The biopharmaceutical market within the Japan and Asia-Pacific (JAPAC) region has grown consistently since 2010, specifically for emerging biopharmas (EBPs). In fact, in 2018, 80% of all biopharma pipeline projects in JAPAC were EBPs, accounting for 75% of the total clinical trial volume in the region. This growth benefits contract research organizations, pharma organizations and patients alike, but several factors must be considered for drug development safety and regulatory operations in JAPAC countries.
Global health authorities in differing regions have varying requirements, so successfully launching a drug program requires in-depth knowledge and expertise of each authority’s specifications. For the JAPAC region, this includes particular quality and compliance standards, as well as cultural nuances. In this context, the key to navigating safety and regulatory requirements lies in understanding the areas that set JAPAC countries apart.
The distinguishing factors
JAPAC countries have unique safety and regulatory distinctions compared to the typical standards of the rest of the world. Unlike most other countries that accept English language resources, Japan and China, for example, require bilingual language proficiency to process adverse event reports, provide updates to global counterparts and submit regulatory reports to the local health authorities. As adverse events are processed within a bilingual database, operational staff within the organization must be proficient in reading and writing. Management staff must share updates with global counterparts, so speaking proficiency is required on their part.
While all regulatory authorities have high standards for quality and compliance, Japan’s health authority, the Pharmaceuticals and Medical Devices Agency (PMDA), and China’s health authority, the National Medical Products Administration, are especially stringent. Both authorities expect 100% compliance from organizations operating within their boundaries
The JAPAC landscape: Requirements in Japan and China
Across the countries in JAPAC, Japan and China are countries with more rigorous compliance requirements. We will dive into some of their processes to illustrate how in the same region the steps taken for compliance differ.
Japan’s PMDA has many safety and regulatory distinctions. In terms of good pharmacovigilance practices, there are three designated roles for the marketing authorization holder (MAH): Souseki, Anseki and Hinseki. This team works together to maintain quality and compliance for an organization. Their main responsibilities include training, self-inspection, detailed recordkeeping and early post-marketing pharmacovigilance, which is required for all newly approved products.
In fact, for six months post-launch, appropriate usage information is shared with medical institutions and any adverse drug reactions are monitored closely. It is the responsibility of the MAH, and the Souseki, Anseki and Hinseki, to ensure work is performed in compliance with both the pharmaceutical company’s procedures as well as regulatory standards. In terms of outsourcing, the service provider is expected to complete annual self-inspections at every operations site.
Furthermore, an in-country clinical caretaker (ICCC) is appointed if the MAH does not have a presence in Japan. The ICCC is responsible for reporting safety information from global clinical trials and post-marketing adverse events to the PMDA. They are also in communication with the sponsor, who is the MAH of the active pharmaceutical ingredient.
In comparison to Japan, China has fewer distinctions. While the country adheres to the guidelines provided by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, there are some additional requirements. The MAH, in this case, must have a designated safety point of contact, and if outsourcing, the requirements for the pharmacovigilance system master file (PSMF) should be fulfilled. Though there is no language requirement for a PSMF, the document is required to be written in Chinese if the product is only marketed in China. For global distribution, a PSMF in English is necessary to avoid repeated translation.
China also requires a local person for pharmacovigilance (LPPV) to ensure consistency at a local level as well as a regional level. As per the LPPV requirements, within the first 30 days of receiving the initial drug approval certificate, the MAH is expected to complete registration in the National Adverse Drug Reaction monitoring systems. Subsequent updates are required to be provided within 30 days of the change date.
Understanding the requirements
For organizations starting in the JAPAC region as an EBP, creating a structure aligned with all local requirements is critical. A staff with bilingual language proficiency will also be extremely beneficial, particularly if the organization plans to move into Japan, as this will eliminate silos and communication gaps between Japanese and global PV counterparts.
It is also key to rely on technology that can handle, manage and analyze large data sets. This enables organizations to bring fully compliant products to market more efficiently. The applications of technology for JAPAC safety and regulatory operations are vast, and these may include:
- Bilingual safety databases support case processing efforts in Chinese and Japanese
- Artificial intelligence-empowered translation tools reduce the time and effort required for manual translation
- Robotic process automation is an asset for foreign case assessment and entry for PMDA reporting
- Workflow management tools improve case allocation, monitoring and compliance
- Narrative automation customizes and creates templates
Technology can be one crucial component for operating in the JAPAC region. By relying on advanced solutions, organizations can successfully launch a drug program with efficiency and accuracy.
Ensuring patient safety and product efficacy while maintaining compliance with regulatory standards is critical, and the right technology and human knowledge of regional nuances can help ease the transition into the JAPAC region.
As the region’s biopharma market continues to rapidly expand, organizations must understand the challenges and different needs of the countries they operate. EBPs will need to plan for success and build strategies that map the unique requirements of the countries in which they are developing different initiatives.
About Hye Jin Choi, R. Ph., Senior Director of Regulatory Affairs and Drug Development Solutions, IQVIA Asia Pacific
Hye Jin Choi joined IQVIA in 2018 and provides regional leadership of Regulatory Affairs and Drug Development Solutions for business expansion across JAPAC. Hye Jin leads the efforts of client engagement and integrated solutions. She interacts with various JAPAC biopharma companies with global drug development ambitions. She also offers regional and global regulatory advisory for proposal strategy development and closely collaborates with IQVIA’s regulatory and drug development leaders to help customers who require regulatory expertise for business in the global markets. Located in South Korea, Hye Jin has over 29 years of experience across the various healthcare industry sectors, including biomedical research institutes, R&D-based biotechs, and global CROs.
About Dr. Jayawant Fuke, Senior Director of Lifecycle Safety, IQVI
Dr. Jayawant Fuke joined IQVIA in 2019 and provides leadership for the JAPAC regions for Safety Operations, Medical Information and Project Management. Jay provides operational and strategic oversight for safety projects in the JAPAC region and works closely to develop JAPAC centric solutions and operational delivery plans. Located in India, Jay has over 16 years experience managing large global deals in pharmacovigilance.