Topics The 1st APAC e-labeling Regulators' Workshop held

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The APAC*1 e-labeling Expert Working Group (EWG) held the "1st APAC e-labeling Regulators Workshop" in online format on November 29, 2022. The main participating organizations are the National Pharmaceutical and Food Regulatory Agency of Indonesia (BPOM), the Central Drug Standards Control Organization (CDSCO) of India, the Drug Administration of the Ministry of Health of Vietnam (DAV), the Health Sciences Authority of Singapore (HSA), the Ministry of Food and Drug Safety of Korea (MFDS), the National Pharmaceuticals Regulatory Agency of Malaysia (NPRA), Food and Drug Administration (FDA) of the Philippines, Pharmaceuticals and Medical Devices Agency (PMDA), Food and Drug Administration (FDA) of Taiwan's Ministry of Health and Welfare, and the Food and Drug Commission Secretariat (FDA) of the Thai Ministry of Health.

Introduction

Purpose of the Workshop

The "1st APAC e-labeling Regulators Workshop" was held with the following two objectives

Background of the Workshop

To introduce the activities of the APAC e-labeling EWG and the background leading to the workshop, and to discuss how e-labeling in Asian countries is one of the important measures for DX in the healthcare sector, as the trend toward digital transformation (DX) is further strengthened by the Corona Disaster that started in 2020. APAC member countries are at various stages of e-labeling initiatives, and in the wake of the recent Corona disaster, Asian countries are rethinking the traditional paper-based provision of drug information. In addition to innovative methods to enhance and accelerate digitization and promptly provide the latest package insert information, we are also discussing how information should be provided from the user's perspective, taking into account the situation in Asian countries, and discussing interoperability to utilize e-labeling as part of digital health in the future. The committee is discussing the use of e-labeling as a part of future digital health.

At the 10th APAC in April 2021, we will share commonalities, advantages, and challenges in the Asian region, to put e-labeling into practice, to present a wider range of options, to make better choices in the future, and to have a somewhat unified approach in the Asian region. To develop and disseminate a position paper and, as part of efforts to achieve these goals, conduct a survey of APAC member associations' country regulations and needs, develop a blueprint (roadmap), and collaborate on e-labeling projects among regulatory authorities and pharmaceutical industry associations for the benefit of healthcare professionals and patients in the Asian region. It was agreed that it is important to cooperate in the e-labeling project among regulatory authorities and pharmaceutical industry associations for the benefit of healthcare professionals and patients in the Asian region.

Following this trend, the APAC e-labeling EWG was formed in July 2021, including members from APAC member countries, and as of January 2023, 38 members from 13 pharmaceutical associations in the Asian region are active. We reported the results of a survey*2 to understand the current status of e-labeling in the Asian region. Although the current status of e-labeling in Asian countries is still in the developmental stage, it was shared that all pharmaceutical industry associations participating in the APAC e-labeling EWG have started discussions on e-labeling. The roadmap for the APAC e-labeling EWG was presented, and it was proposed and agreed that the EWG will prepare a position paper in FY2022 to move forward in a unified manner to solve issues that transcend industry and regulatory boundaries, and that a workshop will be held to share information among regulatory authorities. The workshop will be held to share information among the regulators.

Contents of the 1st Workshop

Opening remarks and basic elements of e-labeling

The workshop began with opening remarks by Ms. Usanee Harnpramukkul of the Pharmaceutical Manufacturers Association of Thailand (PReMA).

Next, Ms. Rie Matsui, leader of the APAC e-labeling EWG of the Pharmaceutical Manufacturers Association of Japan (PReMA), explained that although there is no common definition of e-labeling worldwide, e-labeling is defined as (1) establishing a reliable e-labeling platform (for example, a regulatory authority website) to provide up-to-date package insert information electronically (2) GS1 barcodes, etc., should be attached to outer packaging and linked to e-labeling to facilitate access to and readability of the latest package inserts through smartphone apps, etc.; (3) paper-based package inserts should be eliminated and electronic access to package inserts should be the norm; and (4) The attached document will be created electronically and structured using XML, etc., so that it can be handled as data, and (5) Interoperability standards will be incorporated, and eventually it will be linked and integrated with other systems such as electronic medical records and electronic prescriptions, and utilized as a part of digital health. The elements of e-labeling in Japan are as follows.

