By Berry Pan, GBI Analyst
The Ministry of Health of the People's Republic of China (NYSE:MOH) recently revised its Provisions for the Administration of Adverse Drug Reaction (ADR) Reporting and Monitoring (MOH Order No. 81: May 4, 2011), establishing a new safety administration paradigm for post-marketing drugs. This set of rules, which takes effect July 1, 2011, is the most recent in a series of measures the authorities are implementing to enhance the protection of human subjects and to improve pharmacovigilance and risk management standards.
The previous version (MOH/SFDA Order No. 7: March 4, 2004) – itself the revision of a draft policy document (Guo Yao Guan An No. 401: 1999) dated November 25, 1999 – had been seen as impractical and toothless. But since its release, the international PV environment has evolved and multiple safety concerns have arisen in China. The State Food and Drug Administration (SFDA) had solicited comments in response to the draft issued June 30, 2009, whereupon local industries, authorities and MNCs pointed out significant gaps in existing PV frameworks. Speaking on behalf of most MNCs in China, the RDPAC working group complained about difficulties in harmonizing local requirements with global standards, including privacy in case reporting and aggregative report format/timeline. For their part, local companies bemoaned the challenges presented by their inadequate budgets and staffing. Therein lies the challenge for the Chinese authorities: Balancing the urgent need for improved drug safety with the inherent hardship caused to industry stakeholders. Ultimately, the MOH executive committee approved a heavily-amended document on December 13, 2010, which Health Minister Chen Zhu signed on May 4, 2011, with effect from July 1, 2011. The highlights of MOH Order No. 81 are as follows:
l Clarification of roles and responsibilities of the SFDA, the National Center for ADR Monitoring (NCADRM), the Provincial Center for ADR Monitoring (PCADRM), manufacturers, suppliers, hospitals and individuals;
l Requirement for independent PV organizations, systems and staff at each manufacturer, including more proactive safety monitoring standards;
l Define and distinguish the Local Individual Case Safety Report (ICSR), the Multi-Case Report, the Overseas Case Report for import products (CIOMS II Line Listing) and the Periodic Safety Update Report (PSUR);
l Mandate archiving and documentation within PV systems;
l Description of PV activities associated with drug re-registration; and,
l Outline of the compensation concept.
Nonetheless, the above do not paint a complete picture. The Chinese authorities must give still greater consideration to international harmonization, electronic case reporting standards and the overall flexibility of these provisions. Specific examples include the CIOMS I form, which is widely accepted globally, but is not yet officially recognized in China, and IBD, which may conflict with definitions within this provision. Further, MNCs must devote significant resources to translation and synchronization, and several onerous provisions in the new document clash with the existing National Adverse Drug Reaction Monitoring Network, creating cumbersome operational issues. The electronically automated capture and exchange of safety data between separate entities presents another significant challenge.
Overall, Provisions for the Administration of Adverse Drug Reaction (ADR) Reporting and Monitoring is but a new beginning for Chinese pharmacovigilance. All industry participants must earnestly address the issues and seek to adapt their operations to real-world standards, whether in post-marketing drug safety, clinical trial safety or pre-clinical PV.
 MOH Order No. 81: May 4,2011; SFDA: sfda.gov.cn/WS01/CL0053/62621.html
 MOH/SFDA Order No. 7: March 4, 2004; SFDA: sfda.gov.cn/WS01/CL0053/24477.html
 Guo Yao Guan An No. 401: 1999; SFDA: sfda.gov.cn/WS01/CL0058/9305.html
 Shi Yao Jian An Han No. 61: 2009; SFDA: sda.gov.cn/WS01/CL0055/39654.html
 CIOMS, Council for International Organizations of Medical Sciences: cioms.ch
 National Adverse Drug Reaction Monitoring Network: adr.gov.cn