Regulatory Translations for Drug Approvals in China
There’s a growing demand for English to Simplified Chinese regulatory translation services to comply with China’s new foreign drug approval process. There’s also an increased demand for translation of Safety Data Sheets (SDS) from English to Simplified Chinese. Interestingly, patent law was non-existent in China up until 1985. To this day, China puts myriad bureaucratic roadblocks in the way of approving disease-curing and life-saving drugs, and other pharmaceutical devices. Indeed, Chinese patients have fought for decades to get access to cutting-edge medicines, but were rebuffed by highly complex and rigid rules in the country.
That is all set to change due to China’s changes to its pharma IP rules.
Several months ago, China’s State Council made a number of proposals that will represent a sea change to the way in which drugs are approved in China. In fact, the proposals have massive implications for the future of drug and device development in China.
Simplified Chinese Translations of Foreign Clinical Data
First and most notably for multinational drug companies, China proposes accepting clinical trial data generated overseas. Currently, multinational pharmaceutical companies need to run expensive and time-consuming Chinese clinical trials of their drugs and other products in order to market the products in China. The proposed change, however, will allow companies to use already established clinical data when coming to the Chinese market. It goes without saying that this will generate a need for translating the foreign clinical data to Simplified Chinese. The only caveat is that the overseas clinical trials need to address ethnic differences, so that Chinese patients are factored into the data.
In addition, China’s State Council made other proposals to expedite approval of drugs in the country. Specifically, the proposals built on the Chinese Food and Drug Administration’s (CFDA’s) recent efforts to move the country toward a clinical trial approval system similar to that of the United States. Such efforts include:
• Faster processing of drug approval applications,
• Focusing on China’s legal and regulatory systems to identify and prosecute data fraud, and
• Aiding developers of innovative drugs by protecting intellectual property.
The Real Winners From These Proposals
The proposed drug approval changes in China are viewed as a real growth opportunity for multinational pharmaceutical companies. China is the world’s second largest pharmaceutical market. Therefore, faster approvals of drugs in China can lead to a significant increase in revenue for Pfizer Inc., GlaxoSmithKline PLC, and other multinational drug companies.
Accordingly, multinational drug companies will be beneficiaries of the proposed changes in the short term. However, over time, Chinese local drug makers will be able to effectively compete given their knowledge of the local market and lower costs.
Changing China’s Image in the Enforcement of IP Laws
For many years now, China has been viewed with derision when it comes to intellectual property. There are many examples in which Chinese companies overtly stole the intellectual property of foreign companies. Such examples of Chinese IP thievery include fake Apple stores and Chinese cars that are so similar to American- or British-made cars that some of the parts were interchangeable.
China’s recent emphasis on protecting IP rights of companies inside and outside China, however, have gone a long way to change China’s image in the world. As China continues to update and strengthen its enforcement of IP laws, foreign companies will begin to view China as a fair arbiter of IP disputes.
English to Mandarin Chinese Technical Translators You Can Rely On
China’s choice to join the rest of the world when it comes to protecting intellectual property rights means that business between foreign companies and Chinese government functions, be they regulatory bodies or IP courts, will likely increase dramatically. That will signal a sharp demand for English to Mandarin Chinese translators who specialize in technical translation services.
Taking the example of China now accepting foreign clinical trials for drugs, it is clear that if China is poised to accept foreign clinical data, the data must be translated to Simplified Chinese. Of course, clinical trial data can be highly complex, and requires precision in translation because of the importance of the data in obtaining final drug approval. That is a job for a professional, high-quality English to Mandarin Chinese technical translation service.
When the stakes are so high for your business, and you want to ensure that your company’s drug application is approved, you need to have a medical translation service you can rely on. We specialize in Chinese translations of technical data, legalese and pharmaceutical documents.
Contact All Language Alliance, Inc. to obtain English to Simplified Chinese translations of clinical studies protocols, final report, informed consent and package labeling.
Our English to Mandarin Chinese technical translators understand cultural references, cultural differences, and shades of meaning so we can ensure that the technical information your company needs to impart is clear to the Chinese reader. We pride ourselves on quality, and we pride ourselves on getting it right the first time. Go with a Mandarin Chinese translation service that has the sophistication to help you with all types of technical documentation for doing business in China– clinical trial data and legal documentation. We can guarantee you will be a satisfied client.
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