On May 6, 2022, China National Center for ADR Monitoring released the MedDRA Coding Guidance for Drug Marketing Authorization Holders (MAH) (hereafter referred to as Guidance).
MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). It covers registration, documentation, and safety monitoring of medical products for use in both pre- and post-marketing phases of the regulatory process.1
The Guidance is for MAHs to use MedDRA coded terms in post-marketing adverse reaction reports. The reports include the initial reports collected by the MAH itself and from the National ADR Monitoring System. Data in the initial reports, if described by non-standard terms, should first be standardized into "verbatim terms" and then coded into the appropriate lowest level terms (LLT) according to MedDRA Term Selection: Points to Consider (PtC). The data subject to standardization covers disease, adverse reaction terms, and examination items.
Here's an example of reorganizing the disease data2:
(1) Identify the "disease name" in the original report:
Brainstem hemorrhage, stage II hypertension, stress ulcer with bleeding
(2) Describe the adverse reactions:
The patient was hospitalized for brainstem hemorrhage, aspiration pneumonia, and stress ulcer bleeding. Injection A was administered for pneumonia; injection B was administered for stress ulcer bleeding…
(3) Standardize the verbatim terms:
Brainstem hemorrhage, stage II hypertension, stress ulcer with bleeding, aspiration pneumonia
(4) Coding verbatim terms into MedDRA LLTs.
When choosing the MedDRA LLTs, MAHs should make sure the LLT's corresponding high-level term (HLT), high-level group term (HLGT), and system organ class (SOC) that can accurately reflect the meanings of the verbatim terms. MAHs should include the progression of the adverse reactions and avoid relatively less accurate/severe MedDRA terms.
China's MedDRA Coding Guidance manifests that the Chinese drug regulations are getting more aligned with international ones. The standardized MedDRA coding will facilitate the sharing of drug safety data between China and other countries/regions.
