01 Nov China, becoming a new power in pharmaceutical industry
Pharmaceuticals can be developed, used or manufactured in any part of the world. China, the world’s second largest pharmaceutical market has become a more mature industry, thanks to the structural adjustment promoted and led by the CFDA (The China Food and Drug Administration). The job to upgrade Chinese pharmaceutical industry and bring Chinese marketed pharmaceutical and device medical products up to international standards has been a constant since 2015.
China’s more global involvement in the pharmaceutical business
Until then, regulatory policies were not only very challenging for foreign pharmaceutical enterprises, but also for local innovative companies. The reform increased the number of reviewers and optimized the drug registration process, creating a priority review channel for selective drug categories (Drug registration acceleration, Opinions on product registration, or Priority approval policy, among others), encouraging new drugs from global pharmaceutical companies to undergo clinical investigation (IND/NDA for drugs urgently needed or severely short in the market), shortening drug delays, and allowing the foreign drug registration process to be changed from submission to approval (Gx applications, Supplementary applications for changed manufacturing process or technology).
The translation clinical studies and other important pharmaceutical content aids drug manufacturers, scientist, and medical staff to improve treatments and patient health. However, it is essential that the information is properly and correctly translated to avoid problems with any country’s regulatory agency. In this sense, the CFDA has recently issued new translation requirements and instructions for medical devices registration in the Chinese pharmaceutical market.
Since 2015 Chinese authorities are bringing Chinese pharmaceutical industry up to international standards.
CFDA enhancing drug quality in China
In order to enhance drug quality, requirements will be increased, especially if documentation and translation are increased due to new clinical trials. This not only affects global enterprises but also those settled in China. No translation mistakes are admitted, not only in China but also when exporting Chinese drugs abroad. Pharmaceutical ingredients and their translation, for example, must be double-checked and fines and sanctions art part of the day to day life.
The critical role of medical and pharmaceutical translation in the Chinese pharmaceutical industry is becoming increasingly apparent as although needed and useful as an initiative to further screen low-quality drug makers, the requirements of current good manufacturing practice (CGMP) regulations do not solve all possible problems or regulations violations.
Depending on the country a bigger or smaller amount of case forms, questionnaires, data sheets, personal information data or consent forms, need to be translated for the specified country’s regulator. The information must be pristinely translated. Any translation error can cause a denial to market a specific pharmaceutical. But this is not all, as market and sales strategies also need to be carried it out in different languages and not only language but culture al values differ from target audience to target audience and from country to country.
The fact that Chinese people preferred to spend 3 times or more on imported drugs, even if they were the same as domestic drugs, was an important milestone for the Chinese administration to make important changes. Now, the CFDA carries out self –inspections to avoid inaccurate and incomplete clinical data in submissions. Quality Consistency Evaluations for generic drug manufacturers were also started in 2016. Manufacturing processes and quality control are now inspected at provincial-level and sales and marketing processes at city-level FDA.
China, encouraging pharmaceutical innovation
Currently, China has a large number of domestic drug manufacturers. Most of them, small to medium size companies which are focused on making generic drugs, including many traditional Chinese medicines. Few manufacturers are actually motivated to invest in innovative new drugs. Some studies point out that about 95% of drugs in China are generic drugs. That is a very different scenery to that of Japan (with 37% innovative drugs), or that of the United States (43% of innovative drugs).
To encourage innovation, the CFDA has also set new policies to change the situation, including prioritizing the review and approval process for innovative drugs, Issuing separate licenses for holders and manufacturers, encouraging local biotechnology and pharmaceutical research institutes to conduct drug development or protecting innovators’ rights.
Pharmaceutical products must go through a localization process. Otherways, they cannot be relevant in an international market. People in different countries have different thoughts, interests, beliefs, languages or likes, and all these features must be considered when targeting any audience, whether national or foreign. The pharmaceutical future in emerging markets belongs to companies that are able to balance their global competences with custom-made approaches for specific local markets.
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