European Regulatory Roundup: Swissmedic Backtracks on ‘Cumbersome’ New Requirements (7 January 2016)

Regulatory NewsRegulatory News | 07 January 2016 |  By 

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

Swissmedic Backtracks After Firms Find Changes “Cumbersome”

The Swiss Agency for Therapeutic Products (Swissmedic) has dropped a change it made at the end of October after admitting the new approach was “too cumbersome” for companies. Swissmedic made the original change as part of a suite of revisions to the process for variations requiring notification.

For the final two months of 2015, Swissmedic asked co-marketing authorization holders to submit a copy of the invoice it supplied when making variations requiring notification. However, the model, which replaced a requirement to give Swissmedic a copy of the approval letter when notifying it of variations, has caused problems for companies. Swissmedic has acted quickly to reverse the earlier decision.

“The practice introduced on 31 October 2015 ... has proved to be too cumbersome in practice for companies,” Swissmedic wrote in an update published on 1 January. Having identified the approach as problematic, Swissmedic has adopted another paperwork requirement, which is distinct from the ones in place both before and after the revision at the end of October. Swissmedic wants firms to send “a copy of the confirmation of receipt or a print-out of the relevant Swissmedic Portal entry.”

While the paperwork requirement for co-marketing authorization holders was the only aspect of the new process to be dropped completely, Swissmedic felt compelled to clarify other aspects of the changes. One of the clarifications relates to Swissmedic decisions on variation notifications. Starting from 1 January, Swissmedic will update the portal with “Approval” or “Refusal,” a move it thinks will speed up the process. Once a firm has an approval, it can implement the change immediately.

Swissmedic Notice

EMA Posts Clutch of Draft Clinical Trial Documents in Final Days of 2015

The European Medicines Agency (EMA) closed out 2015 by posting three draft documents about aspects of clinical trials. In the texts, EMA outlines its current thinking on the clinical development of interferon alpha, pain treatments and drugs being tested in elderly populations.

A draft guideline on the development of treatments for pain is the most advanced of the three texts, having already been through the public consultation process once. The first public consultation got underway in June 2013. Since then, the guideline has undergone a major overhaul. The latest version features eight pages that deal with specific requirements for the clinical development of treatments for different types of pain, such as those experienced during cancer or fibromyalgia.

The section, which forms the centerpiece of the latest guideline, was absent from the 2013 version, which dealt with different types of pain to an extent but spread the information across the text. By collecting and expanding on the information relating to different types of pain, EMA should have made it easier for drug developers to access the guidance that is of most relevance to its clinical trial programs. The comment period for the guideline closes at the end of March.

On the day EMA published the second draft of the pain guideline, it also released a concept paper on the development of biosimilars containing recombinant interferon alpha or pegylated recombinant interferon alpha. The text is intended to bring advice provided in a reflection paper in 2009 up to date. EMA also published a “points to consider” document on the use of tools to evaluate baseline characteristics of elderly trial participants, a population regulators want to see included in research.

Pain Treatment, Interferon Alpha, Frailty

UK Gives Merck’s Keytruda to 500 Patients Under Early Access Scheme

The United Kingdom has published data on the uptake of Merck’s immuno-oncology drug Keytruda under the recently introduced early access to medicines scheme (EAMS). Since becoming the first drug to be accepted into EAMS in March, Keytruda has been given to 500 patients in the UK.

Officials at the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and Merck are hailing the patient uptake data as evidence of the effectiveness of EAMS at cutting the time it takes for people with unmet medical needs to receive new treatments. MHRA thinks EAMS resulted in the drug, the scientific name of which is pembrolizumab, being made available to patients around four months sooner than would have been possible under the traditional pathway.

Such time savings can make a significant difference to the lives of patients, while also providing firms with a chance to start recouping a return on their investment in R&D sooner. “EAMS undoubtedly accelerated access to pembrolizumab for patients with advanced melanoma and demonstrates a world-leading example of how healthcare agencies and industry can work together to get treatments to patients more quickly,” Ben Lucas, oncology business unit director at Merck, said.

Other companies are now trying to replicate the success of Keytruda, which went from reporting Phase I data to being accepted into EAMS in nine months. Since accepting Keytruda into EAMS, MHRA has gone on to issue positive scientific opinions for AstraZeneca’s Tagrisso, Bristol-Myers Squibb’s Opdivo and Novartis’ Entresto. MHRA made the rulings about Tagrisso and Entresto before the Committee for Human Medical Products (CHMP) recommended their approval in Europe.  

MHRA Statement, Case Study

CHMP Adopts Guideline on Duchenne Muscular Dystrophy Clinical Trials

EMA’s CHMP has published its final guidance on the clinical development of drugs to treat Duchenne and Becker muscular dystrophy (DBMD). The text is intended to clarify the process for assessing the safety and efficacy of DBMD drugs, a class of products that have caused regulatory disputes.

Highly active DBMD patient groups have criticized regulators, notably the US Food and Drug Administration (FDA), for being slow to provide guidance, a situation that is seen by some as contributing to disputes with drug developers over endpoints and trial designs. FDA published draft guidance in June 2015, 18 months after a Duchenne muscular dystrophy (DMD) consortium began work on its own text. EMA got started on its guidelines before either organization.

Having agreed an initial draft in January 2013, EMA has now gone through the consultation process and emerged with a final text that will come into force at the start of July. The guideline covers the whole process of developing drugs for DBMD, a collection of rare genetic diseases that result in the progressive weakening of the muscles. Developers can turn to the guideline for advice on selecting patients, designing studies and assessing safety and efficacy.

The selection of endpoints and the size of DMD trials have proven to be contentious topics, with FDA and Sarepta Therapeutics disagreeing in the past about what constitutes data that is fit for filing. The EMA guideline goes some way to cutting the chances of such disagreements happening in Europe in the future, although the text falls short of being a blueprint for trials. “From a regulatory point of view, no specific recommendation for the choice of measurement tools can be made,” EMA wrote.     

Final Guideline

Other News:

EMA has released its final guideline on the clinical development of treatments for amyotrophic lateral sclerosis (ALS). The text, which will come into effect on 1 June, sets out a general strategy for the development of treatments for ALS, before digging into the decisions that need to be made when setting inclusion/exclusion criteria and establishing efficacy endpoints. EMA Guideline

Swissmedic has changed its requirements for companies that submit paper-based authorization applications. Up to 1 January, the Swiss regulator asked companies to file two copies of their paper application. However, having identified a dwindling of the need for hard copies, Swissmedic will now accept submissions that include just one set of the documents. Swissmedic Notice 


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