Last week’s round-up; 25 – 29 May 2020
THE US FDA HAS FOUND NDMA IN METFORMIN PRODUCTS
The US FDA has found the carcinogenic nitrosamine impurity NDMA in several batches of extended-release (ER) formulations of metformin, which is used to treat patients with type 2 diabetes. The impurity was found to be above the acceptable limit in these products.
The agency has, therefore, called upon the five pharmaceutical companies involved to voluntarily recall these ER metformin products. Other metformin manufacturers which supply a large portion of the US market have not been affected by the recall. However, the FDA is collaborating closely with manufacturers to ensure appropriate testing for NDMA levels in these products. The agency is also conducting assessments to determine whether any shortages in metformin may arise due to the recalls, and it intends to help prevent or reduce the impact of any such shortages.
EMA Q&A: QUALIFICATION OF DIGITAL TECHNOLOGY-BASED METHODOLOGIES TO SUPPORT APPROVAL OF MEDICINAL PRODUCTS
The EMA has issued a Q&A document (June 2020) highlighting some key points for successful qualification of digital technology-based methodologies used in medicines development, for example as part of the conduct of a clinical trial. The Q&A reflects the EMA’s current experience, and notes that if a digital technology is used in the context of product development, evaluation or monitoring, and could impact the benefit-risk assessment, then relevant aspects will be discussed at product assessment (such as reliability versus established data capture methods), and so qualification should be considered during development. Examples are given of technologies falling within the scope of the qualification programme, and the process for requesting advice or an opinion is outlined. The Q&A ends with five overarching guiding principles for a qualification submission, and in particular the importance of early and focused interactions with the agency.
The document is available here: https://lnkd.in/d9u3iEH
MHRA – GCP FOR CLINICAL TRIALS
MHRA “Guidance Good clinical practice for clinical trials” gives guidance on how to show MHRA you’re meeting GCP standards and what to expect from an inspection. MHRA requests pre-inspection documentation information in the form of a GCP inspection dossier & a clinical trials spreadsheet within 30 days of notification of an inspection. The GCP dossier clinical trials spreadsheet which is used to prepare the GCP dossier and is part of the requested pre-inspection documentation was updated on the 22nd May 2020.
The updated GCP inspection dossier clinical trial spreadsheet can be viewed via this link https://bit.ly/3gs2BPB
PHARMACOKINETIC CONSIDERATIONS IN THE ASSESSMENT OF BIOSIMILARITY
What are the key pharmacokinetic considerations in the assessment of biosimilarity?
The EMA has updated question 7.1 of its Clinical Pharmacology and Pharmacokinetics Q&A, which tackles the above issue. The related response clarifies the differences between requirements for biosimilar products and small molecule generics. It provides further detail on the following issues that need to be considered in assessment of biosimilarity: linear clearance, nonlinear clearance, anti-drug antibodies, batch selection and protein content correction, study population, dose level, sampling times, and statistical comparison: https://bit.ly/RealCMC-2Aa1OCk
MEXICO HAS BEEN GRANTED PH. EUR. OBSERVER STATUS
Mexico has been welcomed as an observer state by the European Pharmacopoeia Commission.
Mexican authorities can now participate in the scientific work of the European Pharmacopoeia Commission and other activities of the European Directorate for the Quality of Medicines (EDQM). This brings the European Pharmacopoeia’s total observer countries to 30, together with the 39 European countries and European Union as signatory parties: https://bit.ly/RealCMC-2yzsTyv
WHO LAUNCHES NEW DIGITAL VERSION OF ITS MODEL LIST OF ESSENTIAL MEDICINES
The WHO has released a new digital version of its Model list of Essential Medicines (EML).
This WHO reference tool is currently used by over 150 countries to compile their national essential medicines lists to ensure that these essential medicines are always available in their health care system in the appropriate dosage forms and quality, and at affordable prices.
Users will now be able to freely access the EML online database on smartphones and computers. The system also allows users to create their own customized lists by exporting the list (or part thereof) into an Excel or Word version.