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EU Regulatory Roundup: Swissmedic Streamlines Approval Process for Infectious Disease Vaccines

Posted 16 January 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: Swissmedic Streamlines Approval Process for Infectious Disease Vaccines

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Swissmedic Streamlines Approval Process for Infectious Disease Vaccines
The Swiss Agency for Therapeutic Products (Swissmedic) has changed its approach to authorization of innovative products to prevent communicable diseases. Having made the change, Swissmedic will allow companies with vaccines already approved in the European Union or United States to follow a streamlined approval pathway.
Swissmedic’s new approach effectively extends the flexibility it affords developers of orphan drugs to companies that want to bring certain vaccines to market in Switzerland. The pathway is open to new active substances approved in the EU or US for the “prevention of a communicable disease that can lead to serious harm or serious suffering with a potentially fatal outcome.” The filing for approval in Switzerland must cover the same indication in which the vaccine is authorized in the EU or US.
If a vaccine meets the criteria, Swissmedic will “scale back” its scientific review of the candidate on the request of the applicant. In practice, that means Swissmedic will use the reference authority’s assessment report to review the efficacy, safety and quality of the vaccine. Swissmedic will approve the vaccine if it concludes the anticipated benefits outweigh the risks.
The streamlined pathway, which became available at the start of the year, follows talks about how Swissmedic can make more use of foreign authorization rulings without jeopardizing patient safety. Swissmedic thinks the latest change is “helping to improve primary prevention and thereby contributing to the protection of public health.”
Swissmedic Notice, More
Finland Imposes Charge on Companies that Cancel Inspections
The Finnish Medicines Agency (Fimea) has added a fee for cancelling inspections as part of changes to the charges payable by pharmaceutical companies. Fimea is imposing the fee to cover costs incurred when companies cancel previously agreed inspections.
Under the new rules, Fimea will charge companies the fee payable for the first day of an inspection, plus travel expenses, “for each and every inspection cancelled on the operator’s initiative after the inspection was agreed upon in writing and the preparations were started.” The amount a company must pay will depend on the type of inspection that was canceled.
Under the new fee schedule, Fimea charges between €2,000 ($2,229) and €10,000 for the first day of an inspection. Overseas inspections of pharmaceutical or excipient manufacturers performed at the request of the operator carry the biggest fees.
Fimea imposed the new inspection cancellation fee as part of a broader update to its charges. The update features significant increases to multiple fees. For example, Fimea’s rate for the first day of a clinical trial inspection increased from €4,000 to €6,000. Fimea also increased the fee for subsequent days by 50%. Other changes include a more than 100% increase to the export certificate fee.
The agency offered detailed explanations for some of the changes, such as its decision to impose a €900 fee on sponsors for the processing of substantial amendments to clinical trials.
“The number of notifications of substantial amendments have constantly increased during the past few years. Trials have also become more complex than before, for which reason substantial amendments to the trial protocols are made increasingly more frequently in individual trials,” Fimea wrote.
Fimea Notice, More
Fimea Tracks 40% Increase in Drug Supply Disruptions in 2019
The number of product supply disruptions reported to Fimea increased 40% last year. Fimea thinks the increase may reflect an actual rise in the number of supply disruptions, as opposed to simply more comprehensive reporting of shortages.
Finland changed its reporting policy at the start of October. The change required manufacturers to send a notification for each pack size affected by a disruption. Previously, manufacturers could clump multiple pack sizes in single notifications. The change is likely to increase the number of notifications, but there are reasons to think other factors contributed to the 40% rise in reports seen last year.
By the time the new reporting rules came into force in October, Fimea had already received more notifications than across all of 2018. Over the first three quarters of 2019, Fimea received 138 supply disruption reports a month, on average. The number ticked up to 151 a month in the last quarter.
Viewed in light of trends seen in Finland and elsewhere in Europe in recent years, Fimea thinks the data points to an actual increase in the number of supply disruptions. Factors including the reduction in the number of suppliers of some products and the globalization of supply chains may explain the apparent increase in disruptions.
Fimea Notice (Finnish)
UK Discusses Plans to Make it Easier for Hospitals to Produce and Test Drugs
A representative of the United Kingdom government has outlined plans to make it easier for hospitals to produce and trial medicines.
The UK government raised the prospect of new, less onerous rules on the hospital-based production and trialling of medicines last year. That proposal survived the general election and, with the party advocating for the changes now having a big majority, looks set to become law in the future.
With both houses of parliament back in session, Baroness Redfern, of the ruling Conservative Party, set out how the government wants to change the rules placed on hospitals and otherwise help the life science industry.
“There is a need to reduce bureaucracy and make it easier for hospitals to manufacture and trial innovative medicines, thus helping to drive our global life sciences industries. New laws will be designed to help those industries to be internationally competitive. A process for the approval of drugs and devices will minimise the risks for national pharmaceutical companies if they choose to test and roll out new inventions elsewhere,” Redfern said.
Debate Transcript
Denmark’s DKMA Puts Data at Heart of 2020 Regulatory Strategy
The Danish Medicines Agency (DKMA) has set out its priorities for 2020. DKMA put becoming a data-driven medicines agency at the top of a list that also features points about drug shortages and optimizing work processes.
Evidence of DKMA’s focus on data emerged early last year when the Danish government backed the agency’s plans to create a data analysis center. With that center due to officially open in the first half of the year, DKMA plans to spend 2020 working to see data “used on a much larger scale for the benefit of people and patient safety.”
Elsewhere in its discussion of its priorities, DKMA outlined plans to focus on drug supply. DKMA has tracked an increase in supply disruption, both in Denmark and overseas, leading it to put strengthening “collaboration with both national and international players in the area to find long-term solutions to prevent shortages” on its list of priorities.
DKMA Statement
Other News:
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has shared details of a defect with Advanz Pharma’s Zapain. Advanz issued the alert after learning multiple batches of the codeine-based medicine shipped in packs that erroneously feature the word “capsules,” not “tablets.” As there is no risk to product quality, the packs are not being recalled. MHRA Notice
Swissmedic has tracked another increase in the number of adverse event reports related to animal medicines. In 2018, Swissmedic received 329 reports, an increase of 7.5% over the previous year. Most of the reports related to dogs. Swissmedic Notice


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