Bioequivalence and Bioavailability Forum

Irukulla Shravan Kumar ★ India, 2013-05-28 08:00 (4364 d 09:23 ago) Posting: # 10669 Views: 18,856	Differences [Tips / Tricks] Post reply
	dear, what is the difference between regulation, guideline, Law and act Regards, I.Shravan

Helmut
★★★

Vienna, Austria,
2013-05-28 16:22
(4364 d 01:01 ago)

@ Irukulla Shravan Kumar
Posting: # 10675
Views: 15,840

Hard and soft law

Post reply

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

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

guideline

an indication or outline of policy or conduct

law (leaving laws of nature like Einstein’s E = mc² and Pocock’s α_adj = 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
a rule of construction or procedure
the whole body of laws relating to one subject

act

the formal product of a legislative body: statute; also: a decision or determination of a sovereign, a legislative council, or a court of justice

directive

something that serves to direct, guide, and usually impel toward an action or goal; especially: an authoritative instrument issued by a high-level body or official

Confused? 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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Helmut Schütz

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ElMaestro
★★★

Denmark,
2013-05-28 16:37
(4364 d 00:46 ago)

@ Irukulla Shravan Kumar
Posting: # 10676
Views: 15,686

Differences

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Hi Irukulla,

I agree with Helmut.
Also, I have been told recently that one should distinguish between guidances and guidelines when it comes to FDA. If I got it right, guidelines are law whereas guidance is not although both may be marked with the usual 'contains nonbinding recommendations' or words to that effect.

I tried to search the CFRs and on FDA's homepage if I could find backup for it, but I got nothing so far. It may very well be because I -sailor, simulant but not lawyer- don't know where to look.

—
Pass or fail!
ElMaestro

Helmut
★★★

Vienna, Austria,
2013-05-28 16:56
(4364 d 00:27 ago)

@ ElMaestro
Posting: # 10677
Views: 15,748

John, are you there?

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Hi ElMaestro!

❝ Also, I have been told recently that one should distinguish between guidances and guidelines when it comes to FDA. If I got it right, guidelines are law whereas guidance is not although both may be marked with the usual 'contains nonbinding recommendations' or words to that effect.

Interesting. I never came across the term ‘guideline’ with the FDA. Maybe John knows something about it? Barbara Davit mentioned in the BABE-conference in Ljubljana 2010 that according to a verdict of the US High Court FDA’s draft guidances¹ are as binding as the final ones.² :rotfl:

When EMA’s IR guideline was presented Tomas Salmonson explained why they had to change the title from ‘Note for Guidance…’ to ‘Guideline…’. Since when it comes to legal stuff my brain switches off immediately I can’t report the reason.

Contains Nonbinding Recommendations
This draft guidance, once finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic.* It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs.
Contains Nonbinding Recommendations
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs.

So it ‘will represent’ FDA’s current thinking ‘once finalized’.
Who’s thinking does a guidance represent now?

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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jag009
★★★

NJ,
2013-05-28 23:12
(4363 d 18:10 ago)

@ Helmut
Posting: # 10678
Views: 15,617

John, are you there?

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Hi Helmut!

We in US had Monday as a holiday you know. Yeah it's Tuesday and I am still on holiday mood... :party:

I "think" guidance is not cast in stone and you can present alternatives to FDA as long as you can justify them, even if it's the finalized guidance.

Guideline is cast in stone.

There are guidelines on FDA website. Example, Drug Master File Guideline

Regarding draft BA/BE guidances... Pretty much all the people I know treat the draft as final. In fact if you look at FDA's BE recommendations for specific drug products (The document which indicate the types of BE studies to be conducted), I think majority of them (I looked at some as far back as 2008) are still in draft.

Thanks
John

Helmut
★★★

Vienna, Austria,
2013-05-29 01:27
(4363 d 15:56 ago)

@ jag009
Posting: # 10679
Views: 15,787

Guideline # guidance

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Hi John,

❝ Guideline is cast in stone.

I see. As a cave diver I’m familiar with guidelines. No discussion about their necessity.

❝ […] Drug Master File Guideline

“IV.D.4. […] The submitter should punch holes 8 1/2 inches apart in each page.”

Makes sense.

If I understand this list correctly this guideline [sic] is still in force:

“The data analyses should include appropriate statistical analyses involving Analysis of Variance, calculations of power analysis, 95% confidence intervals, and ratio analysis (75/75–125 Rule).”

What the heck?

❝ Regarding draft BA/BE guidances... […] I think majority of them (I looked at some as far back as 2008) are still in draft.

2008? That’s nothing. Have a look at this goody’s date.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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jag009
★★★

NJ,
2013-05-30 18:08
(4361 d 23:15 ago)

@ Helmut
Posting: # 10686
Views: 15,428

Guideline # guidance

Post reply

Hi Helmut,

❝ ❝ Regarding draft BA/BE guidances... […] I think majority of them (I looked at some as far back as 2008) are still in draft.

❝

❝ 2008? That’s nothing. Have a look at this goody’s date.

I always wonder why some guidances are final and yet some (if not many) are still in draft form after so many years (yes I mean ones that are older than 2008). I just don't know what the definition of "final" is in FDA's book. Maybe they just just too lazy to update the guidances???

John

Helmut
★★★

Vienna, Austria,
2013-05-30 19:59
(4361 d 21:24 ago)

@ jag009
Posting: # 10687
Views: 15,447

As time passes by

Post reply

Hi John,

❝ […] I just don't know what the definition of "final" is in FDA's book. Maybe they just just too lazy to update the guidances???

God moves in mysterious ways.

What do I care about my chitchat from yesterday?
Nothing prevents me to become wiser. Konrad Adenauer

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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jag009 ★★★ NJ, 2013-05-31 17:15 (4361 d 00:08 ago) @ Helmut Posting: # 10702 Views: 15,395	As time passes by Post reply
	Hi Helmut, You mean lazy? John

Differences [Tips / Tricks]

Hard and soft law

Differences

John, are you there?

John, are you there?

Guideline # guidance

Guideline # guidance

As time passes by

As time passes by