Andrew Rut, chief executive of MyMeds&Me, writes an Expert View piece on Japanese openings for tech-based pharmacovigilance firms in the wake of regulatory changes.
Japan, one of the most advanced, high-tech countries in the world, is the third-biggest pharmaceuticals market, behind only the USA and China, and it is larger than France and Germany’s pharma sectors combined.
Japan’s largest pharma companies, including Daiichi Sankyo (TYO: 4568), Otsuka (TYO: 4578) and Mitsubishi Tanabe (TYO: 4508), are all global players and some analysts have predicted that 2018/2019 will be a transformative period for the pharmaceutical market in Japan. This is driven by an aging population which has led to greater demand for new drugs, as well as Japan’s stronger links to the global economy and an increased use of generics and moves towards biosimilars.
Opening up the market
To help address Japan’s aging population crisis, promote current pharma companies - both domestic and foreign - and to attract new companies to the Japanese market, the government has eased several life science regulations and accelerated approval of innovative new drugs.
One of the major recent changes for pharma in Japan has been the 2014 revision of the nation’s keystone pharmaceuticals law, renamed the Pharmaceutical and Medical Device (PMD) Act, which covers pharmaceutical and medical devices.
This, according to Japanese officials, has led to drug approvals for certain medicines now being faster than both Europe and the USA – a big change from the days when Japan was seen as a challenging and over-regulated market by foreign pharmaceutical companies.
The PMD Act and other regulatory changes have opened up the Japanese market and led to a number of partnerships, including research and licensing deals involving foreign companies that are keen to enter the dynamic Asian economy.
Examples include America’s Amgen (Nasdaq: AMGN), one of the world’s largest biotechnology companies, forming a joint venture with Japan’s Astellas Pharma (TYO: 4503). In addition, Germany’s Bayer (BAYN: DE), which has a long history in Japan, took advantage of loosening regulations by opening its cutting-edge Innovation Center Japan, in Osaka.
Bayer’s activites also included a two-year collaboration agreement with Kyoto University, which has seen top academics work with the Germany company on its research and development projects.
New importance of PMS studies
In Japan, there has also been a new emphasis on ensuring the capture of meaningful real-world data from post-marketed surveillance (PMS) studies. Previously, these studies have been expensive and inefficient but new regulations are being introduced which focus on the collection of data to facilitate robust benefit-risk assessments.
On April 1, 2019, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will be the first global regulator to make submission using E2B R3 guidelines mandatory.
E2B R3 establishes the new industry standard for the electronic transmission of adverse event information between pharma companies and regulatory authorities globally.
E2B R3 will ensure that better, more standardized data is captured as the regulation introduces new and updated data requirements including better control of causality assessments for Individual Case Safety Reports (ICSRs), which now mandate the use of controlled vocabularies for source, method and result of assessment; added capability to submit Amendment Reports if case information has changed; a tracking system which enables the moving of information tracking from case level to event level to allow for variations from case-to-case depending on the severity of the adverse events, medical requirements and the occurrence; and the implementation of ISO Identification of Medicinal Products (IDMP) Standards, which introduce additional date fields and codes for the identification of medicinal products.
It is imperative that good, reliable and standardized data is collected during post-marketing surveillance and during real world use. Capture of data as close to source as possible through digital tools, such as the cloud-based multi-platform safety data capture tool Reportum, ensures data accuracy and completeness while simultaneously routing the data for rapid evaluation.
Japan is closely following the risk management planning processes driven by Europe and the USA with the recognition that proactive and robust data collection is essential to understanding the intrinsic and extrinsic factors affecting the safety and efficacy profile in Japan. Thus, post-market surveillance programs are moving away from a ‘tick box’ requirement to providing a platform for the healthcare system to determine the true profile of medicines in the Japanese population.
With such monumental shifts in the market, there are clear and immediate opportunities for companies on the cutting edge of pharmacovigilance to help the Japanese pharmaceutical industry to be compliant, incorporate best practice and to deliver the new drugs and treatments that the country’s population needs.
Source : https://www.thepharmaletter.com/article/look-east-why-tech-based-pharmacovigilance-firms-are-looking-to-japan-for-new-opportunities