European sector spotlight

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.

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?