Panexcell

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Under evaluation

Overview

The European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India. This follows a good clinical practice (GCP) inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the EU. The inspection was carried out jointly by Austrian and German authorities in October 2019 in the context of the evaluation of an application for marketing authorisation of a medicine.

Having considered the inspection findings, the German medicines agency (BfArM) requested EMA to assess the impact of these findings on the benefits and risks of medicines that have been authorised in the EU on the basis of studies performed by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai. EMA has also been requested to look at the impact of the findings on medicines currently being evaluated for authorisation.

EMA will now review the available data to determine if any action is necessary to protect public health.

Key facts

Approved name
Panexcell
Reference number
EMEA/H/A-31/1494
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
Under evaluation
Opinion date
27/02/2020

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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