Last week’s round -up;
14-18 December 2020
The Ph. Eur. Commission’s 168th session
The 168th session of the Ph. Eur. Commission was held between the 24th and 25th November 2020, during which the Commission adopted 114 texts for publication in Ph. Eur. Supplement 10.6, including 101 revised texts and 13 new texts. The new texts include several individual monographs and the following general chapters: Particulate contamination: sub-visible particles in non-injectable liquid preparations (2.9.53), Balances for analytical purposes (2.1.7), N-Nitrosamines in active substances (2.5.42) and Contaminant pyrrolizidine alkaloids (2.8.26). https://bit.ly/RealCMC-3mlABPs
Ph. Eur. Supplement 10.4 – Updates to CEP Applications
Ph. Eur. Supplement 10.4 is now available and CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st April 2021. More information and instructions may be found at the following link: https://lnkd.in/djqnXsJ
New & Updated Guidance available from UK MHRA
The UK MHRA has issued some new guidance regarding what clinical trial Sponsors need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland from 1 January 2021, and some updated guidance regarding the supply of authorised medicines to Northern Ireland during the period 1 January – 31 December 2021. They have also issued some new/updated guidance on how to register medical devices for the markets in Great Britain and Northern Ireland from 1 January 2021. Further information is available at https://www.gov.uk/
New policy for dissolution and disintegration testing in Ph. Eur. monographs
A new policy for dissolution and disintegration testing in Ph. Eur. monographs has been adopted by the Ph. Eur. Commission. A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form. Details of the scope of such a test and the conditions for its use in an MA application will be included in the General Notices (Ph. Eur. Chapter 1), which will be published in Supplement 10.6.
The revised General Chapter states that when a dissolution test is described in an individual monograph on a medicinal product, the applicant may either select the monograph dissolution test or develop an in-house dissolution test as the product-specific dissolution test. In either case, the applicant should also demonstrate the suitability of the selected test to the competent authority. Also, when tested, the medicinal product should comply with the monograph dissolution test, unless otherwise justified by the applicant. https://bit.ly/RealCMC-2Kb0Jzq
UK Public Assessment Report for the Pfizer/BioNTech COVID-19 vaccine added to MHRA website
UK MHRA has added the Public Assessment Report for the Pfizer/BioNTech COVID-19 vaccine (BNT162b2) to their website. Please use the link below to access the PAR for this vaccine, as well as the Information for Healthcare Professionals (Summary of Product Characteristics), the Information for UK Recipients (Patient Information Leaflet), and the Conditions of Authorisation under Regulation 174 of the UK Human Medicine Regulations 2012 (as amended). https://lnkd.in/dwE3SU7
EMA issues update to the guideline on Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, which becomes effective from 1st June 2021.
The original guideline was developed way back in 2010-2011, before the first gene therapy medicinal product based on genetically modified cells was authorised. Thus this revision reflects the significant experience gained since then. Novel technologies that were not even on the horizon in 2010 are now commonplace: including CAR-T cells, induced pluripotent stem cells and genome editing. Therefore, this revision incorporates guidance on genetically modified cells developed using these novel technologies. The updated guidance and the original guidance can be found under this link https://lnkd.in/eNz-4tK