Opportunities and challenges coexist in my country's pharmaceutical foreign trade in 2022

In the past two years, driven by the demand for prevention and control of the new crown pneumonia epidemic, China's pharmaceutical foreign trade has grown rapidly, becoming one of the main driving forces for the stable growth of China's foreign trade, and has played a key role in stabilizing foreign trade and foreign investment
.
However, the current new crown pneumonia epidemic is still spreading, the international situation is still changing, the development of pharmaceutical foreign trade is facing many risks and challenges, and there are many uncertainties in the future situation
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First of all, the uncertainty brought about by the new crown pneumonia epidemic is still the biggest variable in China's foreign trade in medicine in 2022
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On the one hand, affected by the spread of the Omicron variant, the scale of new coronary pneumonia infection has further expanded; on the other hand, the increase in the vaccination rate of the new coronavirus and the emergence of oral therapeutic drugs have brought dawn to the effective control of the epidemic
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However, some countries and regions have already announced the relaxation of all epidemic control measures, which will lead to a surge in the number of infections
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The spread of the epidemic may slow down the decline in the export of China's anti-epidemic materials, and the relaxation of control means that these countries and regions will resume work and production on a large scale, and the rigid demand for China's anti-epidemic materials will decrease
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Secondly, inflation, the continuous appreciation of the RMB and the sharp rise in logistics costs have brought enormous pressure to foreign trade
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In the past two years, in order to accelerate economic recovery, most countries and regions in the world have implemented monetary easing policies.
The subsequent rise has pushed up the cost of China's pharmaceutical production
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The continuous increase in the exchange rate of RMB against the US dollar also has a great impact on the export of China's pharmaceutical products, especially on the manufacturers of raw materials and low-end medical devices that rely on price advantages to compete for overseas markets
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In addition, affected by factors such as cross-border logistics, manpower and epidemic prevention costs, it is common for companies to increase their export revenue without increasing their profits
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Third, international political and economic frictions and black swan events continue
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Political and economic and trade frictions with China provoked by some countries have brought a certain negative impact on my country's pharmaceutical exports
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For example, the United States requires a series of measures to ensure the safety of its domestic drug supply chain and reduce its dependence on APIs in other countries and regions; India has initiated more than ten anti-dumping investigations on APIs and pharmaceutical intermediates in China to support the development of its own API industry
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The confidence of Chinese enterprises in exploring overseas markets has been hit, and some projects have had to be suspended or cancelled
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Finally, domestic and foreign supervision has become stricter, and enterprises are facing dual regulatory pressures
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Internationally, the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) will be implemented in May 2021, with new regulations focusing more on clinical performance, enhancing the traceability of medical devices and improving transparency for patients
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Generally speaking, with stricter regulations and stricter procedures, many companies queuing up to apply for EU CE certification are facing the problem of re-registration, which will bring problems such as increased costs, longer certification cycles and increased compliance risks to Chinese export companies; Although the US FDA has resumed normal inspection work in July last year, it still has a backlog of overseas drug production inspection projects, and the FDA has not vigorously promoted remote inspection methods.
It is expected that the inspection queue will not be fundamentally alleviated in 2022, which will This has hindered the plans of some Chinese pharmaceutical companies to develop the US market
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Domestically, the regulatory laws and regulations on drugs, medical devices, and cosmetics are becoming more and more perfect, and the requirements are getting higher and higher.
The implementation of the medical device registrant system, the adjustment of the medical insurance drug catalog, the expansion of volume purchases, and the anti-monopoly of raw materials, etc.
Operation has put forward higher requirements
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Even in the face of many risks and challenges, the multiple support and guidance of China's government policies, the solid foundation and resilience of industry enterprises are the "Dinghaishenzhen" that promotes the steady development of China's pharmaceutical foreign trade
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At the end of 2021 and the beginning of 2022, the "Implementation Plan for Promoting the High-quality Development of the API Industry", "The 14th Five-Year Plan for the Development of the Medical Equipment Industry" and "The 14th Five-Year Plan for the Development of the Pharmaceutical Industry" have been successively released, which will help the upgrading and development of my country's pharmaceutical industry.
specified path
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In January this year, the General Office of the State Council issued the "Opinions on Doing a Good Job in Cross-Cycle Adjustment and Further Stabilizing Foreign Trade", which proposed 15 measures to support foreign trade enterprises to reduce costs, create a more convenient environment for foreign trade, and promote the stable development of foreign trade.
Trade provides more support
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China has put forward a new development strategy for the new era, and is moving towards a more in-depth and higher-level reform to further raise life and health issues to an unprecedented strategic height.
The international status of China's pharmaceutical industry will be further enhanced
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(This edition is contributed by the China Chamber of Commerce for Import and Export of Medicines and Health Products, the main writer: Zhu Renzong)