emea目录

emea目录

Scientific Guidelines for Human Medicinal Products

Quality Guidelines

#NAME?

Reference

Title

Number

Publicatio

Effective

nDate

Date

OtherRemarks

Active substance

Active Substance Master File Procedure

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CPMP/QWP/227/02 Rev. 2

Release forconsultation Apr 2006

Deadlinefor

comments Aug2006

Feb 2005Aug 2004Feb 2004Apr 1994Oct 1987

Summary of Requirements for Active

Substances in the Quality Part of the DossierActive Substance Master File ProcedureChemistry of New Active SubstancesInvestigation of Chiral Active SubstancesChemistry of Active Substances

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CHMP/QWP/297/97 Rev. 1

CPMP/QWP/227/02 Rev. 1

CPMP/QWP/130/96 Rev. 13CC29A3AQ5A

CPMP/QWP/848/96

CPMP/QWP/2054/03

CPMP/QWP/159/01

CPMP/QWP/486/95

CPMP/QWP/072/963AQ4A

Jun 2004Apr 2005Dec 2003Oct 1993

Manufacture of the medicinal product

Process Validation

Annex II: Process Validation - Non-StandardProcesses

Limitations to the Use of Ethylene Oxide in theManufacture of Medicinal Products

Manufacture of the Finished Dosage FormAnnex: Start of Shelf-Life of the FinishedDosage Form

The use of Ionizing Radiation in theManufacture of Medicinal Products

Feb 2001Jul 2004Mar 2001Sep 1995May 2001Dec 1991

Sep 2001Jan 2005Apr 2001Apr 1996Dec 2001Jul 1992

Impurities

Limits of genotoxic impurities

CPMP/SWP/5199/02

EMEA/CHMP/QWP/251344/2006

CPMP/QWP/1529/04CPMP/ICH/2738/99-ICHQ3B (R2)CPMP/ICH/2737/99-ICHQ3A (R2)CPMP/ICH/283/95-ICHQ3C (R3)

CPMP/QWP/450/03

Jun 2006

Jan 2007

Q&Ashere

Control of Impurities of PharmacopoeialSubstances

Impurities in New Medicinal Products (ICHQ3B)

Impurities Testing: Impurities in New DrugSubstances (ICH Q3A)

Impurities: Residual Solvents (ICH Q3C)

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Dec 2003Feb 2003

Apr 2004Aug 2003

Feb 2002Aug 2002

Sep 1997Mar 1998

Annexes to Specifications for class 1 and class2 residual solvents in active substances

Jul 2004Jan 2005

Specifications, analytical procedures and analytical validationSetting Specifications for Related Impurities inuCHMP/CVMP/QRelease for

Antibiotics

WP/136351/08

consultatio

n Jun 2008

Deadlinefor

comments Oct2008

Jun 2008

Evaluation and Recommendation of

Pharmacopoeial Texts for Use in the ICHRegions (ICH Q4B)

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CHMP/ICH/222007/06

Dec 2007

emea目录

Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (ICH Q4B) Annex 1 to Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (ICH Q4B) on Residue on Ignition/Sulphated Ash General Chapter Annex 2 to Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (ICH Q4B) on Test for Extractable Volume in Parenteral Preparations General Chapter Annex 3 to Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (ICH Q4B) on Test for Particulate Contamination: Sub-Visible Particles General Chapter Annex 4A to Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micrologic

al examination of nonsterile products: micrological enumeration tests Annex 4B to Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for micrological examination of non-sterile products: tests for specified microorganisms Annex 4C to Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for micrological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use Annex 5 to Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test general chapter

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uICH Q4B

Dec 2007

Jun 2008

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CHMP/ICH/222 063/06 ICH Q4B

Dec 2007

Jun 2008

u

u

CHMP/ICH/559 409/2007 ICH Q4B

Jun 2008

Dec 2008

u

u

CHMP/ICH/561 176/2007 ICH Q4B

Jun 2008

Dec 2008

u

CHMP/ICH/308 671/07

Release for consultatio n Jun 2008

u

CHMP/ICH/308 817/07

Release for consultatio n Jun 2008

u

CHMP/ICH/308 867/08

Release for consultatio n Jun 2008

Deadline for commen ts Sep 2008 Deadline for commen ts Sep 2008 Deadline for commen ts Sep 2008 Deadline for commen ts Sep 2008 Deadline for commen ts 31 Aug 2009 Aug 2003

u

CHMP/ICH/308 895/08

Release for consultatio n Jun 2008

Use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations revision 1

u

u

EMEA/CHMP/CV Feb 2009 MP/QWP/17760 /2009 Rev 1

Use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Parametric Release

u

CPMP/QWP/ 3309/01

Feb 2003

u

CHMP/QWP/569 December 959/2008 2008

Deadline for commen ts: February 2009 Sep 2001 May 2000

Parametric Release Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (ICH Q6A)

