NMPA released the Guidelines on the Collection and Reporting of Individual Adverse Drug Reactions (Draft for Comment) (“Draft”) on 7 September 2018. It is open for public comment until 20 September 2018.
According to the Draft, the individual Adverse Drug Reaction (“ADR”) refers to the adverse drug reaction suffered by an individual patient who takes the drug. Reports on the individual ADR refer to an individual ADR report which has been filled in by a Market Authorisation Holder3 (“MAH”) in accordance with the requirements of the authority.
- The collection of the individual ADR information
The MAH has the legal obligation to collect the individual ADR information from doctors, pharmacists, medicine retailers, complaining calls, academic publications, the Internet and other sources.
- The response to the individual ADR
The MAH should objectively, truthfully and accurately record the individual ADR information. To make a valid report, the MAH must record four necessary elements: the identifiable patient, the identifiable reporter, the problematic drug and the adverse drug reactions. The MAH should confirm the aforementioned information and report it to the authority.
- The analysis of the individual ADR
The authority will analyse the received report. If the ADR is different from the descriptions of the drug instruction, it will be defined as a new adverse drug reaction. If the ADR causes death, threatens lives or causes other severe medical accidents, it will be defined as a severe adverse drug reaction. In addition, the authority will analyse the causation between the problematic drug and the patient’s reaction in accordance with the guidelines of the World Health Organisation.
- The reporting of the individual ADR
The individual ADR report should be submitted through the specific supervising system designated by the authority. The report must be submitted within the designated time period. If the MAN submits the report outside China, the time period will starts from the time that it knows such individual ADR information.
- The follow-up investigation
If the individual ADR information first received is not complete, the MAH should make further investigation by mail, email, telephone or other approaches. For those ADRs causing death, the MAH must conduct an investigation on the conditions of the patient, the use of drugs, the occurrence of adverse drug reactions, diagnosis and treatments, etc.
- Data management
The MAH should keep all of the data (including the original ADR recording, follow-up investigation, etc. no matter it is in the electronic or hardcopy format) true, complete, secure, confidential and traceable during the whole life-circle of the medicine.
Although the Draft has not taken effect yet, it indicates the possible upcoming changes on the ADR regulatory regime.
To download the full text of the Draft (in Chinese only), please click here.