Last week’s round -up;
26-30 July 2021

published 4 Aug 2021

EMA issues new draft guidance on core SmPC, labelling and package leaflet for ATMPS

EMA has opened up a consultation from 30th July 2021 through to 31st of Oct 2021 on a new guidance for ATMPS containing genetically modified cells. The guideline seeks to describe the information to be included in the summary of products characteristics (SmPC), labelling and package leaflet and it is intended to apply to allogeneic or autologous, including viral vector modified and genome edited cells. Examples for Chimeric Antigen Receptor T (CAR-T) cells and Cluster of Differentiation 34+ (CD34+) modified cells are given in more detail. These can be used as model wording for other types of genetically modified cells.

The draft guidance can be found here: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. The new draft ICH Q13 consists of a main guideline and five annexes. The main guideline covers three different models of continuous manufacturing, and reviews control strategy and regulatory considerations. The three models of continuous manufacturing covered by the guideline include: 1. A combination of approaches in which some unit operations operate in a batch mode while others operate in a continuous mode 2. A model where all unit operations of a drug substance or drug product manufacturing processes are integrated and operate in a continuous mode 3. An approach in which the drug substance and drug product unit operations are integrated across the boundary between drug substance and drug product to form a single continuous manufacturing process. The annexes cover continuous manufacturing of drug substances, as well as continuous manufacturing of drug products, therapeutic protein drug substances, integrated drug substances and drug products and perspectives for managing disturbances.

Attention CEP Holders: New Draft Ph. Eur. Monographs

The following fifteen draft Ph. Eur. monographs, for which CEPs have been granted, have been published in Pharmeuropa 33.3:

• Amylmetacresol

• Calcium acetate

• Calcium ascorbate

• Cholecalciferol

• Clodronate disodium tetrahydrate

• Diclazuril for veterinary use

• Estriol

• Isoniazid

• Ondansetron hydrochloride dihydrate

• Pemetrexed disodium heptahydrate

• Propylthiouracil

• Raltegravir potassium

• RRR-alpha-Tocopheryl acetate

• Thiamine nitrate

• Tibolone

The EDQM has therefore asked CEP holders to consult the list of substances and provide feedback on the draft monographs before the 30th September 2021.

EMA issues new guidance on quality documentation required for medicinal products when used with a medical device

The EMA has finally issued new guidance that focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy (and hence overall benefit/risk determination) of a medicinal product.

The guidance covers; Medicinal products where the medical device and/or device part form an integral product that is not reusable; Medicinal products that are co-packaged with a device;  Medicinal products that are required to be used with a specific medical device.

The guidance which is effective from 1st Jan2022, can be found here :

EMA has updated pre-authorisation guidance for users of the centralised procedure

By the end of September 2021 any new sites and organisations to be registered for a Medicinal Product Marketing Authorisation will have to have to be registered in the EMA’s Organisation Management Service (OMS). This will be mandatory and EMA is keen to stress the importance of this site registration before the regulatory submission in order to avoid any delay in the start of the MAA process. If not applicants will be requested to register the site(s)/organisations during validation and prior to the start of the procedure. The guidance now also give detail instructions on the withdrawal of a request for submission of an MAA to EMA, if the applicant no longer wishes to submit an MAA.

The latest document with full details of the pre-submission guidance from EMA can be found here:

Upcoming ICH Analytical Guidelines

The ICH intends to release two new guidelines, ICH Q14 and ICH Q2(R2), which should allow manufacturers to switch analytical methods for testing medicines post-approval more easily and allow for better lifecycle management. The upcoming ICH Q14 guideline will harmonize scientific approaches to analytical procedure development to allow for a more efficient, sound scientific and risk-based approval. The ICH Q2(R2) guideline will replace the current ICH Q2(R1) guideline and will include some of the newer analytical procedures. Together the two forthcoming ICH guidelines should create a harmonized performance-based approach for allowing analytical method changes. The new ICH guidelines should be available for public consultation in December 2021.

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