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CPMP/QWP/301 Feb 2001 5/99 CPMP/ICH/ Nov 1999 367/96-ICH Q6A

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emea目录

Validation of Analytical Procedures: Text andMethodology (ICH Q2)

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CPMP/ICH/381/Nov 199495 - ICH Q2(Part I),(R1)Dec 1996

(Part II)

Specifications and control Tests on theFinished Product

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3AQ11ADec 1991

Jun 1995Combine(Part I), Juns former1997 (Part II)ICH Q2A

(Definitions andTerminology) andICH Q2B(Methodology)guidelines

Jun 1992

Excipients

Excipients in the Dossier for Application forMarketing Authorisation of a Medicinal ProductExcipients in the Dossier for Application forMarketing Authorisation of a Medicinal Product

CHMP/QWP/396Jul 2007Jan 2008951/06

CHMP/QWP/419Release for/03consultatio

n Feb 2003

Superseded byNov2006version

Excipients in the label and package leaflet ofmedicinal products for human use

Quality of Water for Pharmaceutical UseReflection Paper on Water for Injectionprepared by Reverse Osmosis

Inclusion of Antioxidants and AntimicrobialPreservatives in Medicinal Products

Excipients in the Dossier for Application forMarketing Authorisation of a Medicinal Product

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CPMP/QWP/158/01 Rev. 1CHMP/CVMP/28271/08

CPMP/CVMP/QWP /115/953AQ9A

Jul 2003May 2002Mar 2008Jul 1997Feb 1994

Jul 2003Jun 2002

Jan 1998

Underrevision

Dec 2005

Packaging

Plastic Primary Packaging Materials

CPMP/QWP/435May 20059/03

CPMP/QWP/576May 2005/96 Rev 1CPMP/ICH/Feb 20032736/99-ICHQ1A (R2)CPMP/QWP/Dec 2003122/02 Rev. 1corr

Stability

Stability Testing for Applications for Variationsto a Marketing Authorisation

Stability Testing of New Drug Substances andDrug Products (ICH Q1A).

Stability Testing of Existing Active Ingredientsand Related Finished Products.

Dec 2005Aug 2003

Mar 2004

March2007minorcorrection torevision1. Thewordingin

paragraph 2.1.1wasrevisedto clarifythe needfor

testingunderaccelerated orintermediatestorageconditions.

emea目录

Annex: Declaration of Storage Conditions forMedicinal Products Particulars and ActiveSubstances

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CPMP/QWP/609/96 Rev. 2

Apr 2003Oct 2003

Evaluation of Stability Data (ICH Q1E)

uuuStability Data Package for Registration inClimatic Zones III and IV (ICH Q1F)

Bracketing and Matrixing Designs for StabilityTesting of Drug Substances and Drug Products(ICH Q1D)

In-Use Stability Testing of Human MedicinalProducts

Maximum Shelf-Life for Sterile Products forHuman Use after first opening or followingReconstitution

Photostability Testing of New Active

Substances and Medicinal Products (ICH Q1B)Stability Testing: Requirements for NewDosage Forms (ICH Q1C)

CPMP/ICH/420/02-ICHQ1E

CPMP/ICH/421/02-ICHQ1F

CPMP/ICH/4104/00-ICHQ1D

CPMP/QWP/2934/99

CPMP/QWP/159/96 Corr.

Feb 2003Aug 2003

September 2007minorrevisionto

improvethe

clarity ofthe text.

