Topics The 4th Japan-Vietnam Joint Symposium" was held

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The "4th Japan-Vietnam Joint Symposium" was held on December 5, 2023, hosted by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Vietnam Drug Administration (DAV). The Pharmaceutical Manufacturers Association of Japan (PMAJ) and the Japan-Vietnam Pharmaceutical Alliance for Veterinary Medicine (JPAV) cooperated in the operation of the symposium as supporting organizations. The symposium aims to deepen mutual understanding of pharmaceutical affairs between the two countries and to better develop pharmaceutical regulations. The symposium featured presentations from both authorities on three topics: regulatory updates on marketing authorization of medicines, timely access to innovative medicines, and promotion of the proper use of medicines.

Introduction

The symposium was held at the Pullman Hotel in Hanoi, Vietnam, in a hybrid format with online auditing. About 90 participants, including those who traveled from Japan, gathered at the venue, and the total number of participants including online participants was 380. The number of participants from Vietnam, including 12 from the authorities and 240 from industry, exceeded the number of participants from Japan, indicating the high level of interest in this symposium.

The symposium began with opening remarks from PMDA Director Hiroyoshi Arai, followed by opening remarks and a keynote speech by DAV Deputy Director General Le Viet Dung. Mr. Arai thanked the organizers and expressed his hope that PMDA's experience and knowledge sharing will contribute to the reform of the Vietnamese system and improve access to medicines for patients, and that this symposium will lead to a better understanding of pharmaceutical regulations and development of both countries, Asia, and the world. Mr. Le Viet Dung thanked the organizers and noted that 2023 is the 50th anniversary of the establishment of diplomatic relations between Vietnam and Japan, and expressed his hope that the Vietnamese pharmaceutical industry will grow further within the framework of the Economic Partnership Agreement with Japan and that both countries will be able to implement cooperative projects through new information sharing at this symposium. He also expressed his hope that the Vietnamese pharmaceutical industry will further grow within the framework of the Japan-Japan Economic Partnership Agreement.

Next, Mr. Daisuke Tanaka, Director of PMDA's International Division, gave a keynote speech in which he shared the progress and experiences of PMDA since its inception. Expansion of personnel and shortening of review period, implementation of capacity building to Asian countries through the Asian Pharmaceuticals and Medical Devices Training Center (PMDA-ATC), collaboration through the Asian Cancer Clinical Trial Network Project led by the National Cancer Center, and collaboration between the National Cancer Center and the PMDA after 2017. He introduced the cooperation between Vietnamese and Japanese pharmaceutical regulatory authorities, the use of Reliance in drug approval review, and finally, the cooperation from PMDA to Vietnam. During the explanation of Reliance, many flashes were seen from the audience to capture the content of the explanation on camera, indicating the high level of interest in Reliance.

1. regulatory updates on marketing authorization of pharmaceutical products

On the Japanese side, Mr. Kenji Kuroiwa of MHLW's Office of International Pharmaceutical Regulations explained the activities of MHLW and PMDA in Asia, including Asian Network Meetings, symposia, bilateral meetings, PMDA-ATC activities, the special approval system and emergency approval system for coronary disaster initiatives, and the emergency approval system for post-coronary initiatives. The committee also reported that a review of the application of the emergency approval system for the future will be considered as a post-Corona initiative.

The Vietnamese side was represented by Mr. Nguyen Tuan Anh, Deputy Director of DAV's Drug Registration Division, who gave an update on Vietnam's major pharmaceutical regulations and drug registration system, international cooperation and harmonization activities, and the future direction of DAV's activities. The newly promulgated Notification on Registration of Pharmaceuticals and Pharmaceutical Ingredients, Notification on Pharmaceuticals Requiring Bioequivalence (BE) Studies, and Notification on Technology Transfer and Registration of Contract Manufactured Pharmaceuticals, which will be promulgated after 2022, include the introduction of electronic submission, the requirement for registration of imported products with a Certificate of Pharmaceutical Product (CPP) and its associated registration requirements, and the registration of pharmaceutical products with a Certificate of Pharmaceutical Manufacture (CMP). The changes include the introduction of electronic application, the relaxation of the requirements for the Certificate of Pharmaceutical Product (CPP) and equivalent legal documents at the time of import registration, the use of identification codes in the future, and the doubling of the number of pharmaceutical ingredients requiring BE testing. International cooperation activities include Vietnam's participation in the Joint Assessment Commitment Group (JACG) program of the Association of Southeast Asian Nations (ASEAN) Pharmaceutical Product Working Group (PPWG), and participation in Reliance and Recognition workshop. In terms of international cooperation, he mentioned the shortage of personnel involved in registration audits and emphasized the need for a Reliance Pass. Regarding the future, he shared that the Pharmaceutical Affairs Law is scheduled to be revised by the end of 2024, that an online application system and digitization of application materials are planned, and that digitization of drug information using one-dimensional barcodes and two-dimensional codes is planned.

