IPAC-RS COMMENTS
CHINESE AGENCIES AND ORGANIZATIONS
IPAC-RS Comments to CDE Liquids for Nebulization Draft Guideline
English version
July 30, 2021
IPAC-RS Comments to CDE OIDP Equivalence Draft Guideline
IPAC-RS Comments to CDE
August 30, 2019
IPAC-RS Comments to CNPPA guideline on extraction studies for inhalation products.
April 22, 2019
IPAC-RS Comments to Chinese Pharmacopoeial chapters on OINDP.
April 22, 2019
BRAZIL
IPAC-RS Comments to Anvisa draft OINDP bioequivalence guideline
June 7, 2018
IPAC-RS Comments to Anvisa draft OINDP bioequivalence normative instruction
June 7, 2018
EMA
Guideline on the quality requirements for drug-device combinations
August 23, 2019
Docket #: CHMP/QWP/BWP/259165/2019
Orally Inhaled Product Bioequivalence Clinical Documentation Concept Paper
June 30, 2017
Docket #: EMA/CHMP/267194/2016
OINDP Quality Guideline Concept Paper
June 30, 2017
Docket #: EMA/CHMP/QWP/11577/2017
Drug-Device Combination Concept Paper
May 12, 2017
Docket #: EMA/CHMP/QWP/BWP/661488/2016
Revision of Points To Consider on the Requirements for Clinical Documentation for OIP
May 23, 2007
Docket #: CPMP/EWP/4151/00
Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products
May 18, 2001
Docket #: CPMP/QWP/2845/00
HEALTH CANADA
July 17, 2023
IPAC-RS Comments Health Canada PK Guidance 2020
June 23, 2020
IPAC-RS Comments on the Health Canada Draft Guideline for Nasal Products
August 02, 2007
Comments on the Health Canada Guideline for Corticosteroid Products
August 02, 2007
ISO AND ICH
IPAC-RS Comments on ICH Q2(R2) (July 2022)
IPAC-RS Comments on ICH Q14 (July 2022)
Joint paper by IPAC-RS and EPAG regarding draft ISO standard for aerosol drug delivery devices
November 07, 2008
Comments on the Uniformity of Dosage Units proposal by ICH/Pharmacopeial Discussion Group
April 25, 2001
THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
Post Transition Regulations in the UK
October 23, 2020
The Application of Analytical Quality by Design Concepts to Pharmacopoeial Standards for Medicines
August 28, 2019
Docket #: AQbD 2019
Human Factors and Usability Engineering
August 04, 2016
US FOOD AND DRUG ADMINISTRATION (FDA)
February 2, 2023
Docket#: FDA-2001-D-0197
IPAC-RS Comments on ICH Q12: Implementation Considerations for FDA-Regulated Products
July 19, 2021
Docket #: FDA-2021-D-0166
IPAC-RS Comments on FDA EUA Draft Guidance 2020
June 22, 2020
Docket #: FDA-2019-D-5573
IPAC-RS Response to FDA Comments on USP Stimuli Article AIM EDA
September 09, 2019
Docket #: REF: 09-18-022-J
IPAC-RS Comments on FDA Draft IFU Guidance
August 28, 2019
Docket #: FDA-2019-D-1615
Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff
May 07, 2019
Docket #: FDA-2010-D-0078
May 7, 2019
Docket # FDA-2019-D-0078-0006
IPAC-RS Comments on FDA HF Guidance
November 29, 2018
Docket #: FDA-2018-D-3275
Comments to the docket on DRAFT MDI / DPI Guidance
June 20, 2018
Docket #: FDA-2018-D-1098
Draft Guidance on Comparative Analyses and Related Comparative Use Human Factors Studies
March 16, 2017
Docket #: FDA-2016-D-4412
IPAC-RS Comments to the USFDA prior to 2017 are available here.
USP
IPAC-RS Comments on USP <429> “Particle Size Analysis by Laser Light Diffraction” [PF 49(5)] (November 1, 2023)
IPAC-RS Comments on Pharmacopoeial Forum 49(2) Chapter <1031> "The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants" (May 2023)
IPAC-RS Comments on Pharmacopoeial Forum 49(2) Chapter <87> Biological Reactivity Tests, In Vitro and Chapter <88> Biological Reactivity Tests, In Vivo (May 2023)
IPAC-RS Comments on USP Revised Chapter <604> “Leak Rate (of aerosol containers)” (January 2023)
IPAC-RS Comments on the USP Stimulus Article Testing the In Vitro Product Performance of Inhalation and Nasal Drug Products: Views of the USP Expert Panel [PharmForum 48(5) September 2022] (November 29, 2022)
IPAC-RS Comments on USP <601> “Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests” PF48(4) (September 13, 2022)
IPAC-RS Comments on USP <1604> Presentation of Aerodynamic Particle Size Distribution (APSD) Measurement Data for Orally Inhaled Drug Products PF48(1) (March 31, 2022)
IPAC-RS Comments on Pharmacopoeial Forum Chapter <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants (September 30, 2021)
IPAC-RS Comments on Pharmacopoeial Forum Chapter <88> Biological Reactivity Tests, In Vivo (September 30, 2021)
IPAC-RS Comments on Pharmacopoeial Forum Chapter 〈87〉 Biological Reactivity Tests, In Vitro (September 30, 2021)
November 19, 2020
IPAC-RS Comments on USP <1220> Analytical Procedure Life Cycle
October 28, 2020
September 28, 2020
August 17, 2020
IPAC-RS Comments on Elastomeric Components for Inhalation Packaging/Delivery Systems Jan 2020
IPAC-RS Comments on USP Stimulus Article
July 31, 2017
Docket #: Pharm.Forum 43(3) 2017]
Comments on “Proposed Revisions to the General Notices and Requirements” in Pharm.Forum 41(1)
March 17, 2015
Comments on USP 1661 Evaluation of Plastic Packaging Systems and Their Materials of Construction
January 29, 2015
Comments on USP chapters 661, 661.1, and 661.2
December 01, 2014
Comments on “USP Statistical Tools for Procedure Validation”
November 26, 2014