Regulatory Brief

Registration of Drugs and Medical Devices Adjusted, Supply Chain Innovation Promoted – China Regulatory Brief

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China to adjust registration management for drugs and medical devices

To promote the adjustment of industrial structure and technological innovation in the drug and medical device sector, the Communist Party of China’s Central Committee and the State Council jointly released a guideline on the reform of the review and approval system, which came into effect on October 8, 2017.

The guideline lays out several primary objectives. These include overhauling the management of clinical trials, accelerating the drug and medical device approval process, promoting drug innovation and the development of generic drugs, enhancing the administration of drug and medical devices throughout the product life cycles, and improving technical review infrastructure for greater transparency and oversight.

Notably, the guideline stipulates that qualified overseas clinical trial data can now be used in the drug and medical device registration and approval process. In the face of a grave threat to public health, drug and medical device registration approvals shall be fast-tracked. In addition, a rare disease catalogue will be set up and new products that can treat these rare diseases could be eligible for reduced trials.

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US Asks China Not to Implement Cybersecurity Law, NEV Production Quotas Released – China Regulatory Brief

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US requests China not to implement Cybersecurity Law

The US has requested China not to implement its controversial new Cybersecurity Law, according to a document published by the World Trade Organization (WTO) on September 26. Many foreign governments and business organizations have also expressed unease at the law, in force since June 1 this year, due to its data localization provisions, restrictions on the cross-border flow of information, and government security reviews.

While the Cyberspace Administration of China (CAC) did not delay implementation of the law, it gave businesses a grace period lasting until December 31, 2018 to comply with the cross-border data flow requirements.

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IP Protection Campaign Launched, Medical Device Classification Catalogue Revised – China Regulatory Brief

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12 national departments jointly launch campaign on IP protection for foreign enterprises

12 national departments, including the State Intellectual Property Office (SIPO), the Ministry of Public Security (SPB), the Ministry of Commerce (MOFCOM), the General Administration of Customs (GAC), the State Administration of Industry and Commerce (SAIC), and the Supreme Court and the Supreme Procuratorate have issued a joint action plan to protect intellectual property (IP) held by foreign businesses.

According to the action plan, the authorities will conduct a special operation from September to December 2017 to crack down on the theft of trade secrets, trademark infringement, patent violations, and online property rights violations.

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Supreme Court Issued Interpretation IV on Company Law, ICOs Banned – China Regulatory Brief

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Interpretation IV on Company Law enhances shareholder protection

China’s Supreme Court issued the fourth judicial interpretation of the PRC Company Law (“the Interpretation”) at a press conference on August 28 to further standardize company governance, and enhance protection to the minority shareholders and creditors, with effect from September 1, 2017.

The Interpretation offers great practical and instructive guidance to the law application issues in disputes over the validity of company resolutions, shareholders’ right to know, profit distribution, preemptive right, and shareholder representative action.

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Anti-Pyramid Scheme Campaign, Long and Unusual Company Names Banned – China Regulatory Brief

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China initiates a three-month campaign to combat pyramid schemes

The government launched a three-month campaign against pyramid selling after the death of a Chinese university graduate in Tianjin caused by involvement in a pyramid scheme.

China’s State Administration of Industry and Commerce (SAIC), along with the Ministry of Public Security and the Ministry of Education will work together to investigate recruitment methods multi-level marketing firms use to target graduates and new job seekers. Violating networks and entities engaged in such activities will be disbanded and charged.

Pyramid selling schemes have increased over the last few years mainly through social networks, with over 20,000 cases investigated by the Chinese police over the 10 year period from 2005 to 2015. The authorities seized RMB 990 million (US$148 million) over the course of the inquiry. In 2016, 2,826 cases were investigated, an increase of 19.1 percent from the previous year.

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Filing Rules for FIEs Revised, Customs Clearance System Reformed – China Regulatory Brief

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All online payments to be processed via a centralized clearing platform

The People’s Bank of China (PBOC) has released regulation which stipulates that starting June 30, 2018, all online payments made in China linked to bank accounts will be processed through a centralized online payment clearing platform.

This will allow financial regulators to protect consumers and strengthen risk control over the third party payment industry as the current system allows such institutions the possibility to misuse consumers’ settlement reserves. Settlement reserves are paid by customers to process authorized transactions before the delivery of goods is made.

The frequency of misappropriation of consumer payments have increased in the past few years with the rise of the e-commerce sector, most commonly being used as working capital invested in high risk projects or wealth management projects, causing significant losses for consumers.

The new regulation will cut out the possibility of funds misappropriation, and circumvent inefficient payment settlement processes.

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