Panexcell - referral

Current status

European Commission final decision

Overview

Panexcell Clinical Laboratories: suspension of medicines over flawed studies

On 24 July 2020, EMA’s human medicines committee (CHMP) recommended the suspension of the marketing authorisations of Panexcell Article-31 referral - Annex I tested by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India.

The recommendation came after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies. These are studies used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.

The inspectors found samples from different patients that were exceptionally similar and an instance of personnel documenting the wrong room temperature for the area where samples were being processed. These findings raise serious concerns about the company’s quality management system and the reliability of data from that site.

The CHMP looked at all medicines tested by Panexcell on behalf of EU companies and found none for which adequate data were available from other sources.

The Committee therefore recommended that all medicines authorised in the EU on the basis of bioequivalence studies conducted by Panexcell be suspended from the market. To lift the suspension, companies in the EU relying on data from Panexcell must provide alternative data demonstrating bioequivalence.

Medicines that were being evaluated for authorisation on the basis of data from Panexcell will not be granted authorisation in the EU.

EMA and national authorities will continue working closely together to ensure that studies on EU medicines are carried out to the highest standards and that companies comply with all aspects of Good Clinical Practice (GCP). If companies do not meet required standards, authorities will take whatever measures necessary to ensure the integrity of data used to approve EU medicines.

The CHMP's recommendation was sent to the European Commission for a legally binding decision.

Information for patients and healthcare professionals

• Some generic medicines are being suspended from the EU market because the company that tested them may be unreliable.
• There is no evidence of harm or lack of effectiveness with any of the affected medicines. However, the medicines will be suspended until supporting data from more reliable sources are available.
• Several alternative medicines are available. Patients taking the Panexcell Article-31 referral - Annex I can contact their doctor or pharmacist for more information.

More about the medicines

The review covers generic medicines authorised or currently being evaluated via national procedures on the basis of studies conducted by Panexcell Clinical Laboratories Priv. Ltd, India on behalf of marketing authorisation holders. The medicines were authorised or being evaluated for approval in Denmark, Finland, France, Germany, Malta, the Netherlands, Spain, Sweden and the United Kingdom¹. See Panexcell Article-31 referral - Annex I of the concerned medicines.

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¹As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period

More about the procedure

The review was initiated at the request of Germany under Article 31 of Directive 2001/83/EC. The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 24 September 2020.

Panexcell Article-31 referral - Panexcell Clinical Laboratories: suspension of medicines over flawed studies

Reference Number: EMA/547814/2020

Key facts

About this medicine

• Approved name:
  Panexcell
• International non-proprietary name (INN) or common name:
  • atazanavir
  • atazanavir sulfate
  • amoxicillin trihydrate
  • iron sucrose
  • amoxicillin
  • azithromycin dihydrate
  • carbocisteine
  • trimethoprim

About this procedure

• Current status:
  European Commission final decision
• 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.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• CHMP opinion date:
  27/02/2020
• EC decision date:
  24/09/2020

All documents

Procedure started

Panexcell Article-31 referral - Annex I

Draft Reference Number: EMA/116598/2020

Panexcell Article-31 referral - Notification

Panexcell Article-31 referral - Review started

Reference Number: EMA/95202/2020

Opinion provided by Committee for Medicinal Products for human Use

Panexcell Article-31 referral - CHMP list of questions to be addressed by the applicants/marketing authorisation holders

Reference Number: EMA/CHMP/91871/2020

Panexcell Article-31 referral - CHMP list of questions to the Clinical Research Organisation (CRO)

Reference Number: EMA/CHMP/106145/2020

Panexcell Article-31 referral - Timetable for the procedure

Reference Number: EMA/CHMP/92001/2020

European Commission final decision

Panexcell Article-31 referral - Annex I

Adopted

Panexcell Article-31 referral - Annex III

Panexcell Article-31 referral - Annex II

Panexcell Article-31 referral - Assessment report

Adopted Reference Number: EMA/504714/2020

Panexcell Article-31 referral - Panexcell Clinical Laboratories: suspension of medicines over flawed studies

Reference Number: EMA/547814/2020

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.