Putting China on the global map with regulatory standardization

China has been making significant strides to become a global pharmaceutical force. A massive breakthrough came in June 2017 when the country was accepted as a member of the International Council for Harmonization (ICH), joining the global club that consists of the United States, Europe, Japan, Canada, Switzerland, Brazil and Korea.

Chinese pharmaceutical companies are eager to compete in the international arena and to speed the process of getting drugs onto domestic and global markets. Membership in ICH is a first important step in China’s commitment to reforming its drug regulations; the next step will be for Chinese companies to bring their regulatory processes and submission standards in line with international norms.

China’s membership in ICH, its implications and the potential market opportunity it presents — both for companies looking to market their products in China and Chinese companies seeking to enter global markets — was one of the hottest topics at the Drug Information Association’s (DIA) annual meeting in Chicago in June. Almost half a day was spent talking about the Chinese government’s approval process, what the China Food and Drug Authority’s (CFDA) expectations are, and how Chinese pharmaceutical companies will prepare for entry into new markets.

CDISC adherence

One of the major requirements for Chinese companies seeking to bring their products to major markets, including the United States, will be adherence to Clinical Data Interchange Standards Consortium (CDISC) standards. The challenge is that even today, Chinese pharmaceutical companies are typically not collecting clinical data in a standardized way, so there are many obstacles for companies to overcome.

Over the past several months, we have received many inquiries from companies seeking to format their Chinese dossiers to ones that would meet U.S. Food and Drug Administration (FDA) requirements. But it’s clear that most companies aren’t aware of the complexities involved. It requires far more than a simple translation from Mandarin to English. Consider, for example, abbreviations such as AE (adverse event). Translating a document that included adverse events would require physician expertise as well as that of a CDISC expert.

Chinese companies can, however, take some early steps to ease the transition and prepare for entry into new markets. They should start by focusing on the language barrier to determine whom they will need to include in preparing their documents and what can be done early on to limit complexities. The legal system is also a source of complexity, since the legal requirements differ from one market to the next. Therefore, having expertise in this area is important.

The third crucial element is preparing regulatory guidelines for submissions, not only within China but also for submission to international regulatory authorities, including the European Medicines Agency (EMA) and the FDA.

Once these requirements are in place, companies need to ensure that they either have full external support to meet the CDISC standards, or that they have trained their own programmers on CDISC to move their legacy data from previous formats into standardized, submittable formats.

There is another way forward for Chinese companies, and that is to engage a partner with expertise in all areas of product submission, including clinical data conversion to CDISC formats, and with global scope to support companies during their transition. Ideally, a partner should have presence in China to help local companies transition to ICH regulatory standards.

Learn how DXC can provide a bridge for bringing Chinese pharmaceutical submissions to new markets, as well as helping global companies enter the Chinese market by providing regulatory expertise, data conversion and training in CDISC standards and other regulatory requirements. Visit DXC Life Sciences.

Han Zou is manager of Life Sciences Biometrics at DXC, and Rao Mandava is CDISC Lead at DXC.

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