Topics The 7th Japan-Thailand Joint Symposium" was held.
The 7th Japan-Thailand Joint Symposium" was held on January 13 and 14, 2021, hosted by the Thai Food and Drug Administration (Thai FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA). The symposium was originally scheduled to be held in April 2020, but due to the COVID-19 pandemic, the date was postponed to January 2021 and the symposium was held online. 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 aims 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 both 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 Japan's and Thailand's efforts for efficient review and post-marketing safety measures.
Considering that the symposium was held online, the program of the symposium was as follows: Part 1: General Session on January 13, Part 2: Pharmaceuticals Session, and Part 3: Medical Devices Session on the morning of January 14.
A total of 167 participants from Japan, including Dr. Junko Sato, Director of International Affairs, Pharmaceuticals and Medical Devices Agency (PMDA), PMDA, Ministry of Health, Labour and Welfare, pharmaceutical association member companies, and member companies of Japan Federation of Medical Devices Associations (JFMDA), and from Thailand, Dr. Paisarn Dunkum, Commissioner of the Thai FDA, Thai FDA and Thai industry. The symposium was attended by a total of 315 people from Thailand, including Dr. Paisarn Dunkum, Commissioner of the Thai FDA, and 148 people from the Thai industry.
First, Mr. Yasuhiro Fujiwara, President of PMDA (pre-recorded) and Dr. Paisarn Dunkum, Secretary-General of Thai FDA gave opening remarks.
Japan Pharmaceuticals and Medical Devices Agency
President Yasuhiro Fujiwara
Secretary-General, FDA, Thailand
Secretary-General, FDA, Thailand
In the first part of the general session, the current regulations on pharmaceuticals and medical devices and the latest situation of the pharmaceuticals and medical device industries in both countries were discussed, and in the second part of the pharmaceuticals session, the respective efforts of both countries regarding pharmaceutical regulations were shared. This paper focuses on the presentations from the Thai side.
Keynote Speech
Mr. Paisarn Dunkum, Secretary-General, FDA, Thailand
The Thai FDA is an important agency for the country's healthcare system and economy, and has been strengthening its functions under the 5S strategy in order to operate an organization that is recognized on a global level.
5S Strategy
- 1.Speed: Service efficiency, digital automation
- 2.Safety: improving health literacy and enforcing the law along with a comprehensive surveillance system
- 3.Satisfaction: increase consumer satisfaction and provide consumer-centered services
- 4.Supporter: Increase economic value and competitiveness
- 5.Sustainability: Stable supply of medicines and medical supplies
And in order to provide consistent services, we are focusing on three steps.
- Step 1 e-Submission
- E-Applications can be submitted electronically on the e-System
- Step 2 e-Review
- Examiners can review on the e-System
- Step 3 Digital Signature
- Electronic signatures and electronic licenses can be issued in the electronic system.
There are 186 processes for electronic application and approval, and we have successfully converted all of them to electronic.
In addition, the Thai FDA has attached great importance to international cooperation and has put a lot of effort into it. Cooperation with Japan's PMDA has been close and fruitful in the COVID-19 disaster. Both parties have been exchanging information through the Virtual Conference System. The efforts of the Thai FDA and all stakeholders over the past year have resulted in the global recognition of the Thai FDA's efforts.
Today, the world is more complex, but the world is more connected than ever before. In this context, the Thai FDA is well aware of the importance of international partnerships and the benefits and trade balance of improving consumer protection systems in the health care sector. They are also important drivers for the country's economic development. Therefore, sharing and exchanging information with each other, moving forward together in these increasingly serious situations, and working together to improve the system will lead to consumer protection and economic development in the health sectors of both countries, and lead to stable insurance systems. What we have learned from the crisis is that no matter how serious the situation is, the important first step to overcome the crisis is to work together. It is very difficult to achieve sustained results, but with the efforts and close relationship between our two countries to date, I am confident that we can achieve this goal.
Regulatory update
Pharmaceutical Regulation Updates
Mr. Surachoke Tangwiwat, Deputy Secretary-General, FDA, Thailand
Currently, we are promoting support for science and technology, expediting patient access, and strengthening post-marketing monitoring. In addition, we are managing the product lifecycle in collaboration with related organizations.
In relation to COVID-19, we are also promoting the development of vaccines in Thailand. Medicines already in use overseas are imported under an Emergency Use Authorization (EUA). At the same time, technology transfer from overseas companies is underway, and AstraZeneca is involved from the plant improvement stage.
