China recently announced two revised decrees that, once implemented, would impose substantial new requirements for food and beverage companies that export to China. These regulations are as follows: In particular, with some...more
6/15/2021
/ Beverage Manufacturers ,
China ,
Customs ,
Exports ,
Food & Drug Regulations ,
Food Manufacturers ,
Food Supply ,
Foreign Suppliers ,
Imports ,
International Trade ,
Registration Requirement ,
Regulatory Oversight ,
Regulatory Standards ,
Suppliers
On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more
10/20/2020
/ China ,
Generic Drugs ,
Hatch-Waxman ,
Innovation ,
Intellectual Property Protection ,
Life Sciences ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) proposed an...more
On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early...more
On 6 July, China’s National People’s Congress (NPC) published additional amendments to its draft patent law, which was first released in January 2019. As we reported at that time here, the proposed Chinese Patent Law...more
The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more
5/21/2019
/ Biopharmaceutical ,
Biotechnology ,
CGMP ,
China ,
Drug Pricing ,
Generic Drugs ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications -
On 28 March China's National Medical Products Administration (NMPA) published a list of an...more
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more
With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more
12/11/2018
/ China ,
Competitive Bidding ,
Drug Pricing ,
Generic Drugs ,
Healthcare ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Research and Development
Last Friday, China announced a second round of American products that could be subject to retaliatory tariffs between 10 to 25 percent. 1/ The proposed list would target $60 billion worth of additional United States...more
8/14/2018
/ China ,
Exports ,
Farms ,
Food Supply ,
Imports ,
Supply Chain ,
Tariffs ,
Trade Relations ,
Trade Retaliation ,
Trump Administration ,
US Trade Policies
On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good...more