Euro Roundup: Onslaught of Brexit guidances from MHRA; Swissmedic's adverse event reporting challenges

RoundupsRoundups | 07 January 2021 |  By 

MHRA publishes 48 guidance documents on new regulatory regime
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published 48 guidance documents on the processes that will apply now that the Brexit transition period has ended.

Throughout 2020, MHRA published guidance on how drugs and medical devices would be regulated in the UK after Brexit. In the days before and after the transition period ended on 31 December, the agency released a flurry of updates and new documents to replace its earlier advice on what to do once the UK completed its split from the European Union.
The documents cover all aspects of drug and device regulation in the UK. Half of the documents relate to licensing matters, such as renewing marketing authorizations, licensing biosimilars, handling active substance master files and registering new packaging information.
Another tranche of the documents cover importing and exporting. The agreement of a trade deal that gives UK companies tariff- and quota-free access to the EU market eliminated one potential set of problems for importers and exporters, but the arrangement still creates barriers. Many of the import and export documents address supplying products in Northern Ireland, which remains subject to EU law.
MHRA published its set of documents alongside guidance from the National Institute for Biological Standards and Control (NIBSC), one of the regulator’s three centers. The NIBSC guidance addresses the changes caused by Great Britain’s departure from the EU Official Control Authority Batch Release (OCABR) program.
Until 31 December, manufacturers could use an OCABR certificate to provide biological medicines in Great Britain. OCABR certificates issued up to that date remain valid in the UK but all future batches will need to undergo certification at NIBSC. The only exceptions are products tested in countries with which the UK has mutual recognition agreements, namely Israel and Switzerland. The agreement with Israel only covers vaccines.
The changes could affect the number of batches NIBSC need to certify. NIBSC said it “will endeavor to meet current batch release turnaround times.” The laboratory plans to continue to accept samples ahead of documentation to help manufacturers meet their targeted release dates.   
MHRA Guidance, NIBSC Guidance
Swissmedic urges electronic adverse event filings amid ‘major challenge’
The Swiss Agency for Therapeutic Products (Swissmedic) has asked marketing authorization holders and healthcare professionals to use existing electronic tools to file reports of adverse drug reactions. Swissmedic made the request after identifying the rising number of reports as a “major challenge.”
Companies that submit more than 50 reports a year can use the E2B Gateway to share information on adverse drug reactions. Smaller companies and healthcare professionals can send reports via the ElViS electronic reporting system. The electronic reporting systems are well established, but some people and organizations continue to submit hard copies. That is creating problems for Swissmedic.
“The number of reports of adverse drug reactions has risen steadily in recent years,” Swissmedic wrote. “This presents a major challenge because Swissmedic must be able to keep processing this growing number of reports and identify any risks at a sufficiently early stage.”
Swissmedic wants companies and healthcare professionals to use the electronic systems to ease the pressures created by rising numbers of adverse event reports. However, Swissmedic has yet to prohibit the submission of hard copies, choosing instead to say companies and healthcare professionals may only send paper reports if electronic reporting is impossible.
The notice, which Swissmedic published on 1 January, precedes a potential surge in adverse event reports as Switzerland scales up a mass-vaccination campaign to end the COVID-19 crisis. Switzerland plans to vaccinate 70,000 people a day and, in doing so, protect 6 million of its 8.5 million residents against the coronavirus by July. The pace of the campaign could severely pressure reporting systems.
In a separate notice, Swissmedic asked healthcare professionals to register to use the ElViS electronic reporting system now to ensure they are equipped to submit adverse event reports related to the COVID-19 vaccines. Swissmedic said the use of ElViS, rather than hard copies, “guarantees the secure transmission of sensitive medical data and facilitates the prompt assessment of reports.”
Swissmedic Notice, More
UK, Canada agree to continue mutual GMP recognition on interim basis
Regulatory agencies in the UK and Canada have agreed to continue recognizing each other’s good manufacturing practice (GMP) and batch testing certificates. The interim agreement is intended to prevent Brexit-related disruption.
Trade between the UK and Canada was covered by the Canada-EU Comprehensive Economic and Trade Agreement (CETA) until 31 December. The UK’s involvement in CETA ceased when the Brexit transition period ended at the turn of the year, leaving it without a comprehensive trade agreement with Canada. An interim trade agreement is in place but is awaiting ratification by both sides.
The lack of a ratified trade deal has implications for the biopharma industry. CETA provides for the mutual recognition of GMP and batch testing certificates between the European Union and Canada. With the transition period ending, those provisions of CETA no longer apply to the UK.
To avoid disruption, MHRA and the Regulatory Operations and Enforcement Branch at Health Canada agreed on an interim arrangement. The agreement supports the continued recognition of certificates of GMP compliance issued by the other party and of batch testing certificates. Manufacturers with batch testing certificates will not need to undergo re-control when they import products.
The inclusion of batch testing makes the interim arrangement more comprehensive from a medicine manufacturing perspective than the trade deal between the UK and EU. While the UK-EU trade deal covers mutual recognition of GMP certificates, it lacks a comparable mechanism for batch testing, meaning products cleared in the UK may need to be tested again upon entry to the EU.
Over time, the interim UK-Canada arrangement will be replaced, first by the temporary agreement now awaiting ratification and eventually by a comprehensive free trade deal. Until then, the arrangement between MHRA and Health Canada will enable mutual recognition of certificates, the exchange of information and, if needed, the resolution of differences.
MHRA Notice
Swissmedic asks COVID-19 vaccinators to get 6 doses from Pfizer vials
Swissmedic has asked healthcare professionals administering BioNTech and Pfizer’s COVID-19 vaccine to get six doses out of each vial. The Comirnaty label states each vial contains five doses but through the use of “suitable syringes and careful handling” it is possible to withdraw a sixth dose.
The question of whether a sixth dose can be withdrawn from the vials arose in the US and UK in December. With the vaccine label stating a vial contains five doses, healthcare professionals initially discarded any material left after the administration of the firth shot. However, the US FDA and UK health service later clarified that a sixth dose can be withdrawn and used when possible.
Swissmedic issued its own notice on the topic this week. In the alert, Swissmedic asked healthcare professionals to try to get six doses out each vial given the limited number of vaccines currently available in Switzerland.
The agency offered advice on how to get a sixth dose, telling healthcare professionals to use syringes with a low dead volume. Healthcare professionals should only give the sixth shot if a full 0.3 ml dose can be withdrawn.
Swissmedic Notice


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