Topics The 8th Japan-Thailand Joint Symposium" was held

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The 8th Japan-Thailand Joint Symposium" was held on January 25 and 26, 2022, hosted by the Thai Food and Drug Administration (Thai FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA), as in 2021, The symposium was held online in light of the spread of novel coronavirus infection (COVID-19). In accordance with the Memorandum of Understanding on Regulatory Cooperation for Pharmaceuticals and Medical Devices signed between the Thai FDA and the Ministry of Health, Labour and Welfare in April 2018, this symposium aimed to deepen mutual understanding between Japanese and Thai pharmaceutical officials and form the basis for cooperation for pharmaceutical and medical device regulation and development in the two countries. The symposium featured sessions on new drug review and medical device review, where the latest information on pharmaceutical and medical device regulations in both countries was shared and discussed, including regulatory updates in Japan and Thailand, regulatory support for COVID-19 vaccines and therapeutics, and actual GMP clearance for pharmaceutical products manufactured overseas. The discussion included the following

Considering that the symposium was held online, the program of the symposium consisted of Part 1: General Session on January 25, Part 2: Pharmaceuticals Session, and Part 3: Medical Devices Session on the morning of January 26. From Japan, Ms. Junko Sato, Director of International Affairs, Pharmaceuticals and Medical Devices Agency (PMDA), PMDA, Ministry of Health, Labour and Welfare, pharmaceutical association member companies, and Japan Federation of Medical Devices Associations (JFMDA) member companies, and from Thailand, Mr. Paisarn Dunkum, Secretary-General, FDA of Thailand, and other representatives from the Thai FDA. Mr. Paisarn Dunkum, Secretary-General of the Thai FDA, and a total of 339 participants from the Thai FDA and Thai industry attended the symposium. First, opening remarks were made by Mr. Paisarn Dunkum, Secretary-General of the Thai FDA, and Mr. Yasuhiro Fujiwara, President of PMDA.

In the first part of the general session, the current regulations on pharmaceuticals and medical devices in both countries and the latest regulatory status of the pharmaceutical and medical device industries were discussed. In the second part of the pharmaceutical session, the regulatory support for COVID-19 vaccines and therapeutics and the actual GMP clearance of pharmaceutical products manufactured overseas were shared. The second part of the session was dedicated to the pharmaceutical industry. This paper focuses on the presentations from the Thai side.

Regulatory Update
　

Mr. Surachoke Tangwiwat, Deputy Secretary-General, FDA, Thailand

In 2021, laws, ministerial ordinances, and government notifications related to pharmaceuticals, as well as notifications issued by the Thai FDA, and notifications from the Department of Pharmaceuticals were also issued. 2021 saw the issuance of notifications and orders related to vaccines as well as pharmaceuticals, and also emergency use permits, and the following three points were shared.

(1) Emergency use authorization and approval with conditions

Many of them require urgency and registration of applications in multiple countries, including Thailand, so uniform rules and certain conditions must also be in place. The Thai FDA uses a common template, the ASEAN Common Technical Dossier (ACTD) or ICH-CTD template. The Thai FDA conducts a simplified review by referring to the evaluation and review results of the World Health Organization (WHO) and developed countries such as the U.S., Europe, Australia, and Japan.

(2) Rules, procedures, conditions, etc. related to distribution

In order to manage distribution, we collect information from drug users on actual usage, response from 2020 when COVID-19 infection started to spread, and countermeasures.

The rules on modern drug distribution were signed on May 14, 2021 and entered into force on January 1, 2022. Companies (manufacturers and importers) must comply with the standards and renew their own licenses during 2022.

(3) GMP inspections of pharmaceuticals and medical devices overseas

This is based on Thailand's Pharmaceutical Law (French calendar 2510 edition). If there is a GMP certificate issued by an overseas authority, the application can be filed in accordance with the review rules by the Thai FDA. However, if there is no GMP certificate issued by an overseas authority, a GMP inspection must be conducted by the Thai FDA. Since it is difficult to conduct an actual inspection overseas, we review and approve GMP-related applications instead.

RA's support to COVID-19 related medicines and vaccines
　

Mr. Parichard Chirachanakul, Pharmacist, Senior Professional Level, Medicines Regulation Division, FDA, Thailand

In preparation for the spread of COVID-19, the Thai FDA has taken a flexible approach to approval, including issuing three notices regarding emergency use of the drug and conditional approval.

The Thai FDA has two main areas of oversight: pre-marketing and post-marketing. For pre-marketing, when obtaining an import license, manufacturing license, or marketing license, a Thai FDA number and registration number must be obtained for the drug in question. Only then can you import, manufacture and sell the product.

Because the coronavirus vaccine is a new vaccine and requires urgency, we have made it possible to submit a module-based application, which is different from the usual way of doing things. We were able to shorten the time from the start of evaluation to approval to 30 business days for the Corona vaccine that we approved. In addition, since the Corona vaccine requires cold chain distribution, the traditional method of labeling could have resulted in quality loss when the vaccine was imported into Thailand, so we adopted an e-labeling approach.

