Regulatory Comments

ISPE comments on proposed regulations and guidance that affect the bio/pharmaceutical industry. Comments are solicited from ISPE Communities of Practice (COPs), Committees, Councils, Task Teams, and Members-at-large. Below is a list of items on which the Society has submitted comments. Click the titles to view the comments.

• 2024

  Aug 2024	FDA	Draft Guidance: Platform Technology Designation Program for Drug Development
  Aug 2024	IMDRF	Good machine learning practice for medical device development - Guiding Principles
  Aug 2024	EMA	Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures
  Mar 2024	EMA	Preliminary QIG Considerations regarding Pharmaceutical Process Models
  Mar 2024	FDA	Draft Guidance: Potency Assurance for Cellular and Gene Therapy Products
  Feb 2024	FDA	Draft Guidance: Advanced Manufacturing Technologies Designation Program

• 2023

  Dec 2023	EMA	Reflection Paper on the Use of Artificial Intelligence in the Lifecycle of Medicines
  Dec 2023	FDA	Quality Management Maturity Program for Drug Manufacturing Establishments
  Nov 2023	European Commission	Proposal for a REGULATION of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use…
  Nov 2023	European Commission	Proposal for a DIRECTIVE of the European Parliament and of the Council on the Union code relating to medicinal products for human use
  Sept 2023	European Commission	Call for Evidence: Pharmaceuticals—for changes to marketing authorisations (Revision of the variation framework for medicines)
  Sept 2023	FDA	Draft Guidance: Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
  Aug 2023	FDA	ICH E6(R3) Guideline for Good Clinical Practice
  Aug 2023	FDA	Draft Guidance: Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Elements and Terminologies.
  Aug 2023	FDA	Discussion Paper: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products.
  May 2023	FDA	Draft Guidance:  Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers
  May 2023	FDA	Discussion Paper: Artificial Intelligence in Drug Manufacturing
  Mar 2023	FDA	Draft Guidance: Content of Human Factors Information in Medical Device Marketing Submissions
  Jan 2023	EMA	Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems

• 2022

  Dec 2022	FDA	Distributed Manufacturing and Point-of-Care Manufacturing of Drugs Discussion Paper
  Nov 2022	FDA	Computer Software Assurance for Production and Quality System Software
  Aug 2022	FDA	Risk Management Plans to Mitigate the Potential for Drug Shortages
  Aug 2022	WHO	Global Model Regulatory Framework for medical devices including IVDs (GMRF)
  Jul 2022	ICH	ICH Q2 (R2): Validation of Analytical Procedures
  Jul 2022	ICH	ICH Q14: Analytical Procedure Development
  Jul 2022	OECD	OECD draft Advisory Document No. 17. Supplement No.1: GLP and Cloud Computing
  Jun 2022	FDA	FDA draft Guidance Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
  Jun 2022	FDA	FDA draft Guidance Human Gene Therapy Products Incorporating Human Genome Editing
  Jun 2022	FDA	FDA Quality Metrics Reporting Program
  Jun 2022	WHO	WHO Global Model Regulatory Framework for Medical Devices including IVDs (GMRF)
  May 2022	FDA	Medical Devices; Quality System Regulation Amendments
  Mar 2022	ICH	Guideline Q9(R1) on Quality Risk Management, Step 2b
  Feb 2022	EMA	ISPE Response to the EMA Quality Innovation Survey
  Feb 2022	FDA	Inspection of Injectable Products for Visible Particulates

• 2021

  Dec 2021	EMA	ICH guideline Q13 on continuous manufacturing
  Nov 2021	EMA	Draft Guideline on Computerised Systems and Electronic Data in Clinical Trials
  Oct 2021	Health Canada	Post-Notice of Compliance (NOC) Changes – Quality
  Oct 2021	FDA	ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
  Sep 2021	MHRA	Consultation on Point of Care Manufacturing
  Jul 2021	EMA	Draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications
  Jul 2021	Health Canada	Issue Identification Paper: Drug-Device Combination Products (DDCPs) Draft for Consultation
  Jul 2021	PIC/S	Stakeholder Views on PIC/S 2022-2026 Strategic Plan
  Jun 2021	WHO	Guidelines on the Transfer of Technology in Pharmaceutical Manufacturing

• 2020

  Sep 2020	WHO	GMP Water for Pharmaceutical Use
  Sep 2020	WHO	Good Reliance Practices for Regulatory Decision-making for Medical Products
  Sep 2020	OECD	GLP Data Integrity
  Sep 2020	EMA	HMA  Network Strategy to 2025
  Aug 2020	WHO	Guideline on Data Integrity Rev 1
  Jul  2020	EC	Safe and Affordable Medicines Roadmap
  Jul  2020	EMA	Revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4
  Jan 2020	PIC/S	PIC/S GMP Guide Annex 2A and 2B
  Jan 2020	WHO	Guideline on Data Integrity

