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- CFDA Seeks to Remove Some Barriers to Foreign Drug Entry into China
CFDA Seeks to Remove Some Barriers to Foreign Drug Entry into China
April 7, 2017, Covington Alert
On March 17, 2017, the China Food and Drug Administration (“CFDA”) released a notice to seek public comments on four proposed adjustments to China’s drug registration requirements (“Proposed Adjustments”) that will remove some barriers to applications for clinical trials and drug registrations of imported drugs (drugs that are manufactured outside of China). The Proposed Adjustments could substantially impact the strategies for bringing imported drugs to China. Imported drug manufacturers should understand the potential impact of the Proposed Adjustments, consider submitting comments, and closely monitor future developments in this area. Comments are due on April 20, 2017.
May 19, 2017, Bloomberg Law
Shaoyu "Andrew" Chen is quoted in a Bloomberg Law article regarding the latest series of announcements from China's Food and Drug Administration on accelerating drug and medical device approvals. According to Chen, “The four documents proposed many critical policies that will bring China much closer to Western countries in the regulatory oversight of drugs and ...
January 23, 2017, Covington Alert
On January 9, 2017, eight Chinese ministries announced a significant new policy that aims to reduce marked-up prices and corruption in multi-tier distribution chains. The policy effectively requires that under most circumstances, at most two invoices may be issued throughout the distribution chain, with one from the manufacturer to a distributor and another from the distributor to the end hospital. The policy applies only to drugs, but some provinces reportedly have been implementing similar policies for medical devices.
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to unawareness of the regime and uncertainty over its requirements.