Topics The 1st Japan-Vietnam Joint Symposium" was held.

After introducing her personal history, she talked about the organization and role of PMDA.

He is taking the initiative in addressing the four "F's" (Patient First, Access First, Safety First, and Asia First) that he set forth when he became President of PMDA. PMDA's three major roles are the Safety Triangle (Review, Safety, and Relief), and its international expansion includes the formulation of the Grand Design for Regulatory Harmonization of Asia's Pharmaceuticals and Medical Devices, and the development of a new framework for the approval of pharmaceuticals and medical devices in the Association of Southeast Asian Nations (ASEAN) countries. PMDA is actively involved in the formulation of the Grand Design for Regulatory Harmonization of Pharmaceuticals and Medical Devices in Asia, and support for the enhancement of drug and medical device approval systems in the Association of Southeast Asian Nations (ASEAN) countries. The PMDA Asian Training Center (PMDA-ATC) holds training seminars in Japan and abroad. PMDA has held bilateral symposiums with many countries and hopes to cooperate with them in the future to improve access to medicines and establish Universal Health Coverage (UHC) in Vietnam.

Three key points were explained: Japan's review system, consultation system, and system for early commercialization.

In addition to the regular review system, Japan's review system includes a priority review system, a rare disease review system, a pioneer review designation system, and a conditional early approval system, each of which provides target review periods as well as criteria and conditions to be applied. The PMDA has been working to shorten the review period, and is striving to achieve this goal by setting targets for the review process and disclosing them to the public to ensure transparency and predictability. consultation, etc., at each stage of development from the early development stage to post-approval, and the fees for these consultations are also set. The consultation system contributes significantly to reducing development costs and shortening the review period by optimizing clinical trial design, etc., and is beneficial to both the regulatory authorities and companies. In addition, Vietnam aims to improve access to medicines for patients by establishing a new system called the Pioneer Review Designation System to promote early commercialization of innovative medicines and the Conditional Accelerated Approval System, which can be applied when there is a lack of treatment options for a serious disease but clinical trials are difficult or time consuming because of the small number of patients.

An overview of drug registration in Vietnam was given.

As of 2018, there were 20,857 registered drugs (including 6,203 imported drugs). The validity period of drug registrations is up to five years, with a maximum of three years for new drugs, vaccines and biologics, and those requiring safety and efficacy monitoring. Material forms can be submitted in the ASEAN-CTD (Common Technical Document) or the International Conference on Harmonization of Pharmaceutical Regulations (ICH)-CTD. The following are eligible for priority review: orphan drug listings, medicinal products that meet the treatment needs of emergency and disaster situations, and medicinal products manufactured in Vietnam that meet the requirements of the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the EU Good Manufacturing Practice (GMP) within the last 18 months. The priority review may be applied for when a drug is manufactured in Vietnam on a production line that meets the requirements of the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperative Scheme (PIC/S) or EU Good Manufacturing Practice (GMP) within the last 18 months. Applications for registration will be reviewed by technical reviewers (affiliated with universities, research facilities, etc.) divided into five groups: legal documents, pharmacological documents (package inserts and labels), quality documents, clinical data, and bioavailability/bioequivalence (BA/BE) studies. Drug labeling will be reviewed in accordance with the requirements of the Ministry of Health Circular No. 1 of 2018, while technical requirements for application materials will be reviewed in accordance with ASEAN technical guidelines.

Finally, the Vietnamese authorities expect cooperation with Japan.

The actual review process at PMDA was explained in three points: the overall process of development and review of new drugs, the items required for approval and the scope of approval, and the evaluation of risks and benefits of new drugs in the review process.

He began by introducing the organization of PMDA's Review Department, the composition of the review team, and the review process from the time an application is received by PMDA until it is approved by the Minister of Health, Labour and Welfare, including the timing and roles of the Initial Interview and Review Report1 and Expert Consultation and Review Report2. The NHI price listing process after approval was also introduced, and the roles of Japan's two regulatory authorities, PMDA and MHLW, were discussed again. The PMDA is responsible for scientific review and consultation with external experts, while the MHLW is responsible for administrative decisions, management of the Drug Subcommittee, and NHI drug price listing. Next, the items required for approval and their scope were explained. The Law Concerning Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Products (Pharmaceutical Affairs Agency Law) stipulates the grounds for refusal of approval as "not to grant approval," while the Japanese application for approval is issued as an approval document when approval is granted, and if changes are required to the information in the approval application after approval, a change If changes are necessary after approval, a change application or a change notification must be submitted for changes that have little impact on quality or efficacy. In Japan, the content of the attached CTD is not considered an approved item. In Japan, the content of the CTD attached to a drug is not considered an approved item, and the content of the package insert is limited to the marketing name, indication, and dosage and administration. Lastly, I explained the risk-benefit evaluation in the new drug review process. A drug with no risk at all will not be approved, and risks can be reduced through management. At the review stage, the Office checks whether risk management is appropriate, and if the benefits outweigh the risks, the drug is considered for approval.

