A structured guide to product regulation and liability laws in China
A structured guide to clinical trials in China
On July 25, 2016, the China Food and Drug Administration ("CFDA") published the Administrative Provisions for Drug Registration (Revision) (the
FDA issued a draft guidance on March 18, 2014 titled, "Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations
On October 17, Canadian Prime Minister Stephen Harper flew to Brussels to conclude a Comprehensive Economic and Trade Agreement ("CETA"), or free
On August 27, 2013, the Ministry of Food and Drug Safety ("MFDS") issued a previous announcement of legislation to amend the Pharmaceutical Affairs
On September 6, 2013, the China Food and Drug Administration (CFDA) announced that it has established a Registration and Information Disclosure
‘Pay-for-delay’ agreements between innovator and generic manufacturers have been the subject of much controversy.
Prior to the enactment in 2006 of the amendments to section C.08.004.1 of the Food and Drugs Regulations (Data Protection Regulations), Canada did not have an effective regime of data protection exclusivity.
The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics).