Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
Nitrosamines: EMA aligns recommendations for sartans with those for other medicines
On 12 November 2020, EMA’s human medicines committee (CHMP) aligned recommendations for limiting nitrosamine impurities in sartan medicines with previous recommendations it issued for other classes of medicines.
The main change concerns the limits for nitrosamines, which previously applied to the active ingredients but will now apply instead to the finished products (e.g. tablets). These limits, based on internationally agreed standards (ICH M7(R1)), should ensure that the excess risk of cancer from nitrosamines in any sartan medicines is below 1 in 100,000 for a person taking the medicine for lifelong treatment.
In line with previous recommendations, companies should have appropriate control strategies to prevent or limit the presence of nitrosamine impurities as much as possible and, where necessary, improve their manufacturing processes. Companies should also evaluate the risk of nitrosamines being present in their medicines and carry out appropriate tests.
Nitrosamines are classified as probable human carcinogens (substances that could cause cancer). In the vast majority of sartan medicines, these impurities were either not found or were present at very low levels.
The CHMP concluded its review of sartan medicines in January 2019. The committee subsequently conducted a wider review, taking into account the experience from sartans and other medicines where nitrosamines were detected. The revised conditions companies need to fulfil for sartans brings them in line with those for other classes of medicines issued in June 2020.
EMA will continue working with national authorities and the European Commission to ensure that companies are taking all necessary measures. EMA will also continue its close cooperation with the European Directorate for the Quality of Medicines & HealthCare and international partner agencies.
Key facts
About this medicine
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Approved name |
Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
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International non-proprietary name (INN) or common name |
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Associated names |
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Class |
angiotensin-II-receptor antagonist
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/A-31/1471
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Type | |
Authorisation model |
Centrally and nationally authorised products (mixed)
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Key dates and outcomes
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CHMP opinion date |
12/11/2020
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EC decision date |
19/02/2021
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All documents
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)
First published: 02/03/2021
EMA/47245/2021
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Annex I (PDF/83.35 KB)
First published: 17/05/2019
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)
First published: 02/05/2019
EMA/217823/2019
Procedure started
Valsartan Art 31 - list NAPs and CAPs (PDF/2.2 MB)
First published: 27/07/2018
Last updated: 17/05/2019
EMA/480845/2018 rev2
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP list of questions to be addressed by the API manufacturers for valsartan-containing medicinal products (PDF/79.25 KB)
First published: 17/07/2018
Last updated: 17/07/2018
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Notification (PDF/90.13 KB)
First published: 17/07/2018
Last updated: 17/07/2018
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP list of questions to be addressed by the marketing authorisation holders for valsartan-containing medicinal products (PDF/79.49 KB)
First published: 17/07/2018
Last updated: 17/07/2018
Under evaluation
Olmesartan Art 31 - list of NAPs (PDF/1.89 MB)
First published: 04/10/2018
Last updated: 17/05/2019
EMA/662763/2018
Losartan Art 31 - list of NAPs (PDF/1.73 MB)
First published: 04/10/2018
Last updated: 17/05/2019
EMA/662730/2018
Irbesartan Art 31 - list of NAPs and CAPs (PDF/1.38 MB)
First published: 04/10/2018
Last updated: 17/05/2019
EMA/662946/2018
Candesartan Art 31 - list of NAPs (PDF/1.66 MB)
First published: 04/10/2018
Last updated: 17/05/2019
EMA/662693/2018
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Notification (extension of scope) (PDF/66.56 KB)
First published: 04/10/2018
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP list of questions to be addressed by the marketing authorisation holders for valsartan-containing medicinal products (PDF/92.74 KB)
First published: 04/10/2018
EMA/CHMP/668547/2018
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP list of questions to be addressed by the API manufacturers for valsartan-containing medicinal products (PDF/92.74 KB)
First published: 04/10/2018
EMA/CHMP/668548/2018
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - EMA review of impurities in sartan medicines (PDF/66.76 KB)
First published: 21/09/2018
EMA/643116/2018
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Timetable for the procedure (PDF/74.28 KB)
First published: 17/07/2018
Last updated: 18/12/2018
EMA/CHMP/466973/2018 rev.2
Opinion provided by Committee for Medicinal Products for Human Use
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Nitrosamines: EMA aligns recommendations for sartans with those for other medicines (PDF/117.21 KB)
First published: 13/11/2020
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Timetable for the procedure - CHMP Opinion on the impact of the Article 5(3) referral on nitrosamines in human medicinal products on the referral (PDF/115.46 KB)
First published: 20/10/2020
EMA/CHMP/525148/2020
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities (PDF/99.94 KB)
First published: 01/02/2019
Last updated: 28/05/2019
EMA/248364/2019 Rev.1
European Commission final decision
Angiotensin-II-receptor antagonists (sartans) Article 31 referral – Annex II – Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/122.17 KB)
First published: 19/03/2021
Angiotensin-II-receptor antagonists (sartans) Article 31 referral – Annex I – Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/95.85 KB)
First published: 19/03/2021
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Annex II (PDF/59.81 KB)
First published: 17/05/2019
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
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13/11/2020
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
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01/02/2019
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19/11/2018
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15/10/2018
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28/09/2018
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21/09/2018
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21/09/2018
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13/09/2018
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20/08/2018
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10/08/2018
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02/08/2018
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17/07/2018
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05/07/2018
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