Affiliations 

  • 1 Pfizer R&D Japan, Tokyo, Japan. rie.matsui@pfizer.com
  • 2 Takeda Pharmaceutical Company Limited, Osaka, Japan
  • 3 Astellas Pharma Inc., Tokyo, Japan
  • 4 Ferring Pharmaceuticals Ltd., Kowloon, Hong Kong
  • 5 Abbott Indonesia, South Jakarta, Indonesia
  • 6 Merck Sharp & Dohme, Taipei, Taiwan
  • 7 KPBMA, Seoul, Korea
  • 8 GE Healthcare AS Korea, Seoul, Korea
  • 9 Pharmaceutical Association of Malaysia (PhAMA), Selangor, Malaysia
  • 10 Pfizer, Inc. (Philippines), Makati, Philippines
  • 11 Pfizer (Thailand) Limited, Bangkok, Thailand
  • 12 Takeda Pharmaceuticals International AG, Singapore, Singapore
  • 13 Pharma Group Vietnam, Ho Chi Minh, Vietnam
  • 14 Sanofi GRSP China Team, Beijing, China
  • 15 Pfizer Limited (India), Mumbai, India
Ther Innov Regul Sci, 2023 Mar;57(2):251-260.
PMID: 36215028 DOI: 10.1007/s43441-022-00462-5

Abstract

Under the COVID-19 pandemic, various electronic labeling initiatives have accelerated worldwide in the healthcare and pharmaceutical fields as part of a wider digital transformation [1, 2]. Although there is no universal definition of electronic labeling (e-labeling) globally, it is widely understood that e-labeling refers to the product information that is distributed via electronic means. There are 5 factors to be considered in e-labeling, and these are discussed in this publication. APAC is an industry-driven initiative with 13 R&D-based pharmaceutical associations joining from 11 markets in Asia. e-labeling was discussed as a new topic starting in 2020, and a 22-question survey was conducted in November 2021 to understand the current e-labeling status. The survey results showed that e-labeling initiatives were at different levels of maturity in the Asian region, although most markets have started to discuss e-labeling initiatives. Various challenges exist around e-labeling initiatives due to a variety of different approaches being taken in the region. It would be advisable to develop regional guidance on how to proceed with e-labeling initiatives in the Asian region to have a consistent and efficient approach. The close collaboration between agencies, Health Care Professionals (HCPs), patients, and industry associations is important to move e-labeling initiatives forward in Asia.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.