Feb 2003Aug 2003

Feb 2002Aug 2002

Feb 2001Jan 1998

Sep 2001Jul 1998

CPMP/ICH/279/Dec 199695-ICH Q1BCPMP/ICH/Dec 1996280/95-ICHQ1C

EMEA/138931/0Release for8consultatio

n July2008

Jan 1998Jan 1998

Pharmaceutical development

Pharmaceutical Development of Medicines forPaediatric Use

u

Deadlinefor

comments 30November 2008

May 2006

Pharmaceutical Development (ICH Q8)

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Annex to Pharmaceutical Development (ICHQ8)

Investigation of Bioavailability andBioequivalence

EMEA/CHMP/167068 /2004-ICHQ8

EMEA/CHMP/ICH/518819/2007CPMP/EWP/QWP/140/98 Rev.1

Nov 2005

Dec 2008Release forconsultation July2008

Jun 2009

Deadlinefor

comments 31January2009

Jan 2002Aug 1999

Investigation of Bioavailability andBioequivalence

Annex to Development Pharmaceutics:Decision trees for selection of sterilisationmethods

Development Pharmaceutics

u

CPMP/EWP/QWJul 2001P/1401/98CPMP/QWP/Feb 1999054/98

CPMP/QWP/155Jan 1998/96

Jul 1998

Specific types of products

emea目录

Medicinal Gases: Pharmaceutical Documentation (including recommendation on non-clinical safety requirements for well established medicinal gases)

u

u

CPMP/QWP/171 Jan 2002 9/00 (addition of annex 1 in June 2008)

Aug 2002 (annex 1 from October 2008)

Specifi

cation Limits for Residues of Metal Catalysts

uu

u

CPMP/SWP/QW Feb 2008 P/4446/00

Sep 2008

Annex 1 (Recom mendati on on safety requirem ents) was added with revision 1 of the guideline publishe d in 2008. No other changes were introduc ed with revision 1

Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials Pharmaceutical Quality of Inhalation and Nasal Products Radiopharmaceuticals

u

CHMP/QWP/185 Mar 2006 401/2004

Oct 2006

u u u u u u

Radiopharmaceuticals

CHMP/QWP/493 13/2005 CHMP/QWP/306 970/2007 Rev. 1 3AQ20A

Apr 2006

Oct 2006

November May 2009 2008 Dec 1990 Jun 1991 Superse ded by CHMP/Q WP/3069 70/2007

Suitability of the Graduation of Delivery Devices for Liquid Dosage Forms

u

CHMP/QWP/178 Feb 2005 621/05

Guidel ine replac ed by the Questi on and Answer publis hed on the EMEA websit e hereJan 2000

Development of CHMP Guideline on Dosing Delivery of Injectable Liquids Quality of Modified Release Products A) Oral Solid Dosage Forms B) Transdermal Dosage Forms Section I (Quality) Radiopharmaceuticals Based on Monoclonal Antibodies

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CHMP/QWP/188 Jun 2004 8/04 CPMP/QWP/ Jul 1999 604/96 3AQ21A May 1991

Jan 1992

Herbal Medicinal Products

emea目录

Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products

u

EMEA/HMPC/36 Release for 26/09 consultatio n Jan 2009

Deadline for consultat ion 15 May 2009

List of questions & answers (Q&A) received during the HMPC assessors training on quality issues emerging for herbal medicinal products (held on 7 December 2007, EMEA) Reflection paper on level of purification of extracts to be considered as herbal preparations

u

EMEA/531300/0 Jan 2009 8

u

u

EMEA/HMPC/18 Release for 6645/08 comments Nov 2008

Development of a guideline on preparation on herbal teas

u

EMEA/HMCP/45 Release for 1978/08 consultatio n Sep 2008

Deadline for commen ts 15 Apr 2009 Deadline for commen ts 15 Jan 2009

Markers used for quantitative and qualitative analysis of Herbal Medicinal Products and traditional Herbal Medicinal Products Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products The use of Fumigants Good Agricultural and Collection Practice for starting materials of Herbal Origin Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products Test procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products / Traditional Herbal Medicinal Products

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EMEA/HMPC/25 Jul 2008 3629/07 EMEA/HMPC/CH Release for MP/CVMP/2875 consultatio 39/05 Rev. 1 n Oct 2008 Deadline for commen ts 30 Apr 2009 Nov 2008

u

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EMEA/HMPC/CH MP/CVMP/2148 69/06 EMEA/HMPC/12 5562/06 EMEA/HMPC/24 6816/05 CPMP/QWP/281 9/00 Rev. 1 CPMP/QWP/282 0/00

Rev. 1

Jun 2008

Oct 2006 Jul 2005 Mar 2006 Mar 2006 Aug 2006 Oct 2006 Oct 2006

Reference Title Number

Publicatio Effective n Date Date

Other Remarks

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