Last week’s round-up;
19 – 23 October 2020
Reflection paper on pharmaceutical development for the geriatric population
The CHMP has adopted a reflection paper on the pharmaceutical development of medicines for use in the older population, which comes into effect as of 1st May 2021. The paper focuses on the design of medicines used in the elderly population, such as selecting appropriate routes of administration and dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and user instructions in the product information. Pharmaceutical developers are also encouraged to take a more patient-centred approach when developing medicines for the geriatric population. The EMA is seeking feedback from pharmaceutical developers who have applied the principles outlined in the reflection paper.
More details are available in the following link: https://bit.ly/RealCMC-3knv6Qb
Food contact materials safety and quality
The Committee of Ministers of the Council of Europe has adopted a new resolution on the safety and quality of materials and articles for contact with food, which supplements the relevant EU and national regulations. The aim of this resolution is to improve the protection of consumers from contaminants which may be released by materials in contact with food, including containers, work surfaces or packaging. Potential contaminants may include metals, antioxidants, stabilisers, colorants and plasticisers. The resolution also includes an annex with guiding principles for the implementation of suitable policies in member states and technical guidance for specific materials, such as paper and board, metals and alloys, coatings or silicones.
EMA: Qualification of novel methodologies for medicines development
The EMA has announced the latest process for which the IRIS platform should be used for applications. This is the process through which companies should apply for scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals.
Details, including links on how to access the IRIS platform can be found under this link: https://lnkd.in/eVNixXw
Nitrosamine testing of Metformin-containing medicines
The EMA and national competent authorities (NCAs) are now asking marketing authorisation holders for metformin-containing medicines to test their products for carcinogenic nitrosamine impurities prior to their release on the market. This precautionary step is in line with the measures introduced by EMA’s Article 5(3) review to limit the presence of nitrosamines in human medicines, and is aimed at ensuring patient safety while the Authorities’ investigation on the impact of tests which detect NDMA in metformin medicines is ongoing. The EMA and NCAs have advised that MAH responses to this request will be monitored and that action will be taken if required.
Useful paediatric formulations for possible COVID-19 treatment
The European Paediatric Formulary (PaedF) Working Party is currently compiling existing knowledge on paediatric formulations for active substances under investigation as well as known authorised medicinal products that may be used for the treatment of COVID-19. The information that is being gathered by the Working Party includes paediatric formulations of active substances used in clinical trials and also experimentally in clinical practice throughout the world. The information will be published in tables on the EDQM website and will be continuously updated. However, the PaedF Working Party has stressed that it is not in a position to verify the quality of the listed formulations due to the exceptional circumstances brought on by the COVID-19 pandemic and also due to the limited knowledge available. The PaedF Working Party and the EDQM have also highlighted that it is the prescriber that is responsible for making individual risk assessments for each patient before using these potential COVID-19 treatments.
Tables for Dexamethasone and Lopinavir/Ritonavir are currently available and may be viewed at the following link: http://bit.ly/RealCMC-349uHLj