Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA, EUnetHTA Create Gateway for Parallel Consultations on Marketing Authorizations, HTAs

European regulators and health technology assessment (HTA) bodies have advanced their plans to align the data sponsors need to win approval and secure reimbursement. The initiative takes the form of a gateway through which sponsors can request parallel consultations with the European Medicines Agency (EMA) and the HTAs of member states.

Today, sponsors can gain a marketing authorization only to learn HTAs are unwilling to pay for the drug on the basis the data that secured the EMA approval. This results in patients having to wait longer for new drugs. National HTAs have sought to remove some of the problems with the process through the European Network for Health Technology Assessment (EUnetHTA). This body has now teamed up with EMA.

The collaborators have created a platform sponsors can use to request input from EMA and HTAs. Once simultaneous requests for parallel advice are made to EMA and EUnetHTA, the latter will coordinate the involvement of national HTAs. Currently, sponsors must contact HTAs individually. The HTAs and EMA will then provide coordinated advice on the sponsor’s development plan. If the model works as hoped, it should lead to datasets that satisfy both EMA and HTAs.

“Our work with EUnetHTA aims to align our respective requirements as much as possible so that developers can generate one set of data that allows the assessment of both the benefits and risks of a medicine and its added value,” Guido Rasi, executive director of EMA, said.

Companies that take advantage of the service will hold face-to-face meetings hosted by two chairs, one from EMA, another from an HTA body. These meetings will discuss concerns the EMA or HTAs have with the sponsor’s trial design, plus any disagreements between the two agencies. The goal is to work through these disagreements to come up with a single trial design or development plan that satisfies all parties. The model includes time before and after the meeting for EMA and HTAs to discuss the proposal privately.

EMA and EUnetHTA have created a joint guidance document and joint templates to help sponsors access their advice. The guidance provides an overview of the concept, details the roles and remits of those involved and covers fees and other practical matters.

The agencies expect to process the first joint requests in September. EMA has put transitional arrangements in place for sponsors with pre-notified submissions in the interim.

Press Release, Joint Guidance

Commission Shares Position Paper on Post-Brexit Functioning of EMA

The European Commission has released a paper detailing its position on the functioning of EMA and other agencies after Brexit. Officials put together the document to inform talks with the team the United Kingdom has tasked with negotiating its split from the European Union.

Specifically, the position paper addresses a foreseen period in which EU has parted company with the UK but its “institutions, agencies and bodies” still have some residual activities in the former member state. The Commission expects these activities to disappear in time. Until that happens, it wants to ensure its people keep their rights, its secrets are maintained and its documents continue to be made available under existing EU law.  

The Commission has split the short document into three sections. One covers the privileges and immunities of EU agencies and their staff. The Commission wants the Brexit agreement to give EU bodies and their current and former staff “an equivalent level of protection as enjoyed before the withdrawal date.”

In the other two sections, the Commission addresses the need for the UK to continue to comply with EU secrecy and document sharing laws. The Commission expects the UK “treat any requests for access to these documents under the same conditions as under Regulation (EC) 1049/2001.”

Collectively, the negotiating points suggest the EU will push back against the UK if it tries to make the sort of fast, clean break from the Union’s laws and regulations favored by some people who support Brexit. 

The transparency of the EU team contrasts with the approach taken by UK politicians, who have largely avoided publicly declaring their position on key topics. That changed slightly this week when two senior politicians in the UK government outlined their hopes for drug regulation after Brexit. 

Position Paper, Regulatory Focus

EMA Creates Pre-Submission Checklist for Type II Variation Applications

EMA has released a pre-submission checklist covering type II variation applications. The checklist is designed to help companies ensure they have included all the information needed to inform the agency of changes that may significantly affect the quality, safety or efficacy of a product.

Officials are strongly encouraging companies to work through the checklist before submitting their applications. If a company can answer “yes” to all the questions on the checklist, its filing should contain all of the documents EMA needs.

The challenge of putting together such a comprehensive submission is shown by the length of the checklist. EMA uses 13 pages to lay out all the documents companies must submit, although not all the points apply to every filing. Documents covered by the checklist range from the cover letter to more specific requests, such as “confirmation that the worksharing application has been submitted to all [member states] concerned.”

Publication of the checklist reiterates EMA’s interest in using the format to tell people about their regulatory responsibilities. In recent years, EMA has released checklists covering type IB variation notifications, oral explanation preparations, the communication of safety issues to healthcare professionals, annual reassessments, five-year renewals and submissions related to conditional marketing authorizations.

EMA updated its post-authorization procedural advice for users of the centralized procedure in response to the publication of the checklist. The latest version points users to the checklist for help preparing type II variation applications.

Pre-Submission Checklist, Procedural Advice 

Swissmedic Readies eGov Service for Clinical Trial, Export Certificate Filings

The Swiss Agency for Therapeutic Products (Swissmedic) is preparing to introduce an eGov service that will move some regulatory activities online. Applications related to clinical trials, exemptions for non-conforming medical devices and export certificates are set to benefit from the service.

Switzerland has had an eGovernment strategy since 2007 and has a steering committee whose job it is to drive the implementation of its plans. Swissmedic stepped up its activities in the area late last year when it began pilot testing of an online submission platform. The plan to accept online versions of the aforementioned filings builds on these activities.

Swissmedic plans to unveil more details about its plans for online submissions in the third quarter.

The agency discussed its plans in a statement that primarily relayed details of its updated PDF forms. The new versions of the documents are dynamic. Swissmedic thinks this will make them easier to complete.  

Swissmedic Notice

Other News:

EMA has released a document discussing the development of cell-based advanced therapy medicinal products (ATMPs) that have not been substantially manipulated. The document uses such ATMPs to show the limitations and strengths of the risk-based approach to determining the extent of the data sponsors need to support applications for marketing authorization. Document

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has reclassified Maloff Protect anti-malaria tablets as an over-the-counter product. MHRA Statement