AstraZeneca is working to harmonize regulations related to medical devices within the ASEAN region (AMDD), and a post-marketing alert system will go into effect in May 2021, with four new classes of medical devices (Class 1: Listing, Class 2 and 3: Notification, and Class 4: Class 5 and 6: Class 6). 2 and 3 are Notification, and Class 4 is License).
Good Registration Management
Standardization of submission and review process Good Registration Practice and its Practical Action at Thai FDA
Mr. Supatra Phongsri, Senior Professional Level, Medicines Regulation Division, FDA, Thailand
Drug Evaluation Pathways, Drug Evaluation Process, Submission Dossier, etc. will be explained.
The reference pharmacopoeias are International Pharmacopoeia (IP), United States Pharmacopoeia (USP), British Pharmacopoeia (BP), BP (Animal Drugs), European Pharmacopoeia (EP), Thai Pharmacopoeia, and Japanese Pharmacopoeia (JP), with JP added in 2019.
For a smooth review, the application documents must be of good quality, in a structure and format acceptable to the Thai FDA, and of sufficient quality (reliability, quality, completeness, traceability) for evaluation. As regulatory requirements are updated and reviewed, an understanding of the regulations and regulatory framework is necessary for both the applicant as well as the regulator.
As part of Thailand's Good Registration Management (GRM) approach to the approval review system, a pre-submission meeting can be held between the applicant and the review team prior to application. If the applicant is able to provide the information required by the Thai FDA, the applicant is encouraged to apply for this meeting.
The review is basically conducted in accordance with the Standard Operating Procedures (SOPs). In order to strengthen the capacity and function of regulatory examiners, we are also working on internal (senior examiners mentoring junior examiners) and external training (TGA, WHO, etc.) Reliance on SRA (abridged review), regional strengthening (harmonized ASEAN Joint assessment), etc. We are also working on collaboration.
Communication is important in the assessment process and needs to be improved and enhanced. Miscommunication can lead to significant losses, and if communication between the examiner and applicant is unclear, there is a risk of delayed and costly examinations. It is important to implement good communication, and it is necessary to strengthen the cooperation of the examining organizations and establish a clear communication process.
Scientific consultation
Scientific consultation for efficient communication with industry Scientific consultation at Thai FDA
Mr. Nalinratt Dhiraouransakun, Pharmacist, Practitioner Level, Medicines Regulation Division, Thai FDA
The Thai FDA's policy (Speed, Safety, Satisfaction, Supporter, Sustainability) was introduced at the beginning of the presentation, and it is important for the FDA to be aware of the potential for future breakthrough drugs (e.g., cell medicine and gene therapy, vaccines and new drugs, new biologics, biosimilars). He also mentioned the importance of effective use of the Scientific Advisory System prior to submission of a new drug application (e.g., cell medicine, gene therapy, vaccines and new drugs, new biologics, biosimilars).
The Scientific Advisory System provides advice and communication on matters related to development, submission, and non-clinical matters at any stage of development. The form must first be submitted, and the Thai FDA will respond either face to face, in writing, or by refusal. This system is also used for COVID-19 vaccines and therapeutics.
Benefit / Risk management through a product lifecycle
How to manage Benefit / Risk balance of pharmaceuticals from approval review to post-marketing including risk management plan and approval condition
Mr. Wittawat Viriyabancha, Pharmacist, Professional Level, Medicines Regulation Division, Thai FDA
To date, the Thai FDA has put in place the necessary regulations and infrastructure to achieve "benefit-risk management throughout the product lifecycle.
The FDA recognizes the importance of "science and technology development" in pharmaceuticals and the need for regulatory flexibility. It has introduced "regulatory science" to create an appropriate and efficient regulatory framework. Nevertheless, it is important to note that these moves do not imply compromises on product quality, safety, and efficacy. We will continue to work with other competent authorities to address issues.
Conclusion
The 7th Japan-Thailand Joint Symposium was held online for the first time, which was different from a face-to-face meeting in some ways, but it was a meaningful symposium where industry and government were able to actively exchange opinions from their respective standpoints. Based on this symposium, we hope that regulatory harmonization between the two countries will progress, and that the pharmaceutical and medical device industries will further develop through public-private partnerships and cooperation between the two countries, so that innovative pharmaceutical products can be delivered to the people of both countries as quickly as possible.
( Tomohiro Horio and Megumi Yoneyama, Thailand Team, Asia Division, International Committee)