Current status of e-labeling in Asian countries

As for the current status of e-labeling in Japan, he stated that Japan is ahead of the rest of the world at this point in time, as it has already implemented all but the interoperability standards. In Asia, Singapore has issued guidelines for e-labeling, and Taiwan has started pilot studies of e-labeling. The workshop featured speakers from the PMDA, Taiwan FDA, and Singapore Association of Pharmaceutical Industries (SAPI). On the other hand, in Europe and the U.S., the international standard (HL7FHIR) has been decided or is being actively considered for introduction to e-labeling, so we asked Pfizer UK to speak and share background on e-labeling in Europe and the U.S.

Ms. Sachiko Sugiyama from PMDA's Safety Information and Planning Administration Department talked about Japan's e-labeling initiative in detail under the title of "Current status and future of e-labeling", covering a wide range of topics from the revision of the Pharmaceutical Affairs Law to GS1 codes and attached document viewing applications The presentation by Mr. Sugiyama was followed by a very interesting and informative presentation. After Mr. Sugiyama's presentation, there was a very lively Q&A session, which clearly demonstrated the high level of interest in Japan's e-labeling initiative by foreign regulatory authorities.

Mr. PoWen Yang of the Taiwanese FDA spoke about the unification of labeling items and templates to facilitate the e-labeling initiative, the creation of a new platform to enable the creation of structured labeling in 2021, and the May 2022 launch of the e labeling's user-friendly interface was implemented, and that a pilot to eliminate bundling and provide labeling electronically was initiated in 2022.

Benjamin Tan of SAPI explained that the e-labeling trial in Singapore began in August 2019, with companies that wanted to participate in the e-labeling trial voluntarily, and feedback from healthcare professionals was reported by SAPI to the HSA. As a result, final guidance on e-labeling was issued in April 2021. In the case of e-labeling in Singapore, the labeling on the package insert must be changed if the package insert is discontinued, and if the package insert is changed only for shipments to Singapore, the packaging cost will increase, etc. These issues were shared.

Mr. Shimon Yoshida from Pfizer UK shared about e-labeling initiatives in Europe and the U.S., and their efforts for structured e-labeling using international standards (HL7FHIR).

Q&A, discussion and closing remarks

As the last session, a question-and-answer session and discussion among regulatory authorities only was held, chaired by Ms. Tomoko Osawa, Director of Safety Information and Planning Management Department of PMDA. Ms. Osawa commented, "We spent valuable time sharing information about the various stages each of us is at regarding e-labeling, the challenges each of us faces (including infrastructure development, standardization, etc.), our experiences to date, and an overview of our future plans. Although each country or region's situation may differ in terms of the type of e-labeling they are aiming for, it is important to continue to share information and cooperate with each other in the future. Let us continue the dialogue in order to realize a better situation for patients around the world. I sincerely thank you all for your participation and for this opportunity," he concluded. The workshop concluded with closing remarks by SAPI's Kum Cheun Wong.

Closing Remarks

After the workshop, we conducted a survey of the participants and received feedback from all respondents that their overall satisfaction with the workshop "exceeded expectations" or "very satisfied," which we will discuss further at the e-labeling session of the "12th APAC" to be held in April 2023. We are also planning to hold the "2nd APAC e-labeling Regulators' Workshop" while further discussing the e-labeling session at the "12th APAC" to be held in April 2023.

(APAC e-labeling EWG Leader: Rie Matsui, Sub-leader: Shinpei Niwa )

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