At this time of crisis, our thoughts are with our global community enduring a disease that threatens the lives and livelihood of so many, particularly our most vulnerable.
Our current COVID-19 pandemic crisis will impact us all. A stark reminder that there is no such thing as a local issue, a long standing and widely embraced mantra in the pharmacovigilance global community epitomized by it’s every effort towards global harmonization. The case for international cooperation and collaboration is evidently clear. As China approaches the second anniversary since joining the ICH, we turned our attention to the current challenges and developments in achieving the NMPAs reform commitments towards international harmonization.
Healthcare companies operating in China require a strong skillset in managing change and complexity as they navigate through ongoing regulatory reform along with harmonization to international standards. The challenge is further complicated when you consider international standards are also evolving and the need to address China specific considerations. This includes an imperative to ensure the safe use of new and advanced therapies in a population with an increasing prevalence of disease. Focusing on most recent experiences and developments, we took a closer look at the adoption of the ICH E2B(R3) Guideline on data elements for the transmission of Individual Case Safety Reports (ICSRs).
ICH E2B (R3) format improves the granularity and accessibility of coded data in ICSRs, improving data analysis capabilities and therefore safety signal detection. The submission of expedited ICSRs from clinical trials in E2B(R3) format was mandated in China from May 2019, ahead of many other countries around the world. The submission of post marketing ICSRs in E2B(R3) format is mandated in China from July 2022. Focus is now directed on implementing the new format in the most efficient and effective manner, taking into account local requirements such as the need for translation, local practices such as the use of WHO-ART rather than MedDRA dictionary and China specific data elements. No easy task particularly considering the broader challenges inherent with the global implementation of international standards in an asynchronous manner.
As with many international standards, implementation timelines vary from region to region and often between countries. This asynchronous implementation presents a challenge when a sponsor needs to expedite and distribute ICSRs across the globe in various formats. This is further compounded when there are interdependencies with the implementation of other standards. Multinational companies are at different stages of transitioning from E2B(R2) and may currently submit foreign reports in China with line listings up until 01 July 2020. Service providers in China have developed tools to manage the transition period, including R2 data adjustment applications and data migration capabilities that transcribe line listings to meet R3 format requirements.
China is one of many countries with the need for translation, and with country-specific data elements and proportionally larger case volumes there is a greater need for efficiency and consistency. For domestic reports there is also a need to retain data elements (e.g. drug name, formulation, route narrative, autopsy results etc.) in the local language for local reporting. These data elements are often entered in free text data fields with no standard coding. Local companies also need to translate reports into English for global distribution. Traditionally this has required a growing resource pool of medically trained personnel that are bilingual, along with the use of translation services. More recently, machine learning is increasingly utilized to perform auto translations with improvements in quality and consistency. Specialized service providers have also developed safety databases and capabilities that perform these auto translations that are compatible with Argus/Aris global safety databases for efficient data transfer.
Local companies in China are particularly challenged by the reforms requiring them to adopt emerging international pharmacovigilance standards. This necessitates the implementation and recruitment of advanced pharmacovigilance systems, technology and expertise. This demand has generated a market of local PV service providers with international experience to meet global standards. A growing utilization of local service providers by both local and multinational companies may serve as a catalyst in China’s harmonization efforts, particularly considering the strong network and relationship cultural orientation in China. These partnerships are also likely to increasingly underpin long term success in China.
The challenges, albeit mostly technological for R3, are indicative of the high degree of complexity one must navigate to achieve harmonization. More telling is that solutions are increasingly being met by local service providers with global expertise. They provide a viable support framework for local startups, and are increasingly called upon by multinationals to provide solutions to an evolving landscape. As we have seen in the past those who develop these strong partnerships are best positioned to meet the challenges of a global landscape in an efficient and effective manner.