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Ropes & Gray LLP | China, Global | 7 Jan 2019

Life Sciences: product regulation and liability in China

A structured guide to product regulation and liability laws in China


Ropes & Gray LLP | China, Global | 7 Jan 2019

Clinical trials in China

A structured guide to clinical trials in China


King & Wood Mallesons | China | 1 Aug 2016

Highlights on the draft rules of drug registration

On July 25, 2016, the China Food and Drug Administration ("CFDA") published the Administrative Provisions for Drug Registration (Revision) (the


Haug Partners LLP | USA | 25 Mar 2014

Bioavailability and Bioequivalence draft guidance for NDAs and INDs issued by FDA

FDA issued a draft guidance on March 18, 2014 titled, "Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations


DLA Piper | Canada, European Union | 31 Oct 2013

Canada-Europe Free Trade Agreement: a new prescription for drug patents in Canada

On October 17, Canadian Prime Minister Stephen Harper flew to Brussels to conclude a Comprehensive Economic and Trade Agreement ("CETA"), or free


Yoon & Yang LLC | South Korea | 8 Oct 2013

Previous announcement of legislation to amend the Pharmaceutical Affairs Act

On August 27, 2013, the Ministry of Food and Drug Safety ("MFDS") issued a previous announcement of legislation to amend the Pharmaceutical Affairs


Sidley Austin LLP | China | 26 Sep 2013

China CFDA launches a Registration Platform for Drug Clinical Studies

On September 6, 2013, the China Food and Drug Administration (CFDA) announced that it has established a Registration and Information Disclosure


Venable LLP | USA | 13 Jun 2012

The legality of reverse payment settlements in paragraphy IV settle disputes

‘Pay-for-delay’ agreements between innovator and generic manufacturers have been the subject of much controversy.


Gowling WLG | Canada | 28 Jun 2011

Data protection in Canada: too much? Too little?

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.


Shook Hardy & Bacon LLP | USA | 18 Nov 2010

Stakeholders provide input on FDA review standards for biosimilars

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).

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