Regulatory News & Updates

Regulations, Guidelines & Other Documents

A select list of recently released regulations, guidelines and other documents compiled by the ISPE Regulatory Quality Harmonization Committee (RQHC)’s Europe-Middle East-Africa Regional Focus Group

November-December 2024

EMEA Regulatory Update – EMA: ESMP goes live !​
EMEA Regulatory Update – EMA: GMP update​
  • ​Annex 1 (Steriles)​
    • Guidelines on GMPs specific to ATMPs to be updated in the light of new Annex 1 : the work on Part IV has just started ​
    • PIC/S is working on a new Q&A document on Annex 1 (expected early 2025)​
      • SwissMedic Q&A published in 2024 – will be considered for integration to PIC/S Q&A​
  • Revision of Chapter 1 (Pharmaceutical Quality System)​
    • Work is in progress at IWG​
    • Objectives : to introduce risk management concerning drug shortages, add éléments from ICH Q9 and updated product quality review​
    • Draft for comments expected in 2025 ​
    • Target for a final Chapter 1: Q1 2026​
  • EU GMP Chapter 4 (Documentation) & Annex 11 (Computerized Systems)​
    • The revision aims at Developing EU level data integrity guidance by adapting existing published Q&A’s into GMP Chapter 4 and Annex 11 in collaboration with WHO and PIC/S​
      • Target date: Q1 2026​
    • Chapter 4: good progress. Draft chapter for consultation expected in 2025​
    • Annex 11: Good progress. A consultation expected soon in 2025
    • A new GMP Annex 22 could be established, dedicated to artificial intelligence​
  • EU GMP Annex 3 (Radiopharmaceuticals) & Annex 6 (medical gas)​
    • Both at very early stage. Reflection is on going, but no working group established yet. Target : Q4 2026​
  • EU GMP Annex 15 (qualification and validation)​
    • A working group has been set up this year and started reflection​
    • Should consider notion of risk management as defined in ICH Q9(R1) and its applicability to active substances (lesson learned from nitrosamines)​
    • Target :Q4 2026​
  • ​EU GDP Guide (Distribution)​
    • A new IWG Working Group (GDPWG) was created in September 2024 to focus on distribution​
    • Composed of experts in distribution from several national competent authorities​
    • Objective: support the IWG on any matter related to operational distribution​
    • 1st activity: write a Q&A on the fight against falsified medicines risk​
  • New Q&A on the ‘QP Declaration’​
    • Objective to clarify the approach for auditing and what constitutes a formal audit certificate​
    • Expected to be published Q1 2025​
  • Validity of GMP certificates:​
    • For sites in the EU/EEA, GMP certificate validity was automatically extended until the end of 2022, again in 2023 and again until end of 2024​
    • What about 2025? …Response came on 10 December (Letter from IWG to EFPIA):​
    • No further automatic extension of the validity date and that there is a return to the normal practice.​
    • National Competent Authorities will decide case by case whether any additional extension to a GMP certificate is applicable. ​
    • A Qualified Person should consult the issuing authority if the validity date of the GMP Certificate has passed. Issuing authorities will promptly deal with such consultations.​
  • EU-US MRA : scope extended to veterinary medicines (May 2023), the next planned extension was vaccines/plasma derived products : the work continues, but was slow down, so the initial date of July 2025 will be postponed (date??)​
FDA
  • ​FDA Issues Final Guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions​
  • This guidance is intended to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices. Additionally, this guidance provides the FDA’s current thinking on predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for an AI-enabled device software function (AI-DSF). ​
  • This final guidance:​
    • Represents the FDA’s next step in working to develop a tailored regulatory approach for AI-DSFs.​
    • Demonstrates the FDA’s broader commitment to develop and apply innovative approaches to the regulation of device software functions.​
    • Affirms that digital health technologies should be designed and targeted to meet the needs of diverse populations.​
    • Upcoming webinar on this guidance: On January 14, 2025, the FDA will host a webinar for industry and others interested in learning more about the final guidance.​
  • FDA Issues Guidance on Transitional Enforcement Policy for Ethylene Oxide Sterilization​
    • The FDA issued guidance, Transitional Enforcement Policy for Ethylene-Oxide-Sterilization-Facility-Changes-Class-III-Devices.pdf​
  • This guidance provides a transitional enforcement discretion policy for manufacturers of certain Class III devices to respond to anticipated changes in ethylene oxide (EtO) sterilization activities and helps to prevent or mitigate the potential risk of medical device supply chain disruptions or shortages during the time period in which sterilization facilities are transitioning to comply with new Environmental Protection Agency (EPA) requirements.​
  • The guidance provides recommendations for certain Class III device manufacturers whose devices are sterilized by EtO, and that might be or are affected by potential, actual, or temporary stop or reduction in operations at a sterilization facility, to implement certain types of sterilization site changes. ​
  • Some of the benefits of the guidance include:​
    • Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) holders of approved Class III devices sterilized by EtO may make certain sterilization facility changes prior to approval of a PMA or HDE supplement during this transition period.​
    • Enables the FDA to work proactively with manufacturers, developers, and other agencies to explore effective, efficient, and innovative solutions that will help maintain a strong supply of medical devices.​
    • Expedited sterilization site changes may reduce the impact of potential, actual, or temporary operation reductions at sterilization facilities.​
  • Strengthens supply chain resiliency and helps prevent and mitigate potential supply chain impacts.​
International​
  • Training materials for ICH Q13 have been officially published on the ICH website.​
    • The training materials for ICH Q13 have been officially published on the ICH website and can be accessed using the following link. In total there are12 modules which aim to facilitate an aligned interpretation and a harmonised implementation of the ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products Guideline in ICH and non-ICH regions by:​
      • Illustrating the general concept of Continuous Manufacturing (CM) process operation;​
      • Providing detailed clarification of novel scientific concepts and regulatory expectations pertinent to CM;​
      • Expanding discussion of Annex I-V in Q13 to address some specific CM implementation aspects relevant for different modalities.​
  • ICH Q9 (R1) Annex 1 - Q8/Q9/Q10 Q&A​
    • The updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers has been revised by removing outdated text and rephrasing the Q&As considered in view of the implementation of ICH Q8, Q9 and Q10, with minor additions to address minor content gaps in the document. Furthermore, minor edits have been made to improve the readability of the document.​


Brexit

A list of select Brexit updates compiled by the ISPE Regulatory Quality Harmonization Committee (RQHC)’s Europe-Middle East-Africa Regional Focus Group.

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