May 2024
David Hung and Teresa Huang
The “Regulations for Reporting Serious Adverse Drug Reactions” have been in effect for nearly 20 years since their issuance on August 31, 93 (2004) of the Republic of China. In order to align with practical operations and comprehensive reporting requirements, the Taiwan Ministry of Health and Welfare announced amendments to these regulations on March 28, 113 (2024), changing the title to the “Regulations for Reporting Severe Adverse Reactions of Medicaments” (hereinafter referred to as “these Regulations”). The amendments took effect on January 1, 114 (2025).
Key amendments include the addition of a reporting online platform, specifications for information to be included in the reporting form, standardization of notification dates, procedures for notifying drug manufacturers, obligations for proactive investigation, obligations for data retention periods, and compliance with personal data protection laws. These changes significantly increase the legal responsibilities of medical institutions, pharmacies, and drug manufacturers. Relevant institutions and companies should pay close attention. The following are summarized highlights:
I. Amendment of Reporting Procedures
1. Reporting via Online System
To promptly gather drug safety-related information, a designated online system specified by the central health authority is established as the reporting platform. If necessary, medical institutions, pharmacies, or drug manufacturers may initially report orally, by fax, or by email, but must still complete online reporting within the specified timeframe. If the competent authority deems the reported content insufficient or unclear, the notifier will be required to make corrections within a specified period (Article 3 of these Regulations).
2. Content and Format of Reporting Form
The amendments specify detailed requirements for information to be included in the report, including (1) name of the notifier, contact information, and the name and address of their service unit, (2) dates of occurrence and notification of serious adverse drug reactions, (3) information source of the notified serious adverse drug reactions, (4) patient identification code, gender, age, or date of birth, (5) patient medication information, and (6) category, symptoms, and relevant descriptions of serious adverse drug reactions (Article 5 of these Regulations). Additionally, to enhance the practicality and convenience of online reporting systems and facilitate international alignment, reporting forms may adopt the standardized electronic transmission format of the International Council for Harmonisation (ICH) (Article 4 of these Regulations).
II. Classification of Reporting Deadline Types
After the amendment, these Regulations differentiate the reporting deadlines for different severity levels of adverse drug reactions and different reporting entities. Medical institutions and pharmacies should report adverse drug reactions resulting in death or life-threatening conditions within 7 days from the date of becoming aware and other adverse reactions within 30 days from the date of becoming aware (Article 6, Paragraph 1 of these Regulations). If the reporting entity is a drug manufacturer, regardless of the type of adverse drug reaction, it should complete the notification within 15 days from the date of becoming aware (Article 7 of these Regulations).
III. Procedure for Drug Manufacturers Receiving Notifications
To facilitate drug manufacturers in conducting case investigations and evaluations and continuously tracking reporting situations, these Regulations introduce a new provision allowing the competent authority to notify drug manufacturers upon receiving serious adverse drug reactions reports from medical institutions or pharmacies regarding serious adverse drug reactions. Upon receiving notification from the competent authority, drug manufacturers should also comply with the aforementioned reporting procedures for adding, updating, or supplementing notification data (Article 8 of these Regulations).
IV. Obligation for Drug Manufacturers to Conduct Proactive Investigations
Taking into account requirements from international health authorities regarding the completeness and authenticity of reported data, these Regulations introduce new provisions requiring drug manufacturers to proactively investigate reported serious adverse drug reactions. When drug manufacturers become aware of serious adverse drug reactions, they should proactively investigate and assess the causality of the reported data. If, based on the investigation and assessment results, drug manufacturers find serious adverse drug reactions that are unexpected or occur at a frequency exceeding expectations, or if there is a need to add or modify contraindications or usage restrictions, they should follow the provisions of Article 6 of the Regulations for the Management of Drug Safety Surveillance (Article 9 of these Regulations).
V. Obligation for Data Retention Periods and Compliance with Personal Data Protection Laws
Considering that documents and data related to serious adverse reactions are among the original data of safety surveillance and taking into account the regulations set by international health authorities regarding the retention of data related to serious adverse reactions, these Regulations introduce new provisions requiring medical institutions and pharmacies to retain documents and data related to serious adverse reactions for at least five years. Drug manufacturers should retain such data for five years after the expiration of the manufacturing or import permit for the drug (Article 10, Paragraph 1 of these Regulations). Additionally, these Regulations also introduce new provisions requiring medical institutions, pharmacies, and drug manufacturers to comply with the Personal Data Protection Act when collecting, processing, or utilizing personal data according to these Regulation (Article 11 of these Regulations).
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