Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSThe Japan and Asia-Pacific (JAPAC) region is a rapidly growing biopharmaceutical market that has particularly benefited from the investment of emerging biopharmas (EBPs). In 2018, EBPs made up 80% of all biopharma pipeline projects, accounting for 75% of total clinical trial volume in the JAPAC region. As growth is forecasted to continue, EBPs and contract research organizations (CROs) must define the tools and resources necessary to successfully launch drug programs that meet regulatory safety standards for JAPAC countries.
Both Japan and China have a number of distinct regulatory requirements from their health authorities, the Pharmaceuticals and Medical Devices Agency (PMDA), and the National Medical Products Administration (NMPA), respectively. Unlike most other countries which accept English language resources, both Japan and China require bilingual language proficiency to process adverse events, relay updates to global counterparts, and submit regulatory reports to local health authorities. Furthermore, though all regulatory authorities prefer high compliancy, PMDA and NMPA both have stringent 100% compliance expectations.
For Japan, which has a greater number of regulatory distinctions, other unique requirements include:
To help navigate these nuances and alleviate communication gaps between local and global PV outfits, EBPs will need to hire subject matter experts with bilingual language proficiency or enlist the help of an experienced service provider. If an EBP is just starting out in the region, a service provider’s technology – i.e., translation tools, bilingual safety databases, and robotic process automation – can help ease the transition and ensure seamless compliance.
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was founded in 1990 to promote and protect public health via harmonized regulatory guidelines for regulatory authorities and pharmaceutical industries. Japan’s PMDA serves as a founding regulatory member, while South Korea’s Ministry of Food and Drug Safety (MFDS) joined in 2016, and China’s NMPA in 2017. Since joining, China has adopted 86% of ICH guidelines, and is working diligently to implement those remaining. Japan is leading efforts to implement ICH E17: General Principles for Planning and Design of Multi-Regional Clinical Trials (MRCTs).
In a recent whitepaper, IQVIA experts Hye Jin Choi, R. Ph., Senior Director of Regulatory Affairs and Drug Development Solutions; and Dr. Jayawant Fuke, Senior Director of Lifecycle Safety, break down the progress of ICH guideline adoption in Japan and China, the regulatory nuances for PV in Japan and China, and the strategies pharma companies are leveraging to maintain compliance. To learn more about how to launch a successful drug program in the JAPAC region, download the full whitepaper.
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