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Breaking News on New Policies of Innovative Drugs in China

An executive meeting of the State Council of China was held on April 12, 2018 and presided by Premier Mr. Li Keqiang. According to the meeting, a series measures will be taken to encourage the importation of innovative medicines into Chinese market, to enhance intellectual property protection, and to lower medicine price. The measures include exemption certain medicines from customs duty, reduction of drug price, expedition and optimization of the process for authorization on the commercialization of imported innovative medicines, enhancement in intellectual property protection, and augmentation in quality monitoring.

It is worth noting that, the measures on enhancement in intellectual property protection is exciting for innovative medicines and pharmaceutical companies. The data exclusivity period for innovative chemical medicines is 6 years at maximum, and medicines of the same species will not be authorized to commercialize within this period. In addition, a maximum of 5 years’ compensation of patent term will be offered for innovative new medicines which are applied for commercialization on domestic and oversea markets simultaneously.

Undoubtedly, the above is good news for pharmaceutical companies. But the specific rules on how to determine the duration of the data exclusivity period and patent term extension have not been available. We will keep you informed of the updates in the future.

With the availability of these measures, it is expected that more innovative medicines will be imported into China in the future, and the intellectual property protection for innovative medicines will be enhanced.

Please find the specific information announced by the official authority.

1. Exemption from customs duty

China will exempt all normal medicines including anti-cancer medicines, alkaloid medicines with anti-cancer effect, and Chinese traditional medicine with actual import from customs duty, and to realize a zero customs duty for all anti-cancer medicines.

2. Reduction of drug price via comprehensive measures

Comprehensive measures will be explored. Manners include, for example, centralized purchasing by the government, timely incorporating imported innovative medicines particularly anti-cancer medicines with urgent desire into the category of medical insurance, research on oversea online channels, and the like, so as to make the public realize that the price for urgent desired anti-cancer medicines is significantly reduced.

3. Expedition the commercialization of imported innovative medicines

Application for clinical trials will be amended from the manner of authorization to duly default approval. Chemical medicines will be imported with the support of testing results of enterprises, and compulsory testing by batch is not necessary any more.

4. Enhancement in intellectual property protection

The data exclusivity period for innovative chemical medicines is 6 years at maximum, and medicines of the same species shall not be authorized to commercialize within this period. In addition, a maximum of 5 years’ compensation of patent term will be offered for innovative new medicines which are applied for commercialization on domestic and oversea markets simultaneously.

5. Augmentation in quality monitoring

Quality monitoring of imported medicines will be enhanced. Inspection on the oversea manufacturing sites of imported medicines will be augmented. Severe measures will be taken towards the activities of manufacturing or selling false medicines.