• 2019

  Sep 2019	EDQM	Ph. Eur. Commission general chapter on Multivariate Statistical Process Control (MSPC) (5.28)
  Sep 2019	WHO	Production of Water For Injection by Means Other Than Distillation Rev1
  Jun 2019	WHO	Good Storage and Distribution Practices
  Jun 2019	FDA	Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
  May 2019	EMA	Guideline on the Quality of Water For Pharmaceutical Use
  Apr 2019	WHO	Production of Water For Injection by Means Other Than Distillation
  Apr 2019	FDA	Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
  Mar 2019	PIC/S	Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
  Feb 2019	Health Canada	Cleaning Validation
  Feb 2019	Health Canada	Validating Drug Dosage Forms
  Jan 2019	FDA	Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions

• 2018

  Dec 2018	ICH	Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (submitted to USFDA)
  Oct 2018	FDA	Modernizing Pharmaceutical Quality Systems, Studying Quality Metrics and Quality Culture, Quality Metrics Feedback Program
  Sep 2018	FDA	Field Alert Report Submission: Questions and Answers; Draft Guidance for Industry
  Apr 2018	WHO	GMPs for Heating, Ventilation and Air- Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms: Part 2
  Mar 2018	EMA	Revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4
  Feb 2018	EMA	Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

• 2017

  Sep 2017	FDA	Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket
  Sep 2017	FDA	Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy; Draft Guidance for Industry
  Aug 2017	FDA	Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11-Questions and Answers
  Apr 2017	EMA	Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities'
  Mar 2017	FDA	Revised Draft Guidance Submission of Quality Metrics
  Mar 2017	FDA	Cross Industry Collaboration Group comments on Revised FDA Draft Guidance Submission of Quality Metrics

• 2016

  Nov 2016	EMA	Draft Q&A on Production of WIFI by Non-distillation Methods – reverse osmosis and biofilms and control strategies
  Nov 2016	MHRA	GxP Data Integrity Definitions and Guidance for Industry
  Sep 2016	FDA	Quality Metrics Technical Conformance Guide
  Sep 2016	FDA	Cross Industry Collaboration Group comments on Quality Metrics Technical Conformance Guide
  Sep 2016	EC	Consultation Document GMP for Advanced Therapy Medicinal Products
  Jun 2016	FDA	Draft Guidance Advancement Data Integrity and Compliance with CGMP Guidance for Industry
  Feb 2016	FDA	Draft Guidance Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry

• 2015

  Dec 2015	EMA	Reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)
  Nov 2015	FDA	FDA Federal Register Notice on Quality Metrics and Draft Guidance, Request for Quality Metrics
  Nov 2015	FDA	Cross-Industry Quality Metrics Collaboration Group comments on Request for Quality Metrics.
  Jul 2015	FDA	Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products
  Mar 2015	EMA	Annex 1 of the GMP Guidelines on Good Manufacturing Practice - Manufacture of Sterile Medicinal Products

• 2014

  Nov 2014	OECD	Application of GLP Principles to Computerised Systems
  Oct 2014	EMA	Process Validation for the Manufacture of Biotechnology-Derived Active Substances and Data to be Provided in the Regulatory Submission
  May 2014	FDA	Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics
  May 2014	EC	EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 15 - Qualification and Validation

• 2013

  Oct 2013	EC	EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 16 - Certification by a Qualified Person and Batch Release
  Sep 2013	WHO	General Guidance for Inspectors on “Hold-Time” Studies, Rev 1
  Sep 2013	WHO	Proposed Updated Text for Who Good Manufacturing Practices for Pharmaceutical Products: Main Principles
  Sep 2013	FDA	Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  Aug 2013	FDA	Guidance for Industry Expedited Programs for Serious Conditions––Drugs and Biologics
  Jul 2013	FDA	Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements
  Jul 2013	EMA	Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities
  Jul 2013	EC	Revision of EU Commission Guidelines on Good Manufacturing Practice Medicinal Products
  Apr 2013	EC	Guidelines on the Principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use
  Apr 2013	WHO	General Guidance for Inspectors on "Hold-Time" Studies
  Feb 2013	FDA	Draft Guidance for Industry on Safety Considerations for Product Design to Minimize Medication Errors (Docket No. FDA–2012–D–1005)

