With the U.K. still struggling to steer away from a no-deal Brexit, health regulators updated guidance this week for developers and manufacturers of medical products.
The Medicines and Healthcare products Regulatory Agency (MHRA) has added fresh advice on how a hard split from the European Union will affect certain types of marketing authorizations and the scientific advice process.
The U.K. position seeks to minimize disruption but will entail some changes for companies that use the pathways and services, including developers of drug-device combinations.
MHRA has built a growing body of advice on preparing for a no-deal Brexit as the U.K. has moved closer to exit day without agreeing to the terms of its departure from the EU. Originally, the U.K. was due to leave the EU Friday, March 29, but was granted a little more time to try to resolve the political logjam that could lead to a no-deal exit.
However, at the time of writing, a no-deal exit remains a distinct possibility. Authorities on both sides of the English Channel are preparing for that outcome while hoping that it never happens.
MHRA’s latest set of advice on a no-deal Brexit covers conditional marketing authorizations and the approval of products under exceptional circumstances. These approval pathways enable companies to bring products to market using limited datasets, either because they address a major unmet need or because the nature of the condition makes it impossible or unethical to trial the intervention.
The U.K. already has a scheme for authorizing products under exceptional circumstances that has the same eligibility criteria as its equivalent in the EU. However, the U.K. lacks a national conditional approval pathway.
As a no-deal exit will cut the U.K. off from the EU pathway, MHRA plans to create its own. The proposed pathway will use the same eligibility criteria as the existing EMA route. MHRA will also factor EMA’s conditional authorization decisions into its own assessments but will make the final decision independently of the EU-wide regulator.
Most products that come to market via truncated pathways are drugs that lack a significant device component but there are exceptions. In 2017, EMA granted conditional approval to Shire’s Natpar, a treatment for hypoparathyroidism that is administered via a product-specific reusable pen injector. Another example is BioMarin’s Brineura, a treatment for neuronal ceroid lipofuscinosis type 2 that is infused into the brain via a medical implant. Brineura is cleared for use in exceptional circumstances.
MHRA also used the update to confirm its scientific advice program will continue in the event of a no-deal Brexit. The only change is MHRA will exempt small and medium-sized enterprises from the advice fee. Topics MHRA offers advice about include “complex issues of drug/device combination products."