With No-Deal Brexit Looming, UK and EU Regulators Urge Timely Action from Drug Makers

As the United Kingdom continues to move toward its exit from the European Union without an agreed-upon deal, the UK National Institute for Biological Standards and Control (NIBSC) has issued new guidance for manufacturers of biologics in preparation for a no-deal Brexit.

In the event of a no-deal scenario, the United Kingdom will no longer be subject to EU rules, and NIBSC will become a stand-alone entity. The United Kingdom will require NIBSC to certify batches of biologics before they can be placed on the UK market for any batches that were not certified by the European Union prior to March 29 (though exceptions will be made for batches manufactured and released in Switzerland and Israel, with whom the United Kingdom shares mutual recognition).

After March 29, the United Kingdom will carry out its own batch release of biologics, taking a risk-based approach to laboratory testing. In cases in which no certificates issued by a laboratory on an approved list are available, NIBSC will carry out its own laboratory assessments. NIBSC will use new statutory fees to fund its work.

If drug makers want to market batches of biologics in the United Kingdom after March 29 and they have not already been certified, drug makers will need to send samples and documentation for batches that will be sold in the UK market to NIBSC. While NIBSC will try to meet batch release turnaround times, the institute urges the early submission of documentation, and invites developers to contact NIBSC about interim arrangements that may be necessary for some products.

Also this month, the European Medicines Agency (EMA) issued a new communication to drug makers seeking Brexit-related Type 1 variations to their marketing authorizations. These variations are changes to authorizations that have little or no impact on the quality, safety, or efficacy of medicinal products. The EMA urged drug makers to file their Brexit-related variations as early as possible in March to allow the EMA to process all submissions (and issue confirmation of compliance with regulatory and legal requirements) before March 29.

The EMA says it expects to see more than a 50% increase in the number of variations filed over the next 3 months as companies submit Brexit-related changes to their marketing authorizations.

The new communications come with just 1 month left before Brexit. Recently, during the Medicines for Europe 18th Regulatory and Scientific Affairs Conference in London, United Kingdom, held from January 31 to February 1, a representative from the EMA told meeting attendees that only 27% of all affected centrally authorized products had completed all necessary pre-Brexit changes. As of November 2018, there were 19 products for human use that appeared to be at risk of not making changes in time.