Euro Roundup: EMA proposes to suspend 100 generic drugs for ‘flawed studies’ conducted by Indian CRO

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The European Medicines Agency (EMA) is set to suspend around 100 generic drugs placed on the market based on data from “flawed” bioequivalence studies carried out by the contract research organization (CRO) Synchron Research Services.

United States Food and Drug Administration officials stopped accepting data from studies conducted by the Indian CRO last year on data integrity issues. EMA’s Committee for Medicinal Products for Human Use (CHMP) recently completed its own investigation after finding “irregularities” which “raised serious concerns about the company’s quality management system and the reliability data from this site”.

The 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 MAHs whose products are recommended for suspension because they lack other sources of adequate bioequivalence data. Affected companies will need to provide alternative data to get the suspensions lifted, although there may be temporary reprieves for certain products.

“Some of the medicines recommended for suspension may be of critical importance (for example due to the lack of available alternatives) in a given EU Member State. Therefore, national authorities may temporarily postpone the suspension in the interest of patients. Member states should also decide whether recalls of the affected medicines are necessary on their territory,” the EMA wrote.

A smaller number of companies, including Accord Healthcare, Jubilant Pharmaceuticals, Lupin and Mylan, were able to establish bioequivalence with the European Union reference product and thus keep the products on the market. The CHMP found that the companies had adequate data from other sources.

EMA Notice, After

MDCG shares guidance on the interface of clinical trial and diagnostic regulations

The European Commission’s Medical Devices and Clinical Trials Advisory Groups have joined forces to answer questions about the interface of the new regulations in their respective areas of expertise.

Officials from the Medical Devices Coordination Group (MDCG) and the Clinical Trials Facilitation and Coordination Group (CTFG) created the Q&A document to fill a gap in the guidance. While studies use tests, including tests that are not intended for development into commercial products, there is a lack of guidance in the Clinical Trials Regulations and the In Vitro Diagnostics Regulations (IVDR) on the subject.

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 their intended use. It is still possible to use internal IVDs without CE marking in the trials. The IVDR also makes it possible to use “a device for a performance study according to the IVDR in progress in parallel”.

Even so, tests that meet the definition of an IVD are subject to IVD legislation. Sponsors cannot circumvent the law by stating that a test or other instrument, including software, is for research use only. Once the sponsor allocates a product for medical purposes and meets the definition of IVD, it becomes subject to the legislation.

MDCG Guidelines, After

MHRA releases guidance on regulatory processes to manage drug supply disruptions

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued guidance on regulatory processes to manage disruptions in the supply of medicines.

In the guidance, the agency gathers information on the tools available to alleviate drug shortages. The guidelines explain that the MHRA can fast-track applications for marketing authorization “if there is compelling evidence of benefit in a public health emergency or if there is a supply shortage of a drug essential” verified by the Ministry of Health and Social Affairs.

The document links to application tools and guidance for new marketing authorizations and product change applications, before outlining other ways to mitigate shortages. The MHRA is discussing temporary exemptions to labeling requirements, imports of authorized and unlicensed medicines, license change applications and the options available to community pharmacies and wholesalers.

The MHRA issued the guidelines against the backdrop of a high-profile shortage of hormone replacement therapy in the UK. The guidelines refer to the shortage and the action the MHRA has taken in response to the supply disruption.

MHRA Advice

EMA considers further changes to diabetes trial guidelines after postponement of previous version

EMA invites feedback on changes to the draft guideline on diabetes clinical trials which it put out for consultation in 2018. Work on the text halted due to the EMA’s move to Amsterdam and COVID-19, and the hiatus led the agency to identify other potential changes.

The agency set out its thinking in a draft discussion paper. After discussions within the CHMP, the EMA is considering modifying the data requirements for confirmatory studies for certain claims in the wording of the therapeutic indication. The EMA wants to know if a comparative study against metformin is still the right approach to obtain an unrestricted monotherapy indication given the evolution of first-line treatment.

Other questions concern combinations. Today, the common wording for the combination indication is “adjunct to other hypoglycemic agents”, but some applicants have searched unsuccessfully for an initial combination therapy indication. The EMA is considering changing the indication to “in combination with other hypoglycaemic agents” and has offered two options to the industry.

The draft concept paper is open for comments until the end of August.

Draft paper

MHRA creates relief supply route guidelines to get drugs to Northern Ireland

The MHRA has published guidelines in the Northern Ireland MHRA Authorized Route (NIMAR). The UK government created NIMAR to enable people in Northern Ireland to access prescription-only medicines, even if traditional regulatory channels cannot meet the need.

Brexit has created a rift between Northern Ireland and the rest of the UK. NIMAR is part of an attempt to remedy the situation. Where there is a risk that a clinical need in Northern Ireland cannot be met, NIMAR allows the supply of prescription medicines in accordance with UK and EU rules. The way is open for drugs, including those which are authorized in Britain but not in Northern Ireland.

If a medicine is on the NIMAR list, UK-based marketing authorization holders and wholesalers can ship it directly to end users in Northern Ireland. Alternatively, end users can access medicines through Northern Ireland-based wholesalers.

MHRA Advice

NICE recommends stand-alone mobile app-based insomnia treatment instead of sleeping pills

The UK’s 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 offers a six-week digital self-help program that includes a sleep test and weekly interactive cognitive behavioral therapy for insomnia sessions. The sessions aim to identify the thoughts, feelings and behaviors that contribute to insomnia. Users also keep a diary of their sleeping habits.

At £45 ($57) per person starting the first session 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 have previously introduced the app.

Press release

Other news:

The EMA, the European Commission and the Heads of Medicines Agencies have published a report on key performance indicators for the European clinical trials environment. The report covers the three months following the entry into force of the Clinical Trials Regulation. The number of applications submitted to the Clinical Trials Information System increased from nine in February to 29 in April. Joint report

© 2022 Society of Regulatory Affairs Professionals.

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