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Pharmaceutical

European sector spotlight

The Sedgwick brand protection recall index is the essential reference for pharmaceutical manufacturers seeking impartial and reliable perspective on past, present, and future product recall data and safety trends.

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European pharmaceutical recalls rose 48% in 2021 to 372 events, marking a return to pre-pandemic levels.

The latest edition of our highly coveted product recall index report offers a comprehensive year-in-review of 2021 pharmaceutical product recall data and trends, and insightful predictions for the remainder of 2022. It is the only report of its kind that aggregates and tracks essential data to help pharmaceutical business leaders mitigate litigation and reputational damage caused by product recalls and other in-market product incidents.

While we strongly recommend you download and read the whole index, the following excerpt provides a glimpse into the key insights and analysis from the pharmaceutical sector.

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+48%

pharmaceutical recalls rose in 2021

372

pharmaceutical events in 2021

123 events

safety concerns: leading cause of recalls

The European pharmaceutical landscape

As we enter into the third calendar year of the COVID-19 pandemic in 2022, the European pharmaceutical industry will continue to see its impact, especially as new variants emerge.

The new clinical trials regulation from the European Commission may complicate any efforts by non-EU companies to develop new vaccines. Now any sponsors or legal representatives of clinical trials involving EU citizens must be established in the EU. While the regulation aims to position the EU as a leader in clinical trials and increase innovation, it may also exclude American or UK companies from conducting trials. The UK has announced consultation on proposals for legislative changes for clinical trials in response, meaning additional regulations may be forthcoming.

At the beginning of 2022, a group of regulators from around the world met to discuss the global regulatory response to COVID-19 and the omicron variant under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The regulators met to align their efforts on key regulatory requirements for the development of additional vaccines for new COVID-19 variants. The meeting was described as part of a larger effort to begin a strategic discussion about what types of vaccines may be needed in the long term to manage COVID-19.

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Recall index report

Get unrivaled analysis and perspective on the latest pharmaceutical product safety trends and regulation.

Download the report

By the numbers: 2021 European pharmaceutical recalls

After seeing a 40% drop in European pharmaceutical recalls in 2020, the number of events rose 48% to 372 for 2021. The most common cause was safety, which accounted for 123 pharmaceutical recalls for the year. This was followed by failed specifications (56), quality (49), mislabelling (38), and foreign materials and contamination (35). This represents a big spike in product recalls for foreign materials and contamination, which were cited for only eight events last year.

France was the top country for both origin and notification of pharmaceutical recalls, with 108 in each category. The UK was second with 64 recalls both as the country of notification and the country of origin. There were no Class I recalls last year across the EU or the UK. Most (87%) were not assigned a Class. There were 20 pharmaceutical recalls classified as Class II, 11 as Class III, and 18 as Class IV for the year.

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Recall index report

Get unrivaled analysis and perspective on the latest pharmaceutical product safety trends and regulation.

Download the report

2022 strategic considerations

While product recall numbers are important, they are only part of the story. Here's what you should take away from pharmaceutical product safety developments in 2022:

  • The new EU Clinical Trials Regulation creates stricter boundaries for non-EU companies to participate in clinical trials in the EU, but will also increase transparency around how clinical trials are conducted. Do you know if your company meets the new requirements to participate in EU clinical trials? If not, are you prepared to take the necessary steps to establish a presence in the EU or otherwise find other places to conduct trials? Will the ease of being able to register trials in multiple countries from one online application change your testing strategy?
  • With the threat of new COVID-19 strains emerging, the pharmaceutical industry will be tasked with creating the vaccines and alternative treatments to tackle the virus and associated health risks. Will your company be prepared for continued regulatory scrutiny around these treatments? Have you considered whether future spikes in cases will affect supply chains and subsequently your business?
Contact us

Recall index report

Get unrivaled analysis and perspective on the latest pharmaceutical product safety trends and regulation.

Download the report

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Whether you’re planning for — or currently facing — a product recall, market withdrawal or any other in-market product incident, our experts are on hand to support you.

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