On October 21, 2024, the China National Medical Products Administration (NMPA) released a pilot plan that allows non-end-to-end manufacturing of biologics. The NMPA has a longstanding position to require an end-to-end...

On December 30, 2024, China's State Council published a series of policy incentives in Circular No. 53 to stimulate the transformation of the country's life sciences industry.

On February 7, 2014, the China Food and Drug Administration promulgated a notice titled "The Fast Track Approval Process for Innovative Medical Device (Tentative)", effective as of March 1, 2014.

In addition to fines, perpetrators may also face criminal sentences.

The PRC Ministry of Health has proposed to revise the current Measures for Inspection of Medical Advertisement.

The six-year protection applies to innovative drugs and originator drugs, calculated from the date of drug registration. Improved new drugs receive four years of data protection, and first generic drugs receive three years, according to a guideline issued by the administration. Ordinary generic drugs and biosimilars are not granted data protection.

All of the pharmaceutical companies, especially those with business in China, should register their trademarks in China.

The equivalence of the US Orange Book in China, the "CN Orange Book" has been operating since 29 June 2021.

The China FDA has recently promulgated the Provisions on the Food and Drug Administrative Penalty Procedure.

The CFDA expects all device companies to comply with the New GMP and GSP rules as long as they intend to sell the products in China.

药品技术合同的内容并不仅限于技术的开发或转让，往往还涉及到药品的临床试验申报、注册申请、报产审批、质量体系认证以及经销约定等A

Shen said that China and France have maintained close cooperation in geographical indication (GI) for a long time.

2016年5月26日，国务院办公厅出台了《药品上市许可持有人制度试点方案》，在10个省市开展MAH试点。

Chinese State Food and Drug Administration ("SFDA") issued a draft Work Plan for Quality Consistency Evaluation for Generic Drugs ("Work Plan") on November 22 for public comments through December 6.

The new Provisions will strengthen the Chinese pharmaceutical industry, to regulate to fight against commercial bribery.

2017年2月13日，国家食品药品监督管理总局对外发布《食品安全欺诈行为查处办法（征求意见稿）》（以下简称"征求意见稿"），对产品欺诈、食品

On 29 November 2005, the State Intellectual Property Office ("SIPO") of China issued the Measures for Compulsory Licensing of Patents Concerning Public Health ("Measures").

These stipulations were announced by the CN Supreme People's Court on 5 July 2021, one day after the announcement of the NMPA's measures. The announcement is as below...

China's fourth amendment of the Patent Law will come into effect on June 1, 2021.

Transition to the new CN patent law (comes into force on 1 June 2021) was published by the CNIPA yesterday.