The Chinese biopharmaceutical industry has experienced tremendous growth in the past decade. Behind the rapid growth co-exits two driving forces. One is global pharmaceutical companies continuing their investment in China, and the other is a growing number of Chinese companies that are striving to make marks in their homeland.

However, global and domestic biopharmaceutical companies  often face unique challenges in China. One of the challenges is the uncertainty of Chinese drug regulations.  The ever-changing rules, plus the lack of clear guidance, often cause headache to foreign companies and domestic companies alike.

However, things started to change in June, 2017.

Joining the ICH

On May 31 to June 1, 2017, the International Council for Harmonization (ICH) gathered in Montreal, Canada. During the meeting, the ICH Assembly approved the China Food and Drug Administration (CFDA) as a new regulatory member. The approval marks a significant milestone in China’s pursuit of regulatory modernization. It also provides tremendous opportunities as well as challenges for pharmaceutical companies in China.

Collaborating with the FDA

The CFDA and FDA have gradually enhanced their collaboration in the past decade. CFDA’s participation in the ICH will no doubt further improve the relationship between the two agencies. Early this year, an FDA delegation led by FDA’s Theresa Mullin visited the CFDA and held a meeting with CFDA Minister Bi Jingquan. And later this year, the CFDA plans to visit FDA to continue their collaboration on regulatory modernization.

Meanwhile, the Chinese Center for Drug Evaluation (CDE) is leading an effort to translate many of the FDA’s guidelines into Chinese. The translation will serve two purposes. One, the translated documents will help the officials of the CFDA and CDE to learn the lessons and experiences accumulated by the FDA. After all, both regulatory bodies have faced and are facing similar challenges. Two, the translated documents will be of great help to Chinese pharmaceutical companies that are planning to bring their products to global markets.

The recent changes in the Chinese regulatory landscape will inevitably affect many functional areas of the pharmaceutical industry. Along with manufacture and clinical trial management, medical communication, especially regulatory medical writing, will face drastic changes.

In the following posts, we’ll discuss the potential opportunities and challenges affecting the biopharmaceutical industry in China. And we’ll start with trends and opportunities of scientific medical writing in China. So stay tuned.