TaiMei MedTech's eSafety Pharmacovigilance System Becomes First Domestic Platform to Pass FDA FAERS E2B(R3) Submission Test; Company Files HKEX IPO Prospectus

Recently, Taimei Medical Technology’s eSafety pharmacovigilance system passed the E2B submission testing for the FDA FAERS system and obtained access to the production environment. This means that users of the eSafety pharmacovigilance system can easily submit post-marketing individual case safety reports to the FDA in electronic E2B format, thereby meeting FDA regulatory requirements.

In 2015, the FDA issued a Final Rule requiring that post-marketing safety reports be submitted electronically. Among the available methods, the E2B format, which adheres to the internationally recognized ICH E2B standard (Individual Case Safety Report transmission standard), has become the primary method for submitting individual case safety reports to the FDA. Taimei Medical Technology’s eSafety pharmacovigilance system also completed the development of its E2B submission functionality during the same period; however, testing and validation were deferred due to the lack of domestic demand at that time.

In 2017, the internationalization of China’s pharmaceutical affairs accelerated, with a rapid rise in demand for Chinese pharmaceutical companies to expand their overseas businesses and an increasing market need for E2B submissions in China. Taimei Medical Technology intensified its efforts, maintaining close communication with officials responsible for electronic submissions to the FDA FAERS system to seek business guidance. In coordination with the relentless efforts and technical breakthroughs of its R&D department, the e-Safety pharmacovigilance system successfully passed the FDA FAERS system testing.

Since then, individual case safety reports in the eSafety pharmacovigilance system can be automatically translated and exported as E2B format files compliant with ICH E2B data standards and message specifications, and directly submitted to the FDA FAERS system.

As a cloud solutions provider in the life sciences sector, Taimei Medical Technology aims to become the most trusted technology solutions provider for the life sciences industry. The success of this test demonstrates Taimei Medical Technology’s alignment with the internationalization trend of China’s pharmaceutical affairs and its commitment to addressing the urgent needs of domestic corporate clients through technological innovation. It also marks a substantial step forward in the internationalization of the eSafety pharmacovigilance system, breaking the long-standing monopoly held by foreign pharmacovigilance systems in E2B electronic submission functionality, filling a domestic gap, and providing new options for Chinese pharmaceutical companies.

The FDA Adverse Event Reporting System (FAERS) is a database designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biological products. The database includes all adverse event and medication error information collected by the FDA. The structure of report data in the FAERS database adheres to the International Council for Harmonisation (ICH) E2B guidelines for electronic transmission of individual case safety reports, and the terms for adverse events and medication errors are coded using the Medical Dictionary for Regulatory Activities (MedDRA).

FAERS is a critical tool for the FDA’s activities, such as identifying new safety issues with marketed drugs and evaluating whether pharmaceutical manufacturers comply with reporting requirements and respond to external information requests.

Once a drug is approved by the FDA for marketing, clinical reviewers from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will evaluate reports of that drug in the FAERS database to monitor its safety.

Upon identification of potential safety issues, further evaluation is required. Such evaluation includes conducting studies using other large-scale databases, such as accessible data from the Sentinel System.

Following the assessment, the FDA will take appropriate measures to enhance drug safety and protect public health, such as updating drug labeling information, restricting drug use, disclosing the latest drug safety information to the public, and, in rare cases, withdrawing the drug from the market.

Adverse event and medication error reports are voluntarily submitted by healthcare professionals and consumers. Healthcare professionals (such as physicians, pharmacists, nurses, etc.) and consumers (such as patients, family members, attorneys, etc.) may submit adverse event and medication error reports directly to the FDA.

Healthcare professionals and consumers may also submit reports of adverse events and/or medication errors to pharmaceutical manufacturers. If a pharmaceutical manufacturer receives an adverse event report, it is required by regulation to submit the report to the FDA. The FDA incorporates both reports received directly and those submitted by pharmaceutical manufacturers into the FAERS system.

MedWatch, also known as the FDA Safety Information and Adverse Event Reporting Program, was established in 1993. It is primarily managed by the Division of Surveillance Research and Communication Support (DSRCS) under the Office of Surveillance and Epidemiology (OSE), which is responsible for managing, collecting, and disseminating information on adverse drug reactions. Through its website and the MedWatch E-list, it releases information on medical product safety, recalls, market withdrawals, and labeling changes to healthcare professionals and the public.

Reports from the spontaneous reporting system are categorized by DSRCS, and different reports are sent to different departments. Data on adverse drug reactions will be sent to the Center for Drug Evaluation and Research (CDER), and the reports will be entered into the Adverse Event Reporting System (AERS).

It is reported that the system enables reporters to clearly identify which adverse reactions should be reported to the FDA; enhances awareness among healthcare professionals and patients regarding serious adverse reactions associated with drugs, biologics, medical devices, combination products, specialized nutritional products, cosmetics, food/beverages, and medical devices; and simplifies reporting procedures to improve review efficiency.

The FDA has spent nearly 35 years collecting paper reports of adverse events. Since 2001, many pharmaceutical companies have voluntarily submitted electronic reports for drugs and non-vaccine biologics to the regulatory agency. Both the collected paper and electronic reports are incorporated into the FDA Adverse Event Reporting System (FAERS).

On August 21, 2009, the FDA published the “Postmarketing Safety Reporting Requirements for Human Drug and Biological Products” in the Federal Register, mandating that applicable firms submit safety reports in electronic format to facilitate FDA processing, review, and archiving. A revised version of this rule was published on June 10, 2014, and became effective on June 10, 2015. This revision helps regulatory reviewers expedite the assessment of safety reports, identify emerging safety issues, and promptly disseminate new safety information to protect public health.

- Spanning the entire pharmacovigilance workflow

- Compliant with the baseline system requirements of Title 21 CFR Part 11

- Compliant with the ICH E2B data interchange standard

- Compliant with GAMP 5 System Validation Standards

- China's First WHODD Dictionary-Certified Supplier

- CDISC System Member and Registered Vendor

- The only PV system integrated with ADR

- The only domestic PV system integrated with the FDA