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Regulation booklets: Updating policy and current revisions

Updating policy

Principles

As some updates (primarily FDA) can be changed or withdrawn with short notice before they are coming into operation, we never update regulatory texts or guides before the actual date they are in operation.

Smaller updates that are not affecting the actual regulatory meaning (as changed addresses or similar information), or do not apply to the pharmaceutical or medical device field, do not give rise to an immediate revision of a booklet. This kind of information will be updated in the next print.
Information about not yet included updates can be found below.*

Revision dates and update sources

US FDA and the European Commission handles updates differently.

US FDA

The U.S. Authorities continously updates Title 21 for Food and Drugs of the "CFR, Code of Federal Regulations" and publish the updates/changes in the “Federal Register/ (FR)”. The current version of the regulation is then published by the U.S. Government Publishing Office (GPO) at the e-CFR site http://www.ecfr.gov

The FR publishing dates, volumes and pages are stated in the end of each updated paragraph in the booklets.
eg. [43 FR 45076, Sept, 29, 1978, as amended at 73 FR 40463, July 15, 2008, 74 FR 65431, Dec 12 2011]

EU GMP Guide 

The European Commission normally makes a revision by Guideline chapter.
The final version is published at the Eudralex web site 6 months before coming into operation.

The revision date for each chapter stated in the booklets is when it was coming into operation.

Current revisions

GMP Booklets in English

• 21 CFR Part 210 (Dec. 12, 2011)
• 21 CFR Part 211 (Mar. 20, 2013)*
• 21 CFR Part 11 (Jun. 19, 2015)*
• 21 CFR Part 820 (May. 23, 2016)
• 21 CFR Part 4 (Jul. 22, 2013)
• EU GMP guideline, Part I:
    - Chapter 1 Jan. 31, 2013
    - Chapter 2 Feb. 16, 2014
    - Chapter 3 Mar. 1, 2015
    - Chapter 4 Jun. 30, 2011
    - Chapter 5 Mar. 1, 2015
    - Chapter 6 Oct. 1, 2014
    - Chapter 7 Jan. 31, 2013
    - Chapter 8 Mar. 1, 2015
    - Chapter 9 Not stated
• EU GMP guideline, Part II (Sep. 24, 2014)
• EU GMP, Annexes:
    - Annex 1 Mar. 1, 2009
    - Annex 2 Jan. 31, 2013
    - Annex 8 Not stated
    - Annex 11 Jun. 30, 2011
    - Annex 13 Jul. 31, 2010
    - Annex 15 Oct. 1, 2015
    - Annex 16 Jan. 2002
    - Annex 17 Jan. 2002
    - Annex 19 Jun. 1, 2006
    - Glossary Not stated
• EU GDP guideline 2013/C 343/01 (Nov. 5, 2013)
• EU guidelines for excipients 2015/C 95/02 (Mar. 19, 2015)
• ISO 9001:2015 (Oct. 14, 2015)
• ISO 13485:2016 (Mar. 01, 2016)
• ICH Q8 (R2) (Aug 2009)
• ICH Q9 (Nov 2005)
• ICH Q10 (Jun 2008)
• ICH Q11 (May 2012)

  Français

• 21 CFR Partie 210 (12 dec 2011)
• 21 CFR Partie 211 (20 mar 2013)*
• 21 CFR Partie 820 (23 mai, 2016)
• EU GMP guide, Partie I, Ch. 1-9 (1 mar 2015, consultez anglais)
• EU GMP guide, Partie II (1 sep 2014)

   Svenska

• 21 CFR Part 210 (12 dec 2011)
• 21 CFR Part 211 (20 mar 2013)*
• 21 CFR Part 11 (19 juni 2015)*
• 21 CFR Part 820 (23 maj, 2016)
• EU GMP guide Part I (1 mar 2015, se engelska)
• EU GMP guide, Part II (24 sep 2014)
• EU GMP guide, Part III Hjälpämnen (19 mar 2015)
• EU GDP guide 2013/C 343/01 (5 nov 2013)
• LVFS 2014:8 (15 aug 2014)

   Dansk

• 21 CFR Part 210 (15 dec 2011)
• 21 CFR Part 211 (20 mar 2013)*
• 21 CFR Part 11 (19 juni 2015)*
• 21 CFR Part 820 (23 maj, 2016)
• EU GMP guide, Part I (1 mar 2015, se engelsk)
• EU GMP guide, Part II (24 sep 2014)

 

* New Updates in 21 CFR 11 and 211

21 CFR 11.1 Scope - Apr. 6, 2016, May 27, 2016
A number of exeptions regarding the food industry have been added.

21 CFR 211.94 Drug product containers and closures - Nov. 18, 2016
Requirements regarding Medical gas containers/closures and their labels and couloring have been added.

21 CFR 211.125 Labeling issuance - Nov. 18, 2016
Requirements regarding labeling reconciliation for portable cryogenic medical gas containers.

21 CFR 211.176 Penicillin contamination - July 29, 2016
Changed address to FDA (CDER Division of Research and Testing)

Theese changes will be updated at the next print occation for each publication.
Please contact us if you wish an insert with the above updates.