Ranitidine: Difference between revisions

 

In August 2020, the EMA provided guidance to marketing authorization holders for avoiding the presence of nitrosamine impurities and asked them to review all chemical and biological human medicines for the presence of nitrosamines and to test the products at risk.<ref name="EMA Nitrosamine impurities">{{cite web|date=6 August 2020|title=Nitrosamine impurities|url=https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities|access-date=6 August 2020|website=[[European Medicines Agency]] (EMA)|archive-date=4 August 2020|archive-url=https://web.archive.org/web/20200804183945/https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities|url-status=live}} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> In September 2020, the FDA issued guidance about the control of nitrosamine impurities in human drugs.<ref>{{cite press release|title=FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs|website=U.S. [[Food and Drug Administration]] (FDA)|date=1 September 2020|url=https://www.fda.gov/news-events/press-announcements/fda-provides-guidance-industry-detecting-and-preventing-nitrosamines-drugs|access-date=1 September 2020|archive-date=1 September 2020|archive-url=https://web.archive.org/web/20200901235705/https://www.fda.gov/news-events/press-announcements/fda-provides-guidance-industry-detecting-and-preventing-nitrosamines-drugs|url-status=live}}</ref><ref>{{cite web|date=1 September 2020|title=Control of Nitrosamine Impurities in Human Drugs|url=https://www.fda.gov/media/141720/download|access-date=1 September 2020|website=U.S. [[Food and Drug Administration]] (FDA)|format=PDF|archive-date=2 September 2020|archive-url=https://web.archive.org/web/20200902011837/https://www.fda.gov/media/141720/download|url-status=live}} {{PD-notice}}</ref><ref>{{cite report | date = September 2020 | title = Control of Nitrosamine Impurities in Human Drugs | url = https://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs | publisher = U.S. [[Food and Drug Administration]] (FDA) | page = | docket = FDA-2020-D-1530 | access-date = 24 June 2022 | archive-url = https://web.archive.org/web/20220601224600/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs | archive-date = 1 June 2022 | url-status = live | df = dmy-all}} {{PD-notice}}</ref> An implementation plan was issued in February 2021.<ref>{{cite report | url=https://www.ema.europa.eu/documents/referral/european-medicines-regulatory-network-approach-implementation-chmp-opinion-pursuant-article-53/2004-nitrosamine-impurities-human-medicines_en.pdf | title=European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines | date=18 February 2021 | id=EMA/425645/2020 | access-date=20 February 2021 | archive-date=4 July 2022 | archive-url=https://web.archive.org/web/20220704051404/https://www.ema.europa.eu/en/documents/referral/european-medicines-regulatory-network-approach-implementation-chmp-opinion-pursuant-article-53/2004-nitrosamine-impurities-human-medicines_en.pdf | url-status=live }}</ref>

 

==== List of recalls ====