Pharmaceutical regulations in Japan are continuously expanding and updating to improve the safety of pharmaceutical drugs. Throughout history, the detection and understanding of harmful side effects of pharmaceutical drugs have led to new enhancements of regulations to allow regulatory agencies to find adverse events more effectively. In turn, this has led to stricter regulations. Likewise, the European Union (EU) and the U.S. (the other two regions of the three global leaders of drug safety) also develop and enhance regulations through similar experiences and activities.
Now, in the drug safety field, new regulations have been harmonized among these regions through the International Council for Harmonization (ICH). For example, the EU has announced that by 2022, the new Clinical Trials Regulation will harmonize the assessment and supervision of clinical trials across Europe via a Clinical Trials Information System (CTIS).
Japanese regulatory authorities are following suit and declared that by 2022, all products used in registered clinical trial protocols would be reportable—even if the product is not manufactured by the company conducting the trial. These new regulations are meant to provide an even playing field for monitoring and supervising clinical trials. In addition, they will provide regulatory agencies and patients with more in-depth knowledge of clinical trial processes and safety.
What does this mean for the Japanese life sciences market? This article will explore the impact of these new regulations and how enterprises can best prepare for compliance.
Japan’s regulatory market
Japan’s pharmaceutical regulations are fairly similar to other developed nations home to multiple life sciences enterprises. The Pharmaceuticals and Medical Devices Agency (PMDA) regulates the Japanese drug market. In recent years, there has been an effort by the international regulatory community to harmonize drug safety information. Japan’s PMDA, European Union’s EMA and the United States’ FDA are three regulatory agencies leading this initiative.
That said, the PMDA still expects companies pursuing regulatory approval in Japan to submit their clinical trial and drug data under specific requirements. All regulatory submissions correlate to specific implementation codes as required by the PMDA, and the text information must be written in Japanese, including any information sourced from company partners. In addition, before the very early adoption of the internationally harmonized electronic submission for adverse event reporting, the PMDA required life sciences companies to appoint a Safety Manager to oversee the entire safety process for regulatory compliance. The Safety Manager is required to sign and stamp any safety case before the regulatory report submissions to show that proper safety protocols and requirements are being followed. Larger companies rely on a digital form approval process, but smaller life sciences companies still depend on manual paper form approvals before their electronic submissions, which can be a problem for companies that submit hundreds of reports each day.
One of the latest regulatory requirements mandates that all products used in a clinical trial must be reported, even if the reported product is not the focus of the trial or owned by the researching company. This will require life sciences companies active in the Japanese market to take a new approach to their clinical trial safety systems and reportings to ensure compliance with both local requirements and other requirements from regulatory agencies around the world.
Integrated PV ecosystems for regulatory compliance in Japan
Pharmaceutical companies possess quality and drug management systems and standards. The PMDA’s regulatory submissions process requires information surrounding products used in trials, regulatory compliance and general information surrounding the clinical trial. The trouble is, many of these processes are siloed functions, which create challenges when it comes to integrating databases and systems for cohesive monitoring and management. If those systems with common data points can be integrated, the accuracy of regulatory and clinical trial information—and subsequent success of regulatory filings—will greatly improve.
In the Japanese pharmaceutical world, safety systems have typically been kept separate from the rest of the world’s regulatory standards due to local requirements. However, today’s major pharmaceutical and life sciences companies typically use a single global database for all operations. Now, the PMDA recognizes this single database approach and is adjusting accordingly. In the future, further integration in cross-functional areas, such as quality, is expected. Integrating quality and safety systems with regulatory intelligence databases and product information will enable Japan and other countries to reap benefits from the connected ecosystems of product safety and quality information.
There are several significant benefits to integrating pharmacovigilance (PV) ecosystems, specifically for the Japanese market. Once regulatory databases become integrated, they can serve as a single source of truth for all regulatory information, allowing organizations to update a single document instead of managing multiple documents in digital and paper formats. In addition, integrated PV ecosystems provide significant financial benefits.
Synchronizing disparate, siloed databases allows for more efficient regulatory filing and control of safety and quality processes. For many organizations, safety, regulatory, and quality processes are completely siloed, have their own budgets, and solely focus on their own duties. Suppose companies can remove those siloes and integrate the separate functions and systems for quality, safety and regulatory. In that case, it will reduce the cost of preparing and submitting regulatory filings, and streamline the process.
Sooner or later, this type of integrated PV ecosystem will be required by every country’s regulatory agency of record. In Japan, one of the major obstacles to adopting integrated PV ecosystems is the fact that Regulatory Information Management (RIM) systems have not yet become standard. However, the recent shifts in both regulatory requirements by Japan’s PMDA and the EU’s regulatory authority are driving transformation shifts in the way life sciences companies manage and prepare regulatory filings. As a result, pharmaceutical companies must recognize the writing on the wall and begin preparing for the regulatory requirements of the future if they want to maintain business activity at planned levels without setbacks due to regulatory non-compliance.
Hisayoshi Charlie Kinemura is a senior director at IQVIA. At IQVIA, Charlie is responsible safety system implementation and strategy of pharmacovigilance technology. Prior to his role at IQVIA, Charlie designed and led the development to introduce Argus Safety Japan while at Relsys, now widely used by a large number of Japanese Pharma companies. Charlie holds an engineer’s degree in computer science from San Diego State University, as well as a bachelor’s degree in economics from Toyo University in Japan.
Filed Under: Drug Discovery, Drug Discovery and Development