For conditional approval for emergency use, this must be based on a risk management plan. Surveillance for adverse events following immunization (Adverse Events Following Immunization, AEFI) and adverse reactions is also required.

Vaccine research and development is also underway in Thailand. ChulaCov19, an mRNA (messenger RNA) vaccine developed by Chulalongkorn University, is in phase II clinical trials. COVIGEN, a DNA vaccine developed by BioNet, is in Phase I clinical trials, and a plant-derived vaccine called Baiya is also in Phase I. In addition, HXP-GPOVac, a non-activated vaccine from the Pharmaceuticals Authority of Thailand, is in Phase II/III clinical trials.

We have made a concerted effort to combat this pandemic as quickly as possible. A total of six vaccines have been approved, as well as small molecule therapeutics such as Remdesivir, Favipiravir, and Olumiant. In addition, monoclonal antibodies Casirivimab, Imdevimab, and Sotrovimab have been approved.

Mr. Pornkanok Chankum, Pharmacist, Practitioner Level, Health Product Vigilance Center, Strategy and Planning Division, FDA, Thailand

The relevant departments of the Thai FDA have been consulting with us since the end of 2020 and we are ready for the first vaccination in February 2021. Adverse reactions and adverse events are monitored jointly by both the Health Product Vigilance Center (HPVC), which is under the jurisdiction of the Department of Disease Control of the Thai government, and the Department of Epidemiology of the Department of Disease Control (DDC). the HPVC network also receives information from pharmacies, hospitals, DDC, the Centers for Disease Control, university institutes, and research institutions. Such information is also used by the Thai FDA team to conduct risk assessments. In addition, the WHO is also provided with Thailand's information.

We also conduct active surveillance using Mor-Prompt, an app developed by the Thai Ministry of Health. Each citizen can check when they were vaccinated and what kind of adverse reactions they had, in other words, their vaccination history. When there is a severe adverse reaction, there is a hospital web-based means of communication, which is evaluated by health care professionals. First, once a report is received, a risk assessment is performed. For example, what type of adverse event, whether it is an adverse reaction, what type of vaccine was given, and such information is collected and reported to the committee for evaluation. If the information is incomplete or missing, further investigation will be conducted.

GMP clearance of overseas pharmaceutical manufacturers
　

Mr. Waranon Cheewajorn, Pharmacist, Practitioner Level, Medicines Regulation Division, FDA, Thailand

The Regulatory Framework consists of three phases: the first is the licensee import, manufacturing, and marketing authorization; the second is drug registration, which we manage according to the ASEAN Common Technical Drug Submission Format (ACTD); and the third is compliance verification, which we manage according to the ASEAN Common Technical Drug Submission Format (ACTD). The third is Compliance Verification, which must be done in parallel while the drug registration and compliance verification are still in place for the drug product.

Today I would like to talk specifically about GMP Clearance of Overseas Pharmaceutical Manufacturers, and there are four laws and regulations related to GMP clearance: the Pharmaceuticals Act, the Ministry of Health Ordinance, the Thai FDA Notification, and the PIC/S Guidelines.

The purpose of GMP clearance is to assess and evaluate that pharmaceutical manufacturing plants and factories located outside of Thailand meet the same standards as PIC/S and GMP, and to ensure that pharmaceutical products imported into Thailand also meet standards for quality, efficacy, and safety.

Evidence required for the assessment will include GMP certification, site master files, quality manuals, policies, and procedures. Currently, this covers non-sterile, sterile, and bio-formulated products as well as finished pharmaceutical products. The method of enforcement is voluntary, and an application for GMP clearance must be filed before any product can be manufactured or sold in Thailand. Even if the product is made using the same method, if the site has changed, GMP clearance is required. In addition, renewal is required when the GMP clearance expires.

The ASEAN Listed inspection service, which is responsible for smooth regulatory science in the ASEAN region, is comprised of the Health Sciences Authority of Singapore (HSA), the National Pharmaceuticals Regulatory Authority of Malaysia (NPRA), the National Agency for Drug and Food Control (NADFC) of Indonesia, the Thai FDA, and the Philippine The results of the ASEAN Listed inspection service must be referenced when exporting medicinal products manufactured in an ASEAN Listed inspection service member country to any of the 10 ASEAN member countries. However, only finished products are covered. Also, biologics and blood products are not included.

Conclusion

The 8th Japan-Thailand Joint Symposium was held online as in 2021 due to the COVID-19, but the speakers gave detailed explanations of their countries' sincere efforts toward COVID-19, and a frank exchange of opinions on practical aspects took place during the Q&A session. The symposium was very meaningful, with a frank exchange of opinions on practical matters. The symposium was very fruitful, with a frank exchange of opinions on practical matters during the Q&A session. We hope to make the most of such exchanges to deliver innovative medicines and vaccines more promptly to the people of both countries.

( Masako Okamoto and Megumi Yoneyama, Thailand Team, Asia Subcommittee, International Committee)

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