EMEA GUIDANCES

CPMP/EWP/4151/00 Rev. 1 Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) http://www.emea.europa.eu/pdfs/human/ewp/415100enrev1.pdf 

Pharmaceutical Quality of Inhalation and Nasal Products (EMEA/CHMP/QWP/49313/2005 )http://www.emea.europa.eu/pdfs/human/qwp/4931305en.pdf

Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products, CPMP/QWP/2845/00 http://www.emea.europa.eu/pdfs/human/qwp/284500en.pdf

Note for Guidance on Dry Powder Inhalers CPMP/QWP/158/96 http://www.emea.europa.eu/pdfs/human/qwp/015896en.pdf    

Pharmaceutical Quality of Inhalation and Nasal Products.  http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/inhalationnas_e.pdf

Submission Requirements for Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma http://hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-gpsa/pdf/prodpharma/inhal_corticost_e.pdf   or http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/nas_rhin_e.html

Submission Requirements for Subsequent Market Entry Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis  http://hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/nas_rhin_e.pdf

MDI/DPI CMC Draft Guidance

Nasal Spray/Inhalation Solution, Suspension, and Spray CMC Final Guidance

2003 Draft BA/BE of Nasal Aerosols/Nasal Sprays Draft Guidance

Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999

Inhalation Drug Products Packaged in Semipermeable Container Closure Systems Draft Guidance