Regulatory Focus™ > News Articles > 2019 > 11 > EU Regulatory Roundup: Swissmedic Details Plans to Align Combination Product Rules With EU

EU Regulatory Roundup: Swissmedic Details Plans to Align Combination Product Rules With EU

Posted 07 November 2019 | By Nick Paul Taylor 

EU Regulatory Roundup: Swissmedic Details Plans to Align Combination Product Rules With EU

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Trade Group Calls for EU to Cut Review Times for ATMP Clinical Trial Filings
The Alliance for Regenerative Medicine (ARM) has called for Europe to streamline approval of clinical trials of advanced therapy medicinal products (ATMP). ARM wants regulatory agencies to cut review timelines and harmonize their approaches to support development of cell and gene therapies.
Europe has played a central role in the emergence of ATMPs. The European Medicines Agency (EMA) approved a gene therapy long before its regulatory peers and was the first authority to adopt specific rules covering the development and approval of the nascent class of medicines. However, a survey of ATMP developers run by ARM suggests the European Union may be losing ground as a destination for clinical trials.
The survey found clinical development activity in Europe is flatlining, with sponsors starting 2% more trials in 2018 than in 2014. In contrast, the number of clinical trials initiated in North America and Asia rose by 36% and 28%, respectively, over the same period.
There is evidence that the trend cannot be explained by the relative sizes of the ATMP sectors in each region. The number of ATMP developers in Europe is around half that of North America. Yet, Europe is home to around one-third as many clinical trials as North America.
ARM thinks the regulatory environment may be contributing to the relative lack of clinical trials in the EU. Respondents to the survey cited speed of approval and the quality of review and expertise at health authorities as two of the top three criteria for selecting the location of a clinical trial site.
The outgoing clinical trial directive permits regulators to take longer to adjudicate on filings to study ATMPs than other types of medicine. ATMP review times remain longer in the incoming clinical trial rules, although the survey suggests that is far from the biggest problem facing the industry. The data show review times vary across Europe, with authorities in Belgium and the United Kingdom typically signing off on studies within 60 days while their counterparts in France and Germany take six to 12 months.
Some of the long delays stem from national procedures for research involving genetically modified organisms (GMO). National agricultural or environmental agencies typically handle GMO reviews in the EU. ARM wants to see a consistent approach to GMO review taken across Europe and is calling for national authorities to add the capabilities they need to quickly process applications.
“It is important to ensure that ATMP clinical trials are approved in the shortest possible timeframes,” ARM wrote. “To effect this, national competent authorities must allocate sufficient resources and ensure an adequate level of expertise for the review of clinical trial applications for ATMPs.”
ARM Report
Swissmedic Details Plans to Align Combination Product Rules With EU
The Swiss Agency for Therapeutic Products (Swissmedic) has set out plans to align its approach to drug-device combination products with that of the EU. Swissmedic is set to make the changes to ensure regulatory harmonization after the EU brings in new rules covering medical devices.
EMA set out its planned approach to combination products in draft guidelines and a question and answer document earlier this year. While EMA is still finalizing those documents, Swissmedic vowed this week to align its approach to combination products with the specifications in development in the EU.
Swissmedic also intends to change its authorization requirements for combination products in light of the incoming EU rules, which require the device component to either have a CE mark or satisfy criteria set out in an annex to the legislation.
As part of the changes, Swissmedic plans to tailor its application forms to the new requirements. The agency is also set to publish revised guidance by the time the EU rules come into force in May.
Swissmedic Notice
Dutch MEB Seeks Feedback on Changes to Drug Labeling and Naming Rules
The Dutch Medicines Evaluation Board (MEB) has released planned changes to its drug labeling and naming rules for consultation.
MEB highlighted several key changes affecting each set of rules. The changes to the rules on labeling include plans to only permit multilingual packaging involving nations outside the European Economic Area if the product information is the same and complies with certain EU legislation. MEB also plans to modify its rules on the layout of labels, including through the addition of a section on safety features.
Planned changes to the rules on drug naming include the prohibition of names that make direct or indirect references to scientists or healthcare professionals. MEB has also clarified how to separate the names and doses of ingredients contained in combination products.
The Dutch regulator wants to relax other aspects of the naming rules. Notably, MEB will lift its ban on the use of product names that do not differ from the name of the marketing authorization holder by more than three letters. 
MEB is accepting feedback on the proposals until 13 December. 
MEB Notice (Dutch)
Finland set to Move to Electronic Submission of Annual Trial Safety Reports
The Finnish Medicines Agency (Fimea) is set to accept annual safety reports from clinical trials via an online portal from 18 November. Fimea will use the Common European Submission Portal (CESP) to receive the reports electronically.
Fimea has traditionally been one of the national competent authorities that makes limited use of the EU-wide CESP as a way to receive filings related to clinical trials. That is changing, starting with the imminent acceptance of development safety update reports (DSURs) via the Heads of Medicines Agencies’ (HMA) online portal.
In updating its listing on the HMA CESP website with news of the new DSUR policy, Fimea also said it will start accepting other clinical trial submissions through the portal later in 2019.
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) is the only other regulator listed on the HMA website that refers specifically to its policy on accepting PSURs through CESP. The German agency only receives DSURs and other clinical trial submissions “using BfArM accepted ways.”
Fimea Notice
PRAC Recommends Restrictions on use of Sanofi’s MS Drug Lemtrada
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended placing restrictions on the use of Lemtrada, Sanofi’s treatment for relapsing remitting multiple sclerosis. PRAC wants use of Lemtrada to be limited to adults whose disease is active despite treatment with other drugs.
The proposal would restrict Lemtrada to two groups: patients who have highly active disease despite receiving one or more disease-modifying therapies and people who suffer at least two disabling relapses a year and have brain images showing new damage. PRAC wants to impose the restrictions on an interim basis while it completes its review.
The review and PRAC’s initial recommendations were triggered by reports that patients suffered serious heart, circulation and bleeding disorders and developed autoimmune conditions after taking the drug. Some of the adverse events resulted in death.
PRAC made the recommendations at a meeting where it also called for a more cautious approach to the use of Pfizer’s JAK inhibitor Xeljanz. The committee wants physicians to use the drug cautiously in patients at high risk of blood clots. That advice reflects evidence that Xeljanz may increase the risk of blood clots in the lungs and deep veins of some patients.
PRAC Notice


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.