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Final EMA Guidelines on Quality Requirements for IMPs

The final EMA Guidelines on the quality requirements for IMPs (pharmaceutical and biopharmaceutical drugs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. Many of the comments related to the question "What is a Non-substantial Modification?".

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FDA Guidance on CMC Change Management for Biologics and Notifications published

In December, the FDA published the final version of its "CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports" guidance, which addresses the reporting required for changes in the chemistry, manufacturing or controls of an already approved biological product.

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FDA Q&A Guidance on the Implementation of a Pathogen Reduction System for Blood Products

With the final publication of a guidance document on the implementation of a pathogen reduction system for blood components, the FDA complements its guidance documents on blood, blood products and plasma.

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FDA sends once again Untitled Letter to Manufacturers of Regenerative Therapies

With an "Untitled Letter" the FDA addresses again a manufacturer of regenerative therapies that does not meet the appropriate requirements for marketing such a product.

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APIC: Update of the ICH Q7 "How to do" Document

The latest version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalised and published on the APIC website in July 2021. It is also intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

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WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies

In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.

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COVID-19 Vaccines - Inspections under Emergency Approvals in the US

The GAO report details the number and frequency of FDA inspections of Covid-19 vaccine manufacturers and other biopharmaceutical manufacturers during the pandemic period.

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Regenerative Medicine Advanced Therapy (RMAT)- FDA explains which products fall under "RMAT"

By providing clarification on the designation "Regenerative Medicine Advanced Therapy" , the FDA is providing more clarity on which products may fall in this classification.

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FDA admonishes Regenerative Therapies Manufacturer in Untitled Letter

In an "Untitled Letter", the FDA requests information from a manufacturer of regenerative therapies based on umbilical cord stem cells on the approval status of the products distributed and used.

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Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal Products

In order to take account of the rapid development in the field of biological medicinal products and ATMPs, the PIC/S has revised Annex 2 of its GMP Guideline and made it available for comment.

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