• 2012

  Oct 2012	EMA	Draft Guideline on Process Validation (EMA/CHMP/CVMP/QWP/70278/2012-Rev1)
  Oct 2012	SFDA	Regulations on Inspection and Administration of Drug Manufacturing Enterprises Oversea (Opinion Soliciting Draft) Document No. 82 2012
  Jan 2012	EMA	Concept Paper on the Development of Toxicological Guidance for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities (EMA/CHMP/SWP/598303/2011)

• 2011

  Sep 2011	FDA	Proposed revisions to USP General Chapter Good Storage and Distribution Practices for Drug Products
  Sep 2011	WHO	Comments on WHO Working Document, Definition of Active Pharmaceutical Ingredient (QAS/11.426 Rev 1)
  Sep 2011	EMA	ICH guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
  Sep 2011	FDA	ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) (Docket No. FDA–2011–D–0436)
  Jul 2011	WHO	Working Document Pharmaceutical Development of Multisource (Generic) FPP’s – Points to consider (QAS/08.251 Rev 3)
  May 2011	FDA	Guidance for Industry on Non-penicillin Beta-Lactam Risk Assessment: A CGMP Framework (Docket No. FDA-2011-D-0104)

• 2010

  Oct 2010	WHO	Working Document Good Practices for Pharmaceutical Microbiology Laboratories (QAS/09.297 Rev 2)
  Aug 2010	EMA	Guideline on Real Time Release Testing (Formerly Guideline on Parametric Release Testing) (EMA/CHMP/QWP/811210/2009 Rev 1)
  Aug 2010	WHO	Working Document Development for Multisource (Generic) Pharmaceutical Products (QAS/08.251 Rev 1)
  Aug 2010	WHO	Supplementary Guidelines on Good Manufacturing Practices for Heating Ventilation and Air Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms (QAS/10.342 Rev 1)

• 2009

  Dec 2009	WHO	Good Practices for Pharmaceutical Microbiology Laboratories (QAS/09.297 Rev 1)
  Oct 2009	WHO	Working Document, Manufacturing Practices for Pharmaceutical Products Containing Hazardous Substances (QAS/08.256 Rev 1)
  Oct 2009	WHO	GMP for Sterile Pharmaceutical Products (QAS/09.295 Rev 1)
  Apr 2009	ANVISA	Boas Prática de Fabricação de Medicamentos
  Jan 2009	FDA	Draft Guidance for Industry on Process Validation: General Principles and Practices (Docket No. FDA–2008–D–0559)
  Jan 2009	EMA	New Proposed Revisions to Annex 13 of Volume 4 EU Guidelines to Good Manufacturing Practice

• 2008

  Nov 2008	EMA	Proposed Revisions to Annex 13 of Volume 4 EU Guidelines to Good Manufacturing Practice
  Oct 2008	EMA	Proposed Revisions to Chapter 4 and Annex 11 of Volume 4 EU Guidelines to Good Manufacturing Practice
  May 2008	WHO	Guideline to the Inspection of Hormone Product Manufacturing Facilities (QAS/08.256)
  Apr 2008	WHO	Pharmaceutical Development for Multisource (Generic) Pharmaceutical Products (QAS/08.251)

• 2007

  Oct 2007	FDA	Draft Guidance on Q-10 Pharmaceutical Quality System CommentFDA2007-1011
  Aug 2007	EMA	Comments on Batch Release Certificates for Investigational Medicinal Products (IMPs)
  Mar 2007	EMA	EMEA Concept Paper Regarding Computerised Systems

• 2006

  Dec 2006	EMA	Guideline of Virus Safety Evaluation of Biotechnological Investigational Medicinal Products (EMEA/CHMP/BWP/398498/2005)
  Apr 2006	EMA	GMP Annex 1: Proposals for Amendment to the Environmental Classification Table for Particles and Associated Text, Amendment to Section 42 Concerning Acceptance Criteria for Media Simulations, Amendment to Section 52 Concerning Bio-Burden Monitoring, and Additional Guidance in Section 88 on the Sealing of Vials
  Apr 2006	FDA	Guidance for Industry on INDs – Approaches to Complying with cGMP During Phase 1 (Docket Number 2005D- 0286)
  Mar 2006	EMA	ISPE White Paper in Response to the EMEA’s Concept Paper, Dealing with the Need for Updated GMP Guidance Concerning Dedicated Manufacturing Facilities in the Manufacture of Certain Medicinal Products

• 2005

  Sep 2005	EMA	Sampling of Investigational Medicinal Products
  Apr 2005	EMA	Concept Paper Dealing with the Need for Updated GMP Guidance Concerning Dedicated Manufacturing Facilities in the Manufacture of Certain Medicinal Products (EMEA/152688/04)

• 2004

  Jul 2004

  FDA

  Part 11 revisions Electronic Records; Electronic Signatures; Public Meeting (Docket No. 2004N-0133)

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