Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Swissmedic Pilots Changes to Accelerate Drug Authorizations
The Swiss Agency for Therapeutic Products (Swissmedic) has begun pilot testing changes intended to speed up the drug authorization process. Swissmedic identified revisions to the labeling phase of the process as potentially having the most impact on authorization times by analyzing results from a four-year benchmarking study.
That study, which Swissmedic ran through a working group that included industry representatives, singled out the number of additional text review rounds in the labeling phase as a problem. Swissmedic thinks the inefficiency of this back-and-forth process means the labeling phase takes up a disproportionate amount of time and ultimately results in authorization assessments taking longer.
In response, the working group drew up proposals to improve the labeling phase. Having secured the approval of its management board to implement the changes, Swissmedic began pilot testing the new way of working on 1 October.
Some of the measures change how Swissmedic approaches the labeling phase. One such measure covers the feedback Swissmedic gives applicants on their information for healthcare professionals and packaging elements. In the case of the information for healthcare professionals, Swissmedic will now provide revised manuscripts at the same time as it shares its list of questions (LoQ).
Initiating the discussion about labeling in parallel to the LoQ is expected to lead to consolidation of versions of the information for healthcare professionals and patients in time for the preliminary decision.
Swissmedic also wants to provide feedback on cartons, blisters, labels and other packaging elements alongside the LoQ. However, to do so it will need applicants to submit definitive versions of their packaging materials alongside their initial submission. Working this way could reduce and bring forward the labeling rounds and, in doing so, ensure Swissmedic has reviewed and signed off on the packaging materials by the time it makes its preliminary decision.
The changes will affect applicants in other ways, too. Swissmedic is cutting the time companies have to respond to preliminary decisions and additional text review rounds from 90 days to 60 days. The agency plans to place a 30-day limit on responding to text review letters in the future. In some cases, Swissmedic will seek to bypass these lengthy reviews entirely by posing simple questions to applicants through the eGovernment portal. Applicants will have five days to reply.
Companies can request extensions and the 90-day labeling phase limit will remain the same in the pilot program.
If additional text review rounds extend the processing time but fail to yield changes to the product information texts, Swissmedic may issue an official decision directly. Swissmedic would take this decision without any further text review rounds. Applicants can appeal the decision in the courts.
Swissmedic will run the pilot test until it has enough evidence to judge whether the changes are practical and effective. If the impact of the changes falls short of Swissmedic’s expectations, the agency will either adapt or drop the measures.
Switzerland to Implement Cross-Border Inspection Law
Swissmedic has brought forward the implementation of a law on cross-border inspections. The law revising the conditions that must be met before foreign authorities inspect facilities in Switzerland will now come into force on 1 January 2018.
Swiss politicians voted in favor of the revised Therapeutic Products Act about 18 months ago, but are yet to implement the law. Some sections of the law are due to come into force at the start of next year but others are subject to an ongoing consultation. Changes covered by this discussion are expected to come into force on 1 January 2019, although that date could be pushed back by the outcome of the consultation.
Now, Swissmedic has acted to ensure implementation of a section on cross-border inspections is not delayed by discussions about other aspects of the law.
Once the section comes into force on 1 January 2018, foreign authorities will no longer need to gain clearance from the State Secretariat for Economic Affairs (SECO) before inspecting facilities in Switzerland. Rather, foreign authorities will just get the consent of the company to be inspected and comply with Swissmedic rules.
Those rules state the sole purpose of the inspection must be to assess compliance with therapeutic product legislation, and Swissmedic must be informed of the visit in advance. Swissmedic is also telling foreign regulators to send it the results of their inspections.
MHRA to Share Information With Fellow UK Regulator to Improve Oversight
The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to share certain information with another regulator in the United Kingdom. MHRA and healthcare service agency the Care Quality Commission (CQC) reached the agreement to address overlaps and gaps in their responsibilities.
With CQC and MHRA overseeing the safety and effectiveness of healthcare services and medical interventions, respectively, they each gather information that is potentially useful to the other. To ensure the more effective use of such information, CQC and MHRA have entered into a memorandum of understanding (MoU).
The non-binding document calls for the “lawful and proportionate” intra-agency sharing of any information that “indicates a concern about the health and wellbeing of the public.” This information could relate to a medicine, device, blood or the provision of a healthcare service.
Other sections of the MoU call for the regulators to try to tell each other about relevant planned public announcements and for their chief executives to meet annually to to “discuss strategic and operational concerns.”
MHRA Statement, MoU
EU Court Clears Commission of Wrongdoing in Disputed Original Appointment of Rasi
The General Court has cleared the European Commission of wrongdoing when it first named Guido Rasi as executive director of the European Medicines Agency (EMA) in 2011. Rasi’s appointment was annulled in 2014 following a complaint the court has now found to be meritless.
Reaching that conclusion led the General Court to dismiss the complaint entirely and order the complainant to cover the costs of the proceedings. That represents a victory for the Commission and EMA, which have fought over the issue since the now-defunct European Union Civil Service Tribunal forced Rasi out of the executive director role by annulling his appointment in 2014.
That legal ruling came two years after the former head of the Bulgarian drug agency, Emil Hristov, initiated proceedings. Hristov’s appeal followed the Commission’s decision to leave him off the shortlist of candidates for the executive director post.
The case left EMA without an executive director for 12 months while a new recruitment procedure was performed. Rasi reapplied for the post and was appointed for a second time. With the court now dismissing the complaint, the situation has returned to the state it was in before Hristov brought his case.
The Pharmacovigilance Risk Assessment Committee (PRAC) has reopened its review of the merits of modified-release paracetamol. PRAC called for such formulations to be pulled from the market last month over concerns about the treatment of patients who have overdoses. Now, some of the affected marketing authorization holders have appealed, forcing PRAC to re-examine the topic. EMA Notice MHRA
has issued a warning about the risk of an Alere
HIV test delivering false positives. The notice encourages healthcare professionals to take precautions before making diagnoses. MHRA Alert