Regulatory Focus™ > News Articles > 2022 > 5 > Euro Roundup: EMA moves to suspend 100 generic drugs over ‘flawed studies’ run by Indian CRO

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Posted 26 May 2022 | By Nick Paul Taylor 

Euro Roundup: EMA moves to suspend 100 generic drugs over ‘flawed studies’ run by Indian CRO

2765 The European Medicines Agency (EMA) is set to suspend around 100 generic medicines that came to market based on data from “flawed” bioequivalence studies run by the contract research organization (CRO) Synchron Research Services.
 
Officials at the US Food and Drug Administration stopped accepting data from studies by the Indian CRO last year over data integrity concerns. EMA’s Committee for Medicinal Products for Human Use (CHMP) recently completed its own investigation after seeing “irregularities” that “raised serious concerns about the company’s quality management system and the reliability of data from that site.”
 
CHMP found “no adequate bioequivalence data” for around 100 medicines tested by Synchron on behalf of companies in the European Union. Actavis, Johnson & Johnson, Mylan, Sandoz and Teva are on the list of marketing authorization holders with products recommended for suspension because they lack other sources of adequate bioequivalence data. The affected companies will need to provide alternative data to get the suspensions lifted, although there may be temporary reprieves for some products.
 
“Some of the medicines that have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State. Therefore national authorities can temporarily postpone the suspension in the interest of patients. Member States should also decide whether recalls of the affected medicines are needed in their territories,” EMA wrote.
 
A smaller number of companies, including Accord Healthcare, Jubilant Pharmaceuticals, Lupin and Mylan, were able to establish bioequivalence to the European Union reference product and as such can keep products on the market. CHMP found the companies had adequate data from other sources.
 
EMA Notice, More
 
MDCG shares guidance on the interface of clinical trial and diagnostic regulations
 
The European Commission’s advisory groups on medical devices and clinical trials have joined forces to answer questions about the interface of the new regulations in their respective areas of expertise.
 
 
Officials at the Medical Device Coordination Group (MDCG) and Clinical Trials Facilitation and Coordination Group (CTFG) created the question and answer document to address a guidance gap. While studies use assays, including tests not meant to be developed into commercial products, there is a lack of advice in the Clinical Trials Regulation and In Vitro Diagnostics Regulation (IVDR) on the topic.
 
The joint MDCG-CTFG document clarifies the requirements, explaining that IVDs used in clinical trials do not necessarily need to have a CE mark for the intended purpose. It is still possible to use in-house IVDs that lack CE marks in trials. IVDR also permits the use of “a device for a performance study according to the IVDR ongoing in parallel.”
 
Even so, assays that fulfill the definition of an IVD are subject to IVD legislation. Sponsors cannot bypass the legislation by stating an assay or other instrument, including software, is for research use only. Once the sponsor assigns a product a medical purpose and meets the IVD definition, it becomes subject to the legislation.
 
MDCG Guidance, More
 
MHRA posts advice on regulatory processes to manage medicine supply disruptions
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the regulatory processes to manage medicine supply disruptions.
 
In the guidance, the agency brings together information on the tools that are available to mitigate medicine shortages. The guidance explains that MHRA can fast track marketing authorization applications “if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine” verified by the Department of Health and Social Care.
 
The document links out to application tools and guidance for new marketing authorizations and product variation applications, before describing other ways to mitigate shortages. MHRA discusses temporary exemptions to labeling requirements, imports of licensed and unlicensed medicines, applications to vary licenses and options available to community pharmacies and wholesalers.
 
MHRA published the guidance against the backdrop of a high-profile shortage of hormone replacement therapy in the UK. The guidance references the shortage and actions MHRA has taken in response to the supply disruption.
 
MHRA Guidance
 
EMA mulls further changes to diabetes trial guidance after delay to earlier draft
 
EMA is seeking feedback on changes to the draft guideline on diabetes clinical trials that it released for consultation in 2018. Work on the text stopped because of EMA’s move to Amsterdam and COVID-19, and the pause has led the agency to identify other potential changes.
 
The agency set out its thinking in a draft reflection paper. After talks in CHMP, EMA is considering changing the data requirements with respect to confirmatory studies for certain claims in the wording of the therapeutic indication. EMA wants to know if a comparative study against metformin is still the right approach for getting an unrestricted monotherapy indication given changes in first-line treatment.
 
Other questions relate to combinations. Today, the common wording of the combination indication is “add-on to other glucose lowering agents” but some applicants have unsuccessfully sought an initial combination therapy indication. EMA is considering changing the indication to “in combination with other glucose lowering agents” and has put two options to the industry.
 
The draft reflection paper is open for comment until the end of August.
 
Draft Paper
 
MHRA creates guidance on backup supply route for getting drugs to Northern Ireland
 
MHRA has published guidance in the Northern Ireland MHRA Authorised Route (NIMAR). The UK government created NIMAR to enable people in Northern Ireland to access prescription-only medicines even if traditional regulatory routes cannot meet the need.
 
Brexit created a split between Northern Ireland and the rest of the UK. NIMAR is part of an attempt to address the situation. When there is a risk that a clinical need in Northern Ireland cannot be met, NIMAR permits the supply of prescription medicines in compliance with UK and EU rules. The pathway is open to medicines including those that are licensed in Great Britain but not in Northern Ireland.
 
If a medicine is on the NIMAR list, marketing authorization holders and wholesalers based in Great Britain can send it directly to end users in Northern Ireland. Alternatively, end users can access medicines via wholesalers based in Northern Ireland.
 
MHRA Guidance
 
NICE recommends mobile app-based, self-help insomnia treatment instead of sleeping pills
 
The UK National Institute for Health and Care Excellence (NICE) has recommended the Sleepio app as an effective alternative to sleeping pills for people with insomnia.
 
Sleepio delivers a digital six-week self-help program that features a sleep test and weekly interactive cognitive behavioral therapy for insomnia sessions. The sessions are intended to identify thoughts, feelings and behaviors that contribute to insomnia. Users also keep a diary about their sleeping patterns.
 
At £45 ($57) per person who starts session one of the program, NICE calculates that Sleepio saves money compared to sleeping pills and sleep hygiene in primary care. The calculation is based on data from nine sites that previously introduced the app.
 
Press Release
 
Other News:
 
EMA, the European Commission and the Heads of Medicines Agencies have published a report on the key performance indicators for the European clinical trials environment. The report covers the three months after the Clinical Trials Regulation became applicable. The number of applications submitted in the Clinical Trial Information System grew from nine in February to 29 in April. Joint Report

 

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