Among the applications for registration in Vietnam, the following explanation was given on the approval review procedure and quality requirements.

Registration of pharmaceutical products is regulated by the Ministry of Health Circular No. 32 of 2018 under the Law on Pharmaceutical Affairs, which is effective as of September 1, 2019. The approval review procedure is as follows: (1) the applicant submits the application documents to the DAV; (2) the application documents are given to the review specialist (or specialized agency) designated by the DAV; (3) the review specialist reviews the application, compiles it into a review report, and sends it to the DAV; (4) the DAV reviews the review report and if it meets the requirements (5) The Advisory Council evaluates whether or not to issue a registration number (approval) and submits an opinion to make a final decision. In addition to the Registration Regulations Circular, the requirements for registration are also set forth in the Circular on Labeling and Quality. Technical documents include guidelines issued by the DAV, as well as ACTD and ACTR (ASEAN Common Technical Requirements) of ASEAN, ICH, World Health Organization (WHO), US Food and Drug Administration (US FDA), European Medicines Agency (EMA) and other countries/other organizations' Guidelines and pharmacopoeias of other countries and organizations such as ICH, World Health Organization (WHO), US Food and Drug Administration (US FDA), and European Medicines Agency (EMA) can be referenced. As quality standards, Vietnamese Pharmacopoeia, British Pharmacopoeia (BP), United States Pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and International Pharmacopoeia (IP) issued by WHO can be referenced, and if the API is EP-certified (CEP), the ACTD S1-S7 parts are exempt from submission. If the specifications and test methods set by the company are registered (in-house standards), they must be stricter than the pharmacopoeia standards, and an analytical validation report based on ICH, pharmacopoeia, or other technical documents must be submitted.

The Japanese Pharmacovigilance (PV) system and post-marketing safety measures at PMDA were introduced.

Marketing Authorities Authorities (MAHs) are required to collect information on adverse drug reactions after the start of marketing, and post-marketing surveillance is mandatory for new drugs in Japan until reexamination. In addition, many new drugs are subject to an additional 6-month post-marketing surveillance (EPPV), which is unique to Japan and has led to an increase in the number of adverse drug reaction reports and, in some cases, early detection of adverse drug reactions, thus strengthening the information collection system. In Japan, there are three reporting routes to PMDA (1) from MAHs, (2) from healthcare professionals, and (3) from patients, and the collected side effect reports are entered into PMDA's database and shared with the MHLW. (3) Unlike (1) and (2), patients are not required by law to report adverse reactions, but rather do so on a voluntary basis. Adverse drug reaction reports from patients were started on a trial basis in Japan in 2012, and official acceptance has just started in March 2019, with the aim of increasing the number of reports by conducting activities to inform patients.

Next, the composition and duties of the PMDA's Drug Safety Division were explained in detail, as well as the process and time involved in obtaining adverse drug reaction information and revising the package inserts. In addition, we believe that MAH information collection activities for medical institutions are very important for post-marketing safety measures, and risk information on drugs under evaluation by PMDA and MHLW is posted on the PMDA website, and information on revisions to package inserts is also posted on the website along with a summary of the investigation and the reason for the revisions. The information on revisions to package inserts is also posted on the website along with a summary of the investigation and the reason for the revision. In addition, PMDA provides a service called PMDA medi-navi, which sends out information by e-mail on information that requires urgent and prompt action, such as yellow letters and blue letters issued by MAH based on MHLW's instructions. This service is available only in Japanese, but important safety information and safety measures are also available on PMDA's English web page.

The history, efforts, and future of PV in Vietnam were described.

In Vietnam, ADR (Adverse Drug Reaction Monitoring) information was collected for the first time in 1994 with the support of Sweden. The DI&ADR Center has been working on detection, evaluation, risk minimization, and risk communication of ADRs as PV activities. Since the establishment of the DI&ADR Center, the number of ADR reports has increased about 8 times. As for risk communication, the DI&ADR Center distributes information via Facebook, in addition to paper publication and website, and has 12,000 followers. We also provide free consulting services to healthcare professionals and respond to about 100 cases each year. We also provide PV training, primarily to central and provincial level hospitals. While our efforts to date have yielded positive results, there are still problems, including a lack of awareness among healthcare professionals, the pharmaceutical industry, and private healthcare facilities regarding the importance of PV, a lack of quality and quantity of human resources, and a disparity between central and local levels. In order to solve these problems, it is necessary to promote PV activities at all levels by integrating regulations, technical guidelines, protocols, and Standard Operating Procedures (SOPs) in collaboration with the Ministry of Health and related facilities. The following is a brief overview of the registration process in Vietnam.