2. timely access to innovative medicines

From the Japanese side, Mr. Keita Kawaji of PMDA's New Drug Review Department IV gave a presentation on the review system for new drugs and post-approval lifecycle management in Japan. He also explained that the time from application to approval is within 12 months for regular items and within 9 months for priority review items, and that some review reports are translated into English and published. Some review reports are translated into English and published. As for post-approval management, he explained that there are partial change applications, minor change notifications, reexamination and reevaluation systems, and periodic GMP compliance inspections of manufacturing sites.

From the Vietnamese side, Mr. Hoang Thanh Mai, Deputy Director of DAV's Pharmaceutical Business Management Division, spoke about the regulations regarding import approval of orphan drugs and drugs for special therapeutic needs in Vietnam. The criteria for import licenses for orphan drugs and medicines for special therapeutic needs and the application for licenses are stipulated in the 2017 Decree, which requires that orphan drugs must be on the published list of orphan drugs and must be allowed to be distributed in other countries. Among medicines that meet special therapeutic needs (e.g., emergency medicines, anti-addiction, anti-rejection drugs, HIV, cancer, tuberculosis, malaria drugs, vaccines, etc.), vaccines, for example, require the commitment of foreign manufacturers and suppliers to guarantee their quality, safety, and efficacy. The requirements were explained.

3. promotion of proper use of medicines

On the Japanese side, Maki Yoro of the PMDA's Safety Information and Planning Administration Department introduced Japan's drug safety monitoring system and the PMDA's information provision services as part of its efforts to ensure the proper use of drugs. She emphasized the importance of cooperation among the parties concerned, such as the government, manufacturers and distributors, medical professionals, and patients, in considering the proper use of drugs based on post-marketing adverse drug reaction information. The PMDA also explained that safety information is provided promptly through its website and e-mail distribution service, and the history of the digitization of the accompanying documents in Japan.

Mr. Tran Thi Phuong Thanh, Deputy Director of DAV's Pharmaceutical Quality Control Department, gave a presentation on the handling of substandard and counterfeit pharmaceutical products in Vietnam.

He explained that quality control activities include inspections of manufacturing sites by the Ministry of Health and local authorities, and market sampling by the Pharmaceutical Quality Control Center. The number of unapproved, out-of-specification drugs, mislabeled drugs, and drugs that have been subject to recall overseas have been subject to recall from the market, and the number of recalls has decreased over the past five years. As for counterfeit medicines, the fact that the detection rate of counterfeit medicines has been less than 0.1% for the past 10 years is considered favorable, but the reasons that make it difficult to combat counterfeit medicines include: Vietnam has a long border and there is a lot of smuggling; counterfeit medicines are small, easy to bring in, and have high profit margins, among others; information on manufacturing and sources of supply is of little interest to retailers and consumers; and there is a lack of information about the source of supply online. In addition, retailers and consumers are not interested in information on the manufacture and source of counterfeit medicines, and online purchases are increasing. As future countermeasures, the panelists proposed the development of laws, product control through networks from manufacturing to sales, strengthening inspections, and cooperation with neighboring countries, as well as referring to the control systems of the U.S., EU, Australia, and Japan.

Closing Remarks

The participants from DAV and the Vietnamese industry association asked the Japanese authorities how they would handle cases where there are too many applications to respond in time, how they would handle cases where several Asian and ASEAN countries have already adopted the PMDA's review report system, and how they would deal with cases where there are too many applications and the Japanese authorities cannot respond in time. The participants from DAV and industry associations in Vietnam asked specific questions to the Japanese authorities, such as how to deal with the large number of applications received and how to respond to them in time, how information is shared in the review process using the PMDA's review reports that have already been adopted by several Asian and ASEAN countries, and how to respond after receiving information on adverse drug reactions. On the other hand, there were also some themes that were discussed by the two authorities that differed greatly from each other, indicating the difficulty in selecting topics for discussion between the two countries.

In their closing remarks, Mr. Arai and DAV Deputy Director General Le Viet Dung expressed their pleasure and gratitude for having held the first face-to-face meeting in Hanoi in many years, and their expectations for further strengthening cooperation and collaboration between the two countries.

The management of the symposium, which was the first face-to-face meeting in four years, was not easy, as there were few people with experience in holding face-to-face meetings due to the turnover of the people involved and a new requirement to apply to the Vietnamese Ministry of Foreign Affairs for permission to hold an international conference from the perspective of Vietnam's national security. However, we were able to gather and discuss directly with the people concerned at the venue, and also spent precious time exchanging words to understand each other during breaks and lunches. While the Corona Disaster has enabled us to make good use of the online environment, and this symposium was able to attract a large number of participants online, we were also reminded of the importance and value of communication, which cannot be achieved online. I strongly feel that both virtual and real platforms are necessary to develop the relationship between the public and private sectors in both countries for early access to medicines in the future.

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

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