Regulatory Digest - August 2022

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.

Are you ready to implement ICH Q9(R1)?

Are you ready to implement ICH Q9(R1)?

That question was at the heart of ISPE’s recent Expert Xchange: Regulatory Summit on ICH Q9 Revision. Participants had an unparalleled opportunity to hear from several members of the ICHQ9 (R1) Expert Working Group how many of the public comments made on the guide were being addressed and discuss implementation of the revision’s key focus areas. Read More

ISPE will present its next Expert Xchange: Regulatory Summit on 14 September which will focus on Modernizing Inspections. Read More

ATMP Regulations: Comparison of EudraLex Part IV with PIC/S Annex 2A

It is not surprising that there are regulations and guidance specifically for ATMPs such as EudraLex Volume 4, Part IV (EMA) and PIC/S Annex 2A. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines. Read More

ATMP Regulations - Comparison of EudraLex Part IV with PIC/S Annex 2A

FDA’s Approach to Advancing Quality Surveillance: PQS Effectiveness, Post-Market Quality Surveillance, Quality Metrics and Quality Management Maturity

FDA’s Approach to Advancing Quality Surveillance

A presentation at ISPE’s European Annual Conference illustrated the Agency’s use of advanced analytics to enhance an overall proactive quality surveillance framework. The presentation revealed how the integration of data from Establishment Inspection Reports, Field Alert Reports, and other sources can help the Agency proactively identify potential quality signals and trends. Read More

European Medicines Agency Approach to Facilitating Innovative Manufacturing Approaches

EMA on Facilitating Innovative Manufacturing

Innovation is a key strategic priority for the EU Regulatory Network. A presentation by the EMA at ISPE’s European Annual Conference outlined the agency’s plans to facilitate innovation and foster an attractive competitive environment to host sites using advanced manufacturing technologies for EU and global supply. Read More

Continuous Manufacturing of Drug Substance vs Drug Product

Contrasting Drug Substance and Drug Product Continuous Manufacturing

A recent blog highlights some of the differences between small molecule Drug Substance and Drug Product continuous manufacturing (CM), which may be helpful in considering the development and execution of CM for pharmaceutical manufacturing. Read More

ISPE’s Asia-Pacific Regulatory Group Re-established

The group will focus on topics such as the requirement in some AP markets to register excipient and packaging suppliers, import testing requirements, reliance pathways, acceptance of ‘global’ drug substance starting materials, renewal requirements, and more. Read More

Regional ISPE Regulatory Quality Harmonization Committee Focuses on Issues in the Asia-Pacific

Quality and Regulatory Challenges, Learnings, and Future Opportunities

Quality and Regulatory Challenges, Learnings, and Future Opportunities

The Regulatory and Quality sessions to take place at the 2022 ISPE Annual Meeting & Expo 30 October – 2 November will cover regulatory and quality challenges, learnings, and opportunities, such as building a quality organization, quality management maturity, development and implementation of new and emerging ICH guidelines, and regulatory considerations to boost innovation and supply chain resilience. Read More

ISPE Comments on Draft Guidelines

ISPE provides the opportunity for members to propose comments on selected draft regulatory guidelines or guidances. Commenting opportunities are published in the Regulatory and Quality Networking Community.

ISPE recently submitted comments on:

  • FDA draft Guidance Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
  • FDA draft Guidance for Human Gene Therapy Products Incorporating Human Genome Editing
  • FDA Medical Devices; Quality System Regulation Amendments
  • FDA Quality Metrics Reporting Program
  • ICH Q14: Analytical Procedure Development
  • ICH Q2 (R2): Validation of Analytical Procedures
  • OECD draft Advisory Document No. 17. Supplement No.1: GLP and Cloud Computing
  • WHO Global Model Regulatory Framework for medical devices including 4 IVDs (GMRF)
  • Read these and other ISPE comments