Mondaq Asia Pacific - China: Food, Drugs, Healthcare, Life Sciences
Toby Mak
Supply of generic drugs and their interaction with the patent system, like standards essential patents, present one of the international frontiers of patent protection.
Ropes & Gray LLP
China's drug and device regulator recently announced a set of rules signaling increased scrutiny of foreign drug and device companies.
CO-TALENT
The applicants shall ensure the completeness of clinical trial data.
AFD China
In addition to fines, perpetrators may also face criminal sentences.
Ropes & Gray LLP
The Measures clarify longstanding ambiguities regarding the scope of permitted telemedicine.
Ropes & Gray LLP
On March 17, 2018, the Chinese State Council passed the Scientific Data Administrative Measures (the "Measures") to standardize the management of scientific data at a national level.
Reed Smith (Worldwide)
Following the issuance of the "Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in the Industries of Pharmaceuticals and Medical Devices"
Ropes & Gray LLP
The current MDR requires medtech companies to either conduct clinical studies in China or submit clinical evaluation reports illustrating equivalence to previously approved products
Ropes & Gray LLP
In response to the central government's calling for a data protection mechanism,1 the China Drug Administration (the "CDA") ...
Ropes & Gray LLP
On March 17, China's highest legislative body, the National People's Congress, approved a sweeping government restructuring plan.
Ropes & Gray LLP
China's Government will launch several incentives to enhance accessibility of innovative drugs, especially imported oncology drugs.
Ropes & Gray LLP
On March 17, China's highest legislative body, the National People's Congress, approved a sweeping government restructuring plan.
Ropes & Gray LLP
On January 10, 2018, the China Food and Drug Administration announced the implementation of the Technical Guidelines Governing Acceptance of Medical Device Clinical Data from Foreign Studies.
CMS Cameron McKenna Nabarro Olswang LLP
The draft is open for public comments until 25 November 2017.
CMS Cameron McKenna Nabarro Olswang LLP
On 8 October 2017, the General Office of the State Council issued the Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging the Innovation of Drugs and Medical Devices.
CMS Cameron McKenna Nabarro Olswang LLP
Circular (2014) No.15 provides for the specific deadlines for different domestic medical devices manufacturing companies to gradually meet the Medical Devices Manufacturing Quality Management Standards
HFG Law & Intellectual Property
O Parbleu! Thunderclap for the cheese gourmet! Recently China undertakes strengthened regulatory measures which have directly affected the long-term importation of certain types of European cheese...
CMS Cameron McKenna Nabarro Olswang LLP
The China Food and Drug Administration ("CFDA") promulgated a new circular (2017) No.68 related to the promotion of a drug market authorization holder regime ("MAH Regime") work on 21 August 2017...
Jincheng Tongda & Neal
China has been endeavoring to make comprehensive and fundamental regulatory reform of drug and medical device, in particular in the drug and medical device registration system.
Ropes & Gray LLP
The CFDA is soliciting public comments for these drafts until mid-January 2018.
Most Popular Recent Articles
Ropes & Gray LLP
On March 17, China's highest legislative body, the National People's Congress, approved a sweeping government restructuring plan.
Ropes & Gray LLP
On March 17, China's highest legislative body, the National People's Congress, approved a sweeping government restructuring plan.
Ropes & Gray LLP
China's drug and device regulator recently announced a set of rules signaling increased scrutiny of foreign drug and device companies.
A&Z Law Firm
Lately many restaurants in Shanghai have been broadcasting the work environment in the kitchen at their entrance (in real-time). What is that about?
A&Z Law Firm
On September 24th, Ding Jianhua, director of the China Food and Drug Administration (CFDA) Supervision Department, stated at the 2017 Chinese Pharmaceutical Entrepreneurs, Scientists...
Jincheng Tongda & Neal
China has been endeavoring to make comprehensive and fundamental regulatory reform of drug and medical device, in particular in the drug and medical device registration system.
Ropes & Gray LLP
The current MDR requires medtech companies to either conduct clinical studies in China or submit clinical evaluation reports illustrating equivalence to previously approved products
Toby Mak
Supply of generic drugs and their interaction with the patent system, like standards essential patents, present one of the international frontiers of patent protection.
Ropes & Gray LLP
The Measures clarify longstanding ambiguities regarding the scope of permitted telemedicine.
Ropes & Gray LLP
In response to the central government's calling for a data protection mechanism,1 the China Drug Administration (the "CDA") ...
CO-TALENT
The applicants shall ensure the completeness of clinical trial data.
Reed Smith (Worldwide)
Following the issuance of the "Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in the Industries of Pharmaceuticals and Medical Devices"
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