Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Expands Guidance on Assistive Technology to Help Device Industry
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has revised its guidance on assistive technologies, products that support people with disabilities, restricted mobility or other impairments.
MHRA published guidance on the definition and safe use of assistive technologies this time last year. That document provided examples of assistive technologies that are classed as medical devices and gave an overview of the safety issues associated with the class of products. However, the document was light on information to help developers of assistive technologies determine whether a product would be classed as a medical device for regulatory purposes.
The revised guidance, which is significantly longer than its predecessor, is intended to address that shortcoming and other gaps in the earlier advice provided by MHRA. To help companies understand the regulatory status of their products, MHRA has added a definition of medical device and unpacked what it means for developers of assistive technologies.
MHRA decides the regulatory status of assistive products by looking for “a direct link between the corrective function of the equipment and the individual concerned.”
In explaining what that means in practice, MHRA cited the example of two wheelchairs. One is used by porters to transport anyone around a hospital. The second is a self-propelled wheelchair for people with disabilities. Only the second product is a medical device, as the other wheelchair lacks a clear link between the corrective function and the individual.
“Unless a manufacturer specifies that a product is intended to be used by individuals for a stated medical purpose, the product could be used by anyone, regardless of whether they have a medical condition. If a product can be used by anyone then it is unlikely to be a medical device,” MHRA wrote. The guidance discusses walking sticks and cushions to further articulate the difference.
EMA Clarifies Position on Centralized Filings of Biosimilars and Generics
The European Medicines Agency (EMA) has updated its advice on the use of centralized filings for generics, hybrid products and biosimilars. EMA used the update to explain when a product constitutes a “significant therapeutic, scientific or technical innovation.”
In the old texts, EMA stated that developers of off-patent copies of medicinal products authorized via national, mutual recognition or decentralized procedures could ask to bring their therapies to market via the centralized pathway. However, EMA said it would only accept requests to use the centralized pathway if the applicant showed their product is a significant innovation or if its authorization at the European Union level was in the interest of patients.
The problem for applicants is the guidance offered no advice on how EMA would assess whether a product met those criteria. EMA’s update to the generic and biosimilar document provides those missing details.
EMA will consider a product a significant innovation if it offers a new alternative treatment, is based on “significant new scientific knowledge or on the application of a new scientific knowledge” or if a new technology — or a novel use of an existing technology — is used in its development or manufacturing.
Developers of generics, biosimilars and hybrid products that fail to meet those criteria can still use the centralized pathway if their product “addresses a specific health issue, allows access to medicines or provides another type of contribution to patient care in the Union,” EMA wrote.
EMA made one other change to its advice on generics and hybrid products. The revision changes the timetable for good clinical practice (GCP) inspections. EMA’s current position is that applicants will learn of a planned GCP inspection within 10 days of the adoption of an inspection request.
, Biosimilar Q&A
France to Adopt New Procedures for Processing National Approval Filings
The French National Agency for Medicines and Health Products Safety (ANSM) is set to adopt new procedures for processing national marketing authorization applications on 1 October.
ANSM has designed the procedures to ensure compliance with regulatory deadlines. If ANSM needs additional information to review a filing, it will give the applicant 14 days to submit the requested materials. ANSM will refuse to review applications from companies that fail to either hit the deadline or submit the information needed to complete the evaluation.
To cut the rate of substandard filings, ANSM is encouraging applicants to use the EMA’s checklist for centralized applications to confirm the completeness and compliance of their submissions.
Filings accepted by ANSM will undergo two rounds of evaluation, both of which provide the agency with the chance to send questions to the applicant. ANSM will give applicants three months, with the option of a three-month extension, to respond to the first set of questions. Applicants have 30 days to respond to the second set of questions.
Companies that make it through both evaluations without being rejected by ANSM will receive a draft marketing authorization five days before the agency finalizes its decision, giving them a chance to check the terms of the approval.
MHRA Drops Paper and Email, Restricting Communications to web Portals
MHRA has removed forms of communication including paper and email from the list of ways companies can submit information related to marketing authorization variations and licenses to sell medicines in the UK.
From now on, MHRA will only recognize the Central European System Platform and MHRA Portal as acceptable routes of submission. MHRA will reject filings made by another route. The agency attributed the change to a shift in the position of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
“To ensure compliance with the May 2019 update on CMDh requirements for MRP/DCP/NP submissions for new MAAs (CMDh/085/2008, Rev.21), as well as Variations and Renewals (CMDh/006/2008, Rev.20), the UK will no longer accept responses submitted via email, Eudralinks, paper or CD/DVD,” MHRA wrote.
, Authorization Guidance
Swissmedic Updates Guidance on Evaluation Reports, Veterinary Packaging
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on summary, public evaluation reports and the packaging of veterinary medicinal products.
Swissmedic’s revised position on evaluation reports affects the guidance on Swiss Public Assessment Reports (SwissPARs) that came into force at the start of the year. The revised document features extra information about the right to a legal hearing and new information about the Public Summary SwissPar, a version of the report that Swissmedic prepares for laypeople.
The changes were unveiled days after Swissmedic updated its guidance on the packaging of veterinary medicinal products, which also came into force at the start of the year. Swissmedic used the update to add a new section on type IB variations and to tweak its advice on the option for companies to make minor changes on their own initiative.
Companies must submit type IB regulatory variations for any change beyond what is permitted under the rules on using their own initiative. The section added by Swissmedic features examples of type IB variations, such as the “deletion, inclusion or modification of the name of the supplier company” and the “first inclusion of a pictogram or photos of the pharmaceutical form.”
Swissmedic has already brought the changes to both documents into force.
, Veterinary Guidance