Hard and soft law [Tips / Tricks]

posted by Helmut Homepage – Vienna, Austria, 2013-05-28 16:22 (3957 d 11:13 ago) – Posting: # 10675
Views: 14,295

Hi Irukulla!

❝ what is the difference between regulation, guideline, Law and act


Very good question! Maybe it’s telling that FDA’s Barbara Davit is not only a Ph.D. but also a J.D. ;-)

You forgot the European term directive

According to Merriam-Webster:

regulation
  1. the act of regulating: the state of being regulated
    1. an authoritative rule dealing with details or procedure
    2. a rule or order issued by an executive authority or regulatory agency of a government and having the force of law
guidelinelaw (leaving laws of nature like Einstein’s E = mc2 and Pocock’s αadj = 0.0294 aside)
    1. (1) a binding custom or practice of a community: a rule of conduct or action prescribed or formally recognized as binding or enforced by a controlling authority
      (2) the whole body of such customs, practices, or rules
    2. (1) the control brought about by the existence or enforcement of such law
      (2) the action of laws considered as a means of redressing wrongs; also: litigation
      (3) the agency of or an agent of established law
    3. a rule or order that it is advisable or obligatory to observe
    4. something compatible with or enforceable by established law
  1. a rule of construction or procedure
  2. the whole body of laws relating to one subject
actdirectiveConfused? Ask a regulator/lawyer. :-D

Simply speaking laws/acts often require us to work according to guidelines (sometimes called “soft law”). Guidelines represent state of the art knowledge at the time of publication and allow deviating from them if scientifically justified. A special case is the EU – one example: Directive 2001/20/EC (Implementation of GCP in the Conduct of Clinical Trials on Medicinal Products for Human Use) was incorporated in the Medicines Acts of all member states and therefore became a law… Regularly assessors of Jordan’s FDA ask for a “GCP Certificate” which does not – and will never – exist. If a study in the EU would not have been performed in compliance with GCP this would have been simply illegal.
Salomon Stavchansky once told me that a wrong definition of bioavailability was stated in Brazil. The problem was that it was not only given in the guideline (ANVISA: Resolução) – which could have been corrected rather quickly – but also in the law (Legislação). It took Brazil two years to correct it. That’s democracy.

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