In 1998, China joined the WHO’s International Drug Monitoring program and started strengthening adverse drug reaction (ADR) surveillance by establishing a comprehensive pharmacovigilance system, including a legal framework, monitoring systems, IT infrastructure, investments, and controls. About 19 years after joining WHO, China officially joined ICH in 2017
as its eighth regulatory member. This is a major step forward for China in achieving global harmonization for providing safe, effective and high-quality medicinal products to its population.
Going further in this path of global harmonization, China adopted several ICH guidelines for safety including ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), ICH E2D (Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting), ICH M1 (MedDRA Medical Dictionary for Regulatory Activities), and ICH E2B (R3) (Electronic Transmission of Individual Case Safety Reports).
The ICH E2B (R3)
guideline adopted by China delineates the requirements for electronic transmission of individual case safety reports (ICSRs) and provides specifications on data elements for reporting adverse events during clinical trials and the post-authorization period. The data structure is based on globally accepted Health Level 7 (HL7[i]
) standards, and the XML schema for ICSRs increases portability.
The drug regulatory authority of China, the National Medical Product Administration (NMPA, formerly CFDA) has set aggressive timelines for drug manufacturers to comply with electronic standards for safety report submissions.
For drug manufacturers, it is mandatory to submit SUSARs in ICH E2B (R3) format from 01 May 2019. Until this time, the reports can be submitted in ICH E2B (R2) format. The SUSAR reports will be accepted by Center of Drug Evaluation (CDE), the subsidiary of NMPA that is responsible for clinical trial regulation.
For ADRs of marketed products, Center of ADR Monitoring (a subsidiary NMPA) will start accepting cases in ICH E2B (R3) format from 01 Jul 2019. Commencing 01 Jul 2022, it will be mandatory for drug manufacturers to submit all post-marketing ADRs in ICH E2B (R3) format.
In order to stay compliant with these requirements, drug manufacturers are required to procure an electronic safety database that is compliant with ICH E2B (R3) format and is capable of generating safety reports as per NMPA requirements. For drug manufacturers who have a local safety officer (LSO) in China and already have a safety database, adverse event reports can be directly submitted to CDE/Center for ADR monitoring databases through an electronic database-to-database transmission. If a drug manufacturer does not have an LSO in China, safety reports can be submitted through one of the several ArisGlobal partner CROs who have a regulatory-compliant electronic safety database system.
ArisGlobal’s LifeSphere Safety MultiVigilance
(formerly ARISg/ARISc) is a single global database system that supports all safety reporting requirements and is fully compliant with Chinese safety reporting requirements, including the ICH E2B (R3) data format. Therefore, the existing LifeSphere Safety MultiVigilance users on the latest version of application are already compliant with these requirements and can transmit cases in ICH E2B (R2) or E2B (R3) formats to NMPA.