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Euro Roundup: EMA posts draft guideline on labeling advanced therapy medicinal products

Posted 05 August 2021 | By Nick Paul Taylor 

Euro Roundup: EMA posts draft guideline on labeling advanced therapy medicinal products

The European Medicines Agency (EMA) is seeking feedback on its approach to the labeling of advanced therapy medicinal products (ATMPs) that contain genetically modified cells.
In the draft guideline, EMA describes the information it expects companies to include in the summary of product characteristics (SmPC), labeling and package leaflet for certain ATMPs. The draft applies to allogeneic and autologous cells genetically modified through methods including genome editing and viral vectors. EMA uses CAR-T cells and CD34+ modified cells as examples of the types of products covered by the guideline. 
The guideline gives a section-by-section breakdown of the information EMA wants to see included in the SmPC. For example, EMA is proposing that the strength of the medicinal product is expressed using the term “cells.” In the case of a CAR-T, EMA expects the strength to be determined by the total number of viable transduced cells. The information should be included in the section of the SmPC about the name of the medicinal product.
In the section on the qualitative and quantitative composition of the product, EMA wants companies to provide “a detailed description of the cells or tissues contained in the product and their specific origin.” The information should include the species of animal that provided the cells if they are of non-human origin. EMA has proposed specific wording for CAR-T and CD34+ cell products.
The guideline features similar section-by-section breakdowns of the information to include in the labeling and package leaflet. The guideline explains details such as how to handle the exemption of tissue and cell-based ATMPs from the need to carry unique identifiers.
EMA is accepting feedback on the draft until the end of October.
Draft Guideline
MHRA updates 16-year-old guide to defective medicinal products
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guide to defective medicinal products with information on the national patient safety alert (NatPSA) process.
MHRA published the earlier version of the guide in 2005. In updating the guide, MHRA has made changes to reflect the UK’s departure from the European Union and added a paragraph explaining how the Defective Medicines Report Centre (DMRC) assesses suspected defective medicinal products to sections aimed at patients and healthcare professionals.
“We will ask the company to investigate the suspected defect,” MHRA wrote. “The company are best placed to review the records of manufacture and packaging and have the analytical methods and equipment in place to test the complaint sample and retained samples. The DMRC will critically review the company’s investigation and testing results. If the investigation or testing is not satisfactory, then independent testing may be performed by the MHRA Laboratories.”
Elsewhere, MHRA has updated its approach to risk classification. MHRA used to categorize risk on the Class 1 to Class 3 scale used internationally. Now, MHRA uses NatPSA for defects that present a risk of death or disability, making it equivalent to the old Class 1. MHRA uses Class 2, 3 and 4 for lower-risk defects. The guide features an explanation of NatPSAs.
The document also features new guidance on letter drafting for marketing authorization holders. The new section, which points readers to documents including an EU pharmacovigilance guide, is intended to help write direct healthcare professional communications.   
MHRA Guide
MDCG creates guide to evaluating performance of COVID-19 tests
The Medical Device Coordination Group (MDCG) has published guidance on evaluating the performance of in vitro diagnostics designed to detect SARS-CoV-2 nucleic acid, antigens and antibodies against the virus.
In the guidance, which MDCG expects to form the basis for common specifications, the expert group provides general and overall considerations for the evaluation of SARS-CoV-2 tests before diving into the specifics for each type of product. The section of specific advice proposes acceptance criteria and the evidence needed to meet them for each type of test.
For antigen assays, MDCG has set the minimum positive sample detection rate at 80% for rapid tests and 85% for lab-based assessments. Developers should show tests meet the criteria by using them to analyze 100 samples that tested positive on a nucleic acid test, such as PCR, and were taken within seven days of symptom onset. MDCG has set the minimum sensitivity for rapid and lab-based tests at 98% and 99%, respectively, and expects the analysis to include potentially cross-reactive samples.
The guide features different acceptance criteria and data requirements for other types of SARS-CoV-2 tests, as well as additional requirements for antigen kits designed for self-use. MCGC expects lay users to interpret at least 100 contrived tests displaying a range of results.
MDCG Guide
France’s ANSM shares advice on new policy to stop shortages of devices and IVDs
The French National Agency for Medicines and Health Products Safety (ANSM) has published advice on incoming procedures for preventing shortages of medical devices and diagnostics.
Like the drug shortage policy discussed by ANSM last week, the new policy will take effect at the start of next month and place additional requirements on providers of products that are deemed to be essential. ANSM has published a decision-making flow chart covering the procedure for dealing with shortages and potential shortages of essential medicines and in vitro diagnostics.
ANSM expects manufacturers to use all the means at their disposal to prevent shortages. Manufacturers that are unable to prevent a supply disruption need to report the situation to ANSM so that alternative solutions can be found. ANSM has created a form manufacturers can use to inform it of disruptions to supply.
ANSM Notice (French)
Swissmedic benchmarks reveal closing of approval time gap versus FDA and EMA
The Swiss Agency for Therapeutic Products (Swissmedic) has benchmarked its approval times against those of its peers in the European Union and US. Greater use of accelerated authorization procedures slashed 20% off the total throughput time for all assessments of new active substances.
Total throughput time fell from 532 calendar days in 2019 to 427 calendar days last year. Swissmedic said it is “catching up” with EMA, which delivered a total throughput time of 395 calendar days.
The improvement was driven by greater use of accelerated procedures, which accounted for 25% of all assessments, up from 8% in 2019. Swissmedic’s total throughput time for standard procedures fell slightly but, at 535 calendar days, remains well above the level in the EU and, in particular, the US.
Project Orbis, the US-led cancer approval program, cut the time taken to evaluate additional indications. Swissmedic said it is “likely that the use of Orbis will bring about a lasting reduction in approval times for innovative medicinal products in the future.”
Swissmedic Notice
MHRA shares guidance for manufacturers of temperature screening devices
MHRA has shared guidance for manufacturers of devices used to screen the temperature of people in the context of the COVID-19 pandemic.
The guidance states manufacturers that claim their products are intended to screen humans for fever,  COVID-19 or other illnesses need to comply with regulations on medical devices. MHRA may regulate products with relevant claims even if the manufacturer includes disclaimers that they are not medical devices and cannot diagnose COVID-19.
MHRA typically regulates thermal cameras and digital thermometers intended for medical purposes as active medical devices. The agency categorizes active medical devices used to measure or monitor human body temperature as Class IIa products. 
MHRA Guidance


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