Synapse
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd, India
The European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Kharadi, India. This follows a good clinical practice (GCP) inspection carried out by the Spanish Agency of Medicines and Medical Devices (AEMPS) which raised serious concerns about the validity and reliability of study data generated at the CRO.
Having considered the findings of the GCP inspection, the Spanish medicines agency requested EMA’s human medicines committee (CHMP) to assess the impact on the benefits and risks of medicines that were authorised on the basis of studies performed at Synapse Labs’ facilities. EMA has also been requested to look at the impact on medicines currently being evaluated for authorisation that use study data generated at the CRO.
EMA will now review the available data to determine if any action is necessary to protect public health.
Key facts
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About this medicine
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|---|---|
| Approved name |
Synapse
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About this procedure
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| Current status |
Procedure started
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| Reference number |
EMEA/H/A-31/1529
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| Type | |
| Authorisation model |
Nationally authorised product(s)
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| Decision making model |
CHMP-EC
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Key dates and outcomes
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All documents
Procedure started
Synapse Article-31 referral - List of medicines concerned by the procedure (Annex I) (PDF/3.44 MB) (updated)
First published: 21/07/2023
Last updated: 07/09/2023
EMA/338956/2023 rev. 1
Synapse Article-31 referral - CHMP list of questions to be addressed by Synapse Labs located in Kharadi (PDF/175.83 KB)
First published: 21/07/2023
EMA/CHMP/304427/2023
Synapse Article-31 referral - Notification (PDF/503.4 KB)
First published: 21/07/2023
Synapse Article-31 referral - CHMP list of questions to be addressed by applicants and marketing authorisation holders (PDF/178.14 KB)
First published: 21/07/2023
EMA/CHMP/304426/2023
Synapse Article-31 referral - Timetable for the procedure (PDF/108.77 KB)
First published: 21/07/2023
EMA/CHMP/304425/2023
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.