Last week’s round-up;
21 – 25 September 2020

published 28 Sep 2020

Revision of ICH guideline Q3D on elemental impurities

Proposed changes to ICH Q3D have been issued by the EMA for consultation. The deadline for comments is 18 December 2020. The changes are as follows: • Raised PDEs for gold (all routes), silver (parenteral) and nickel (inhalation). • Corrected monographs for gold and silver. • New Appendix 5 on limits for elemental impurities by the cutaneous and transcutaneous route (previously the guideline covered only the oral, parenteral and inhalation routes)

EU suspension of ranitidine medicines confirmed

In April 2020, EMA recommended that all ranitidine medicines in the EU should be suspended due to the presence of low levels of the nitrosamine impurity NDMA, pending further investigation. The EMA has now re-examined its recommendation upon request from one of the companies marketing ranitidine in the EU. The recommendation holds, because the possibility of NDMA forming from ranitidine itself during the shelf-life of the product or inside the body is still being studied.

Ph. Eur. Parenteral Preparations Monograph Revision

The Ph. Eur. Commission has adopted the revised version of the dosage form monograph on Parenteral Preparations. The revised chapter describes the mandatory quality requirements for many pharmaceutical products in Europe and will be published in Supplement 10.5 of the Ph. Eur. on the 1st January 2021 and implemented by the 1st July 2021. Tests on particulate contamination for both visible and sub-visible particles are now described in the test section as release criteria. The tests apply to all liquid parenteral preparations intended for injection or infusion (including solutions, suspensions, emulsions or gels). A reference to general chapter 5.17.2 has also been included for additional guidance, and the test for visible particles has been included in the production section to ensure that parenteral preparations are kept free from visible particles during manufacture.

Other updates to the text have also been made and are described in the following article:

EMA Launches IRIS for use for scientific advice processes

IRIS is the European Medicines Agency’s (EMA) secure online platform where you can carry out certain regulatory procedures with EMA. To date this has been used for Orphan Designations, Parallel Distribution notifications, Innovation Task Force applications and to request a Research Product Identifier (RPI) for a new medicinal product. From 19 October 2020, EMA will require scientific advice applicants to use the IRIS platform to manage scientific advice processes with EMA. The procedures concerned are: Human domain: Initial and Follow-up Scientific Advice, Initial and Follow-up Protocol Assistance, Initial and Follow-up Qualification Procedure AND Veterinary domain: Initial and Follow-up Scientific AdviceFurther information on the IRIS platform and guides to registration can be found here:

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