(Photo credit: Lin Qiang)

A hidden field

Regulatory medical writing is a relatively new profession in China. It’s not that the need for regulatory medical writing didn’t exist in China a decade ago. It’s just that regulatory medical writing itself was not considered a profession until recent years. In the past, most Chinese pharmaceutical companies did not have their own medical writing or regulatory writing departments. Regulatory-related medical writing was often managed by functional unites such as medical affairs.

A new concept

The idea of using professional medical writers to develop regulatory documents was probably first introduced by global pharmaceutical companies striving to enter the Chinese market. Even though these companies had their headquarters-based medical writers to develop documents for global submissions, they still needed local medical writers to generate Chinese regulatory documents and work with the Chinese regulatory agencies. The need for regulatory medical writers who could write in Chinese and understand the local regulations was urgent.

In the beginning, the global biopharmaceutical companies turned to China-based contract research organization (CROs) to help with medical writing-related work. But gradually, these companies, especially those that had set up R&D centers in China, started to build their own medical writing teams in China. As they started to hire and train Chinese medical writers, they introduced the concept of professional medical writing to China. And the profession of Chinese regulatory medical writing emerged as a result.

A growing field

A decade ago, professional regulatory medical writers were few in China, and majority of them worked for global pharmaceutical companies. Today there are hundreds of Chinese regulatory medical writers working for foreign and domestic companies alike. And the number is expected to continue to grow.

In addition to global pharmaceutical companies, CROs and Chinese biopharmaceutical companies including many biotech startups also contributed to the rapid growth of Chinese regulatory medical writing.

Many of these Chinese CROs and biotech startups were founded and are managed by Chinese overseas returnees. Before returning to China, the owners and the management teams of these companies often had worked at global pharmaceutical giants for many years. Many of them have decades of research as well as management experience, and they know the importance of high-quality medical writing documents. When they need to have their clinical study reports written, they look for professional medical writers who can produce high-quality results.

The need for professional medical writers fueled the growth of the medical writing field in China. As more and more Chinese returnees start their own companies in China, the field of Chinese regulatory medical writing will continue to grow.

Currently most of the Chinese medical writers work for biopharmaceutical companies, medical device companies, and CROs. As the field continues to grow and as the first group of medical writers gain more experience, some may choose to freelance or work as contractors. The idea of becoming a freelance medical writer may sound foreign or even scary to many Chinese medical writers right now, but it won’t be so in few years.

A mature profession

The evolving regulatory landscape in China, especially the recent approval of the CFDA as an ICH member, will no doubt help the Chinese regulatory medial writing grow into a mature profession.