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Data protection in Canada: too much? Too little?
  • Gowling WLG
  • Canada
  • June 28 2011

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.


Two amendments to pharma legislation come into force
  • Gowling WLG
  • Canada
  • April 14 2011

The Amendments to The Food and Drug Regulations (1319- New Drugs For Extraordinary Use) came into force on March 25, 2011.


Board follows guidelines in Penlac decision
  • Gowling WLG
  • Canada
  • February 7 2011

On February 3, 2011, the Patented Medicine Prices Review Board (the Board) released its decision dated January 31, 2011, regarding Penlac, a drug manufactured by sanofi-aventis.


Generic manufacturers in Europe seek regulatory changes
  • Gowling WLG
  • European Union
  • February 12 2010

The European Generic Medicines Association (EGA) is advocating for changes to regulatory framework of the European Union with respect to the marketing of generics and biosimilars in the European Union.


Amendments to Ontario's Record of Site Condition Regulation O. Reg. 15304
  • Gowling WLG
  • Canada
  • January 6 2010

The long anticipated amendments to Ontario Regulation 15304 were quietly filed on December 29, 2009.


New disclosure requirements for clinical trials
  • Gowling WLG
  • Global
  • December 3 2009

The International Federation of Pharmaceutical Manufactures and Associations (IFPMA) has released its latest Joint Position which will require member companies to disclose information on all clinical trials in patients.


U.S. patients receive greater access to unapproved medications
  • Gowling WLG
  • USA
  • August 21 2009

Seriously ill patients will have greater and easier access to unapproved medicines due to new USFDA regulations.


FDA clinical trial regulations - "Sentinal System"
  • Gowling WLG
  • USA
  • May 29 2008

On Thursday May 22, 2008, U.S. health officials announced that the FDA will implement a proactive system designed to help identify dangers associated with prescription drugs and medical devices that are currently on the market.


Implemention of “Bolar” in the EU
  • Gowling WLG
  • United Kingdom, European Union
  • October 31 2007

In Europe, Directive 200427EC (amending Directive 200183EC) introduced into European Union legislation for the first time an exemption from patent infringement for conducting certain developmental work pre-patent expiry (the EU ‘Bolar’ exemption).


Harry Dahme
  • Gowling WLG