Chinese Pharma Regulatory Changes: 3 Implications for the World

Across global industries, China is a burgeoning powerhouse.

The country—with a projected 2019 population of 1.42 billion—is poised to continue disrupting global markets well into the future. One such market? Pharmaceuticals.

The Chinese drug market is undergoing significant regulatory changes that could facilitate more clinical research and drug launches in China. China’s National Medicinal Products Administration (NMPA) has joined the ICH (the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). With that membership, China now follows international pharmaceutical industry practice standards, increasing international harmonization of drug development and clinical trial execution.

Moreover, China has recently restructured its regulatory system, with the aim of encouraging and expediting drug development and release.

These changes are catalysts for growth not just in China, but worldwide.

Here are three implications of the Chinese drug market’s regulatory changes for the world.

1. The Chinese pharmaceutical market’s acceleration presents opportunities for global pharma companies

Already the world’s second-largest pharmaceutical market at $573B, China will keep growing well into the 2020s. Bolstered by its large and aging population, growing per capita income, and increased healthcare expenditures, China has experienced year-over-year growth rates of up to 30%.

Source: Global Business Reports - China Pharmaceuticals 2018

Regulatory changes are now easing burdens for global pharmaceutical companies that have long wanted to sell their products in this promising but widely untapped market. Longstanding Chinese regulatory requirements mandated that clinical trials conducted in China had to include Chinese patients and testing in local laboratories, which compelled pharmaceutical companies to conduct full standalone phase three trials in China only after launching in the US and EU to avoid jeopardizing speed-to-market in these markets.

Now, with these regulatory changes—and with a large, treatment-naïve population well situated for trial recruitment—future trials may occur in China in tandem with US and EU launches. This will be a boon both to Chinese patients, who will receive needed medications more quickly, and to the global pharma companies bringing these medications to market.

In the coming years, it will be interesting to see what effect if any these systemic changes will have on the clinical development planning and regulatory strategies of pharma companies intending to sell their products in China.

2. Regulatory changes may result in fewer redundant clinical trials and less unnecessary risk for patients

With its membership in the ICH, China now follows international GxP standards (e.g., Good Manufacturing Practice or GMP, Good Clinical Practice of GCP) widely adopted in the international pharmaceutical industry. This also means that clinical data generated in China and overseas in ICH territories during drug development will be bilaterally accepted across Chinese and international regulatory authorities.

These changes are important in harmonizing regulatory requirements and facilitating drug development, but they are also key in avoiding redundant or duplicate clinical trials, which expose patients to unnecessary risk. Reforms within the Chinese regulatory system match reforms we’re seeing across global markets: they aim to grant their citizens faster, better access to new and innovative treatments.

3. The volume and pace of clinical trials in China will pick up precipitously

One result of Chinese regulatory restructuring that seems certain is that the volume and pace of clinical trials in China will pick up precipitously in the coming years. Chinese regulatory authorities have made changes that expedite regulatory reviews, implement new and less stringent policies for import of drugs into China, grant market exclusivity periods guaranteed for specific products (e.g., the removal of tariffs on imported oncology drugs), and make significant improvements to the approval timelines of clinical trials in China.

Until now, it has taken between one and three years to obtain approval for a clinical trial in China. That window is expected to drop dramatically—to 60 working days. In principle, this means that trial sponsors can submit applications and execute timelines in both the EU and in China in parallel.

Moreover, the NMPA is implementing priority reviews of certain drugs with the goal of accelerating speed-to-market and facilitating faster patient access to life-saving drugs (e.g., for innovative treatments, advanced technology, or a treatment with significant clinical advantages for diseases such as HIV, tuberculosis, hepatitis, rare diseases, malignant tumors, or pediatric use). The NMPA will also newly accept foreign clinical data for marketing authorization.

These changes encourage new drug development and marketing, opening a world of opportunity to drug manufacturers, trial sponsors, and—most importantly—patients.

Across industries, wise companies would do well to keep their proverbial eye on China. Regulatory changes in the pharmaceutical industry that yield unprecedented opportunity also yield significant challenges for pharma companies seeking to conduct clinical trials and deliver drugs to Chinese markets more quickly and efficiently.

More trials and shorter timelines mean more content, more translations, and more need for a seasoned partner with experience, global reach, and scalability. For years, Lionbridge has been that partner. As always, we’re ready to move into uncharted territory with you, with the joint goal of delivering safer medicine to more people in more places more quickly. Reach out to learn more about how we can help you break into new markets, in China and around the world.