Regulatory Focus™ > News Articles > 2020 > 2 > EU Regulatory Roundup: Swissmedic Authorizes First Drug Under International Work Sharing Initiative

EU Regulatory Roundup: Swissmedic Authorizes First Drug Under International Work Sharing Initiative

Posted 27 February 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: Swissmedic Authorizes First Drug Under International Work Sharing Initiative

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Swissmedic Authorizes First Drug Under International Work Sharing Initiative
The Swiss Agency for Therapeutic Products (Swissmedic) has approved a drug under its international work sharing initiative for the first time. Swissmedic authorized Roche’s antiviral Xofluza for sale after working with its peers in Australia and Canada.
Health Canada and Australia’s Therapeutic Goods Administration (TGA) authorized three medicines under the work sharing initiative in 2018 and 2019. However, Swissmedic was not involved in those authorizations, despite being part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium that set up the work sharing initiative.
Swissmedic came on board for the fourth product reviewed by the ACSS initiative, working with TGA and Health Canada to assess a filing for approval of Xofluza. The Swiss agency took the lead on the review of the preclinical module of the filing, while TGA and Health Canada handled the clinical and quality sections, respectively. The agencies sent consolidated questions to Roche.
By pooling their resources, the three agencies were able to make independent decisions on whether to approve Xofluza after a review period of 265 days.
Swissmedic Notice
EU Makes Extensive Changes to Draft Rules on Sterile Product Manufacturing
The European Commission has made extensive changes to the draft rules on the manufacturing of sterile medicinal products in response to industry feedback. In light of the extent of the changes to the original draft, the Commission has released its revised version for a second consultation.
European producers of sterile medicines have operated under the same rules since 1971, with only targeted updates taking place in the decades since then. The Commission proposed a full review of the rules late in 2017, leading to submissions from around 140 organizations. Based on the feedback, the Commission made “substantial modifications” to the original draft.
The changes affect most parts of the document and in many cases entail the deletion or insertion of entire paragraphs. For example, the Commission has added new paragraphs on the transfer of materials, equipment and components into and out of cleanrooms and aseptic processing areas. Both versions call such transfers “one of the greatest potential sources of contamination,” but the revised draft spends more time discussing how to mitigate the risk.
Other changes include the revision of a section on sterilization by heat and moist heat sterilization. In updating the draft, the Commission has removed a line stating chemical and biological indicators of heat sterilization can be used in conjunction with physical measurements. The revised draft only discusses physical measurements.
The Commission is accepting feedback on the draft until 20 May. Officials have tasked 16 trade groups with sourcing and collating feedback from their members, reducing the likelihood that the Commission will end up with 140 sets of comments to sort through this time. Organizations that are not members of any of the trade groups can ask the Commission for a template for their feedback.
Commission Notice, Draft Document
EU Brexit Negotiation Mandate Targets Continued Trade in Medical Radioisotopes
The European Union has adopted negotiating directives that prioritize the ongoing trade in medical isotopes ahead of the start of talks about its future relationship with the United Kingdom.
Ahead of the planned start of talks about a post-Brexit trade deal, the EU has put together a text to guide its negotiators. The negotiating directives are light on specific points about the regulation and trade of therapeutics and medical devices in large part because most of the document is focused on higher-level issues such as the desire to agree on approaches that avoid unnecessary trade barriers.
The one specific point relevant to the medical sector is found in a section on civil nuclear issues. In the months and years after the Brexit vote, one oft-heard fear in the UK was that splitting from the EU would disrupt supplies of medical radioisotopes. The EU wants to avoid that outcome.
“The provisions on nuclear cooperation should facilitate trade in nuclear materials ..., including in relation to ... the supply of medical radioisotopes,” the EU wrote in its negotiating directives.
While both sides have discussed the benefits of ongoing trade and cooperation in the medical space, there remains potential for the negotiations to deliver an outcome that is disruptive for the industry. Notably, the failure to reach an agreement by the end of the year or agree to extend the deadline for concluding talks by the middle of the year could result in the UK leaving the EU without a deal.
Negotiation Directives
Denmark’s DKMA Reveals Hiring Surge at Medical Device Division
The Danish Medicines Agency (DKMA) has revealed it is part way through a trebling of the size of its medical device group. Having started 2017 with 12 device staff, DKMA expects to have a 40-person team in place soon.
DKMA revealed the sharp increase in its headcount in the latest version of its strategy for medical devices. The addition of details of DKMA’s hiring spree, which it framed as an effort to “massively” grow its capacity, is one of several changes to the old version of the strategy. DKMA also used the update to revise its list of strategic challenges.
The updated strategy identifies ensuring the effective implementation of new EU regulations as one of the most important strategic challenges facing DKMA. Elsewhere in the text, DKMA outlines plans to influence the interpretation of regulations, going as far as to state it must “continuously question if the existing framework for approval and market surveillance of medical devices is appropriate.”
What impact that will have in practice remains to be seen. In other areas, DKMA provides more concrete details of its plans, committing, for example, to the development of a Danish database for the active monitoring of device safety. DKMA plans to link the database to the EU-level EUDAMED.
DKMA Strategy
UK Government Seeks Applications for Position of MHRA Chair
The UK government is fielding applications for the post of chair of the Medicines and Healthcare products Regulatory Agency (MHRA). Officials want a chair who can build on MHRA’s international standing and lead it through changes necessitated by the UK’s split from the EU.
Michael Rawlins, the former chairman of the National Institute for Health and Care Excellence, has served as chair of MHRA since late 2014, when he began the first of his two three-year stints in charge of the UK regulator. However, MHRA is now seeking a new chair, putting out a call for applicants who want to work two to three days a week in return for £63,000 ($81,000) a year.
The appointment of a new chair will continue a period of churn at the top of MHRA. Ian Hudson stepped down as chief executive of MHRA last year after 18 years at the agency. Hudson’s departure coincided with the end of John Wilkinson’s time as director of devices at MHRA.
As the government notes in its advertisement for a new chair, the new leadership team is coming on board at a time of change for the agency. The government expects the incoming chair to work with the MHRA executive team to deliver “significant changes to fundamentally reshape the way the agency operates.” Exactly what changes are needed will depend on how the relationship between the UK and EU changes after Brexit.
The government is accepting applications until 17 March.
Press Release


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