Regulatory Changes in China Likely to Affect Demand for Analytical Instruments

According to China’s FDA (CFDA), the State Council issued two five-year plans on food and drug safety earlier this year that will impact analytical instrument manufacturers. In regards to food safety, violation laws and quality standards will be much stricter, with over 300 national standards for consumer foods, agricultural products and pesticides to be issued between now and 2020 in the hopes that China’s standards will meet international standards. The government plans to quicken the implementation of protection from soil contamination, and grain and fertilizer management legislation, as well as ensuring that sample tests cover all types of food, specifically with testing for pesticides and veterinary drugs. According to the plan, 97% of agricultural products are required to meet quality standards by 2020. Overusing food additives, incorporating industrial ingredients in consumer foods, falsifying expiration dates and undertaking misleading advertising for healthy foods will be punished more severely. In addition, the supervision of food production, new business models (i.e., food e-commerce and online ordering), and export and import laws will be increased.

The plan on drug safety states that pharmaceutical drug quality is to be improved, calling for the approval of 289 generic drugs, as well as the reform of 3,050 national drug standards and 500 medical equipment standards by 2020. This will ensure that the new rate of periodic drug safety reports will reach 100%. To achieve this target, the Council urges that quality evaluations for generic drugs should be endorsed, drug manufacturing and production should be better supervised, medical treatment approvals should be re-examined and drug standards regulations should be improved. To ensure better quality evaluation of drugs, the plan states that manufacturers should engage in more R&D and analysis, as well as improve supervision of market supply and usage. Businesses will be asked to send quality evaluation reports of new drugs to the CFDA before the end of January of each year. The plan also encourages the pharmaceutical industry to develop an online approval system to strengthen the local and national drug quality evaluation system, focusing on lab and coastal testing centers, and biological products. Stricter punishments will also be implemented for pharmaceutical-related incidents.

How Chinese scientists believe the changing regulatory environment will impact their instrument purchasing plans is just one of the many topics explored in our latest report, The Analytical & Life Science Instrument Market in China: Dispatch from the Middle Kingdom.

This report covers all of the same instrument categories as our Global Assessment Report but is focused exclusively on the nearly $6 billion Chinese market which we expect to grow at 5.8% over the next five years. We report on the current macroeconomic environment in China and recent developments impacting multiple industries where analytical instruments are used. Market size and growth is projected for each class of instrument out to 2021. In addition, we fielded a survey in Chinese and 372 scientists told us about their awareness and use of major global and Chinese brands of instruments, their funding levels, future purchasing plans and more.

You’re invited to download the Executive Summary with a Table of Contents here.

Parts of this article were originally published in the March 1, 2017/in Volume 25, Issue 22 of our executive newsletter, Instrument Business Outlook.