on pharmaceutical issues and laws that they are facing.

On the day of the meeting, the JPMA welcomed a delegation from the Vietnamese Ministry of Health, including Mr. Dao Hong Lan, Minister of Health, and Mr. Vu Toan Kwong, Director of the Drug Administration Department, as well as 11 interpreters from the Japanese side, including five members of the JPMA's Board of Directors, headed by Mr. Kenshi Kinoshita, Chairman of the JPMA's International Affairs Committee, and 16 members of the Asian Subcommittee, led by Mr. Nobuo Murakami, Chairman of the JPMA's International Affairs Committee. The Japanese side was led by Mr. Nobuo Murakami, Chairman of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ).

After opening remarks by Chairperson Kinoshita and Vietnam's Minister of Health, Sachiko Nakagawa, Executive Director of the JPMA, and an introduction of the activities of the JPMA and the Asian Affairs Committee by Osamu Kagawa, Chairperson of the Asian Affairs Committee, the activities of the Vietnamese team were introduced, and the main topic of discussion, issues and requests, was discussed by the JPMA International Affairs Committee's Asian Affairs Division Chairman, Masayo Higashiyama. The main topic of the meeting was the discussion on issues and requests.

Below are some of the topics taken up as issues and requests.

Review and Simplification of the Registration Renewal System

There are several regulatory issues facing companies supplying pharmaceutical products to Vietnam, but one that has plagued companies for the past several years is the fact that regulatory procedures are not processed within the stipulated timeframe, resulting in significant delays. One of the most serious problems is the registration renewal process. Companies have struggled with the uncertainty of having their registration certificates expire while waiting for the review, and how to avoid missing products. Since the renewal of registration and its review period is stipulated in the Pharmaceutical Law, we requested that the system be revised to be effective and operational in the revision of the Pharmaceutical Law that is currently underway.

Mr. Vu Toan Kwong, Director General of the Vietnam Drug Administration, replied that the registration renewal system is being worked on in the preparation of the draft amendment to the Pharmaceutical Law, and that he hopes that we will provide our opinions when the amendment bill is released to the public. He also included in his explanation that the Vietnamese Ministry of Health has sent a delegation to Switzerland and Japan to observe the procedures of these authorities, and that there is consideration to make procedures unnecessary for those products that have already been in circulation in Vietnam for 5 or 10 years and whose safety has been confirmed.

Expediting and streamlining the examination period

It is not uncommon for new drug applications in Vietnam to wait three or four years for review results. The large drug lag is a disadvantage for Vietnamese patients, and for companies, the unpredictable and unpredictable review period can make them hesitant to enter the market. Change applications also take time, to the detriment of both companies and patients. We requested that the Government of Japan consider drastic measures to speed up and streamline the examination process, such as the promotion and effective use of digital technology, the introduction of a formal consultation system and a simplified examination system, and the establishment of an examination center, including an increase in the fee for examination.

Mr. Vu Toan Kwon acknowledged that there are indeed delays in the review of new drugs, and explained the measures planned or underway: four review centers have been established in cooperation with six universities, and the review is gradually being shifted to the centers. Regarding the cost of examination, we learned about the examination fees in Japan during our visit to the Japanese department in charge of examination. Although Vietnam has recently raised its examination fees slightly, it is difficult to set higher fees due to government policy. As for the official consultation system, it is under consideration that the Corporate Support and Training Center established under the guidance of the Minister will have an official consultation function. We are currently coordinating with PMDA in this direction. One of the reasons for the delay in review in Vietnam is the incompleteness of application materials, and 95% of the applications are returned. Regarding the online application screening, he introduced that the online application has been in operation since May 4, 2023, and that companies can check the progress of the screening through their accounts.

Requests from Vietnamese Authorities

The Vietnamese side expressed their desire to discuss the export of pharmaceuticals produced in Vietnam to Japan and the establishment of a system that would enable production in Vietnam in the future. Japanese companies are expected to invest in Vietnam in the pharmaceutical field, and preferential policies to attract them will be considered.

Initiatives by Japanese pharmaceutical companies in Vietnam

In addition to supplying pharmaceuticals, Japanese companies' activities to contribute to Vietnamese healthcare and patients in various ways were also introduced.

Ms. Jyunmi Maruyama (Sumitomo Pharma), a member of the Global Health Subcommittee of the JPMA International Affairs Committee, introduced Sumitomo Pharma's efforts to promote the proper use of antimicrobial agents and contribute to the fight against drug resistance, and introduced the drug sensitivity surveillance study being conducted at major hospital facilities in Vietnam from 2019 Based on the data obtained from the study, we are working on capacity building in the treatment of infectious diseases to enable evidence-based selection and use of antimicrobial agents. the second drug susceptibility surveillance study was launched in February 2023 with the permission of the Vietnamese Ministry of Health. The ceremony to launch the study was held in Hanoi, Vietnam to commemorate the 50th anniversary of the establishment of diplomatic relations between Japan and Vietnam.

Mr. Maruyama introduced the project for promoting proper use of medicines using medication support tools through clinical pharmacists in Vietnam as an initiative of the Access Group of the Global Health Subcommittee of the JPMA International Affairs Committee.For three years from FY2019 to FY2021, the Access Group, in collaboration with the National Center for Global Medical Research (NCGM) Pharmacy Department and the Council for Proper Use of Drugs, Inc. Medical Research Center (NCGM) Pharmacy Department and the Council for the Appropriate Use of Drugs, in collaboration with the Council for the Appropriate Use of Drugs, the project is promoting the appropriate use of medicines in the northern region of Vietnam, centered on Bac Mai Hospital, and continued active online activities during the pandemic. Medication support tools, some of which can be distributed to Vietnamese patients and learned with their families at home, have received high praise. In the future, we plan to implement a new project with the cooperation of the National Cancer Center.

Mr. Ryosho Imai, Vice Chairperson (Takeda) of the JPMA International Affairs Committee's Asia Subcommittee, introduced Takeda's activities on dengue fever and the Japan-Vietnam bilateral project on hereditary angioedema (HAE), a rare disease. The Vietnamese Ministry of Health showed great interest in the dengue fever vaccine and the efforts to prevent and control the disease through industry-academia-government collaboration, especially since dengue fever is a serious disease in Vietnam. The company has already applied to the Vietnamese authorities for registration of its dengue fever vaccine and HAE treatment, and requested that the review process proceed without delay for the sake of Vietnamese patients.

Closing remarks

So far, three joint symposiums have been held between PMDA and the Vietnamese Drug Administration. The JPMA has fully supported the holding of the symposium as a platform for the public and private sectors of the two countries to deepen mutual understanding of pharmaceutical affairs in both countries and for better development of pharmaceutical regulations. Discussions are underway for the next symposium to be held at the end of 2023. Mr. Dao Hong Lan, Minister of Health of Vietnam, said at the closing of the meeting, "The Vietnamese Ministry of Health always provides opportunities to exchange views like this one, and if there are any matters that require further discussion, we are always willing to exchange views. We hope that the JPMA will always be ready to discuss with the Vietnamese side. We hope that cooperation between the public and private sectors in Japan and Vietnam will be further strengthened and that the improvement of access to medicines in both countries will be accelerated in the future.

( Masayo Higashiyama, Leader, Vietnam Team, Asia Committee, International Affairs Committee)

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