2. 2 Challenges in Implementing Pharmacovigilance Systems

2. 2. 1 Single Route of Access to Data Monitoring

The single access to ADR monitoring data in China has long been criticised, and medical institutions are the main source of ADR reports in China, accounting for more than 80% of the total number of reports (Table 2).

The ADR reporting rate of drug manufacturing and operating enterprises is much lower than that of medical institutions, which is attributed to the fact that public hospitals are responsible for safeguarding people’s life and health rights and interests, whereas enterprises lack public welfare attributes compared with public hospitals, and take negative measures against ADRs for fear that the ADRs may cause the society to question the safety of their products.

In addition, it is worth noting that pharmacists play an irreplaceable role as doctors and nurses in the monitoring of ADR in hospitals, which can make up for the shortcomings of the poor knowledge structure of medical and nursing personnel, thus reducing the risk of medication, and promoting the safety of clinical medication.

However, at this stage, the main occupational source of ADR reporters in China is doctors, occupying more than 50% of the total number of reporters for five consecutive years, and the reporting ratio of pharmacists is only about half of the reporting ratio of doctors (Table 3).

The main reporting channels for ADR reports are limited to medical institutions, which has problems such as poor timeliness and information errors. Medical institutions report ADR occurrences through the spontaneous reporting system, but the lack of data on the actual use of medicines can lead to difficulties in calculating the reporting rate and incidence rate that pharmacovigilance focuses on. In addition, the huge daily workload of medical staff and the fear of disputes may lead to omission and concealment of ADR reports.

Table 2. 2015-2021 ADR Report Sources in Percentage
YearMedical InstitutionsDistributorsManufacturing EnterprisesIndividual
Table 3. 2015-2021 ADR Reporter Categories in Percentage

2. 2. 2 Challenges of Changing Responsibilities and Awareness of Marketing Authorisation Holders for Medicines

Risk alerts and scientific assessment are the shortfalls in China’s pharmacovigilance framework. China has continuously strengthened its system based on the purpose of enhancing and strengthening the awareness of responsibility and risk assessment capacity of Marketing Authorisation Holders (MAHs).

From 2018, the regulator required the MAH to directly report ADRs, to 2019, the MAH was required to proactively collect, monitor, and track and analyse ADR-related information, and then in 2021, the GVP clarified the MAH as one of the important responsible bodies in the field of pharmacovigilance, and imposed requirements on the MAH in building a pharmacovigilance system, and in submitting a risk management plan, and carrying out post-marketing safety studies. The MAH needs to realise the change from “patient accessibility” to “patient safety”, and in this process, it is bound to face multi-dimensional challenges such as manpower and financial resources, monitoring technology and change in the sense of responsibility.

A survey conducted by the Shanghai Adverse Drug and Medical Device Reaction Monitoring Centre shows that more than 90% of the MAH have unilateral and impractical pharmacovigilance procedures, and more than half of the MAH have not set up a special pharmacovigilance department. In addition, the ability and level of pharmacovigilance activities varied according to the size of the enterprises. Although large enterprises are better than small and medium-sized enterprises in terms of professional staffing, application of computer systems, and reporting of adverse reactions, the lack of technical guidance still constrains the implementation of their pharmacovigilance actions.

How to carry out detailed dynamic management and regulations on the pharmacovigilance actions of MAH, effectively open the information sharing and communication platform between MAH and medical institutions, and stimulate the initiative of enterprises in pharmacovigilance work is still an urgent problem to be solved in the implementation of China’s pharmacovigilance system.

2. 2. 3 Regulatory and Monitoring Authorities are Facing a Massive Challenge

Pharmacovigilance covers the whole life cycle of drug safety monitoring environment, and its monitoring work needs to effectively connect multiple regulatory departments from research and development to the use of drugs and even the recall of the whole process.

At this stage, NMPA set up pharmacovigilance department, mainly responsible for the establishment of pharmacovigilance system and supervise the implementation, re-evaluation of drug safety work.

In 2021, China issued the Guidelines for Pharmacovigilance Inspections, which requires drug regulatory departments above the provincial level to inspect the MAH’s pharmacovigilance activities, but there is a lack of mechanism for the delineation of responsibilities for pharmacovigilance within the regulatory departments that are above the provincial level.

Pharmacovigilance is a complex scientific activity that involves both technology and management, and when reviewing and evaluating the risk level of pharmacovigilance deficiencies, the regulatory authority needs the support of scientific committees such as the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).  In addition, pre-marketing ADR monitoring is mainly carried out by the Center for Drug Evaluation (CDE) of NMPA, while the Center for Drug Evaluation (CDE) of NMPA is responsible for post-marketing ADR monitoring, and there is no regular and fixed linkage mechanism between the two, which makes it difficult for the pre-marketing ADR information to better play a role in supporting the post-market evaluation work. it is challenge for the monitoring agencies to collaborate and to establish a mechanism for information sharing and linking, and how they can make use of information technology to improve the in-depth analysis and use of adverse reaction information.

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