Last week’s round -up;
16-20 August 2021

published 23 Aug 2021

ATMPs containing genetically modified cells – draft EMA guidance on PI for consultation

The EMA has published for consultation a draft guideline detailing the information to be included in the Summary of Products Characteristics (SmPC), labelling and packaging leaflet for Advanced Therapy Medicinal Products (ATMPs) containing genetically modified cells. The purpose is to provide applicants and regulators with harmonised guidance on the requirements for the Product Information (PI); the consultation period ends on 31st October 2021.

Guidance link: 

The UK’s NICE has launched a consultation on Review of Methods and Processes for HTA Evaluation

NICE has just published a consultation on proposals for change as part of its methods and processes review. The consultation period is open for eight weeks. As newer more advanced technologies become available the outcome is intended to help simplify NICE’s approach and to allow more flexible decision-making. All while continuing to be robust and responsive.

Full details of the consultation and a short video outlining the proposed changes, can be found here:

New ICH Q13 continuous manufacturing guideline

The ICH has released a new draft ICH Q13 guideline on continuous manufacturing of drug substances and drug products, which is open for public consultation in Europe until the 20th December 2021. The new guideline covers continuous manufacturing (CM) of drug substances and drug products for both chemical entities and therapeutic proteins and may also apply to other biological/ biotechnological entities. It provides guidance on CM for new products, including generics and biosimilars, and also on the conversion of batch manufacturing to CM for products that are already on the market. The guidance focuses on the integrated aspects of a CM system in which two or more unit operations are directly connected, therefore, any changes made in a unit operation of CM may have a direct and often immediate impact on downstream and upstream unit operations. The main body of the guideline covers fundamental aspects of CM that are not specific to technology, dosage form, or molecule type. The annexes contain illustrative examples and considerations specific to certain modalities (e.g. chemical entities, therapeutic proteins), technologies, and production methods (e.g. integration of drug substance and drug product manufacturing).

Update on replacement for EMA electronic application forms (eAFs)

Further details have been released for the Digital Application Dataset Integration (DADI) project to replace the current pdf-based human and veterinary medicine eAFs, from 2022 onwards, with web-based forms on a portal. A summary presentation of the project, an updated questions and answers document, and a features list for the human variations form, are available on the eSubmission website.

Website link:

Clarity sought from the US FDA on ICH Q12 implementation

Following a public consultation, the US FDA has received several comments on its draft guidance on how ICH Q12 is to be implemented in the US. The ICH Q12 guideline facilitates the management of postapproval CMC changes for new and marketed pharmaceuticals and drug substances. Some members of pharmaceutical industry have asked the FDA to align reporting categories with the ICH Q12 guideline on postapproval changes. Other members seek clarity on how manufacturers can use postapproval change management protocols (PACMPs) to support a lower reporting category. Clarity has also been requested on whether the new guidance replaces the Agency’s guidance on established conditions (ECs) that was published in 2015 or whether the two guidelines should be used in conjunction.

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