Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Industry Finds Fault With UK Vision for Drug Regulation After Brexit
British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The trade groups found fault with proposals for how the Medicines and Healthcare products Regulatory Agency (MHRA) will handle orphan drugs, regulatory fees, the Falsified Medicines Directive and other issues if Britain crashes out of the European Union.
MHRA spent last month gathering feedback on proposals for how the United Kingdom should adapt its drug regulations and legislation to mitigate the impact of it exiting the EU without a deal in March. The consultation sought to gauge industry views on MHRA’s handling of key questions posed by the prospect of a no-deal Brexit.
Joint feedback from the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) suggests MHRA is some way from coming up with a set of changes that satisfy drug developers and manufacturers. ABPI and BIA agreed with with many of the proposals, in some cases with notable caveats, but also found fault with MHRA’s response to some of the biggest issues facing the agency and the companies it regulates.
Points of disagreement between MHRA and the trade groups include how to convert the licenses for products authorized at the EU level into authorizations that are valid in the UK after Brexit. MHRA is proposing to automatically convert centrally authorized products to UK marketing authorizations the day Britain leaves the EU. The agency would not charge a fee for the conversion.
ABPI and BIA did not voice criticisms of these aspects of the conversion process. However, the trade groups spoke out strongly against the data requirements for products that undergo the conversion. MHRA is proposing to make marketing authorization holders (MAHs) submit baseline data on their products within one year of Brexit. The agency will not accept variation notifications until it receives baseline data.
The data requirements have not gone down well with the industry. ABPI and BIA want MHRA to eliminate the requirement for MAHs to file baseline data and urged the agency to look into getting the information from the European Medicines Agency (EMA) instead.
“The compiling of baselines is a time-consuming and labour-intensive process which impacts MAHs’ staff administrative costs, and will be challenging, if not impossible, for companies to complete for all concerned products in the time available. The high volume of baseline submissions required around Exit day will also likely place a strain on MHRA systems and resources,” the trade groups wrote.
In the event baseline data is needed, the trade groups want MHRA to reconsider its timelines. While welcoming the one-year transition in theory, ABPI and BIA said that in practice companies will need to submit baseline data far sooner to enable them to file variation notifications.
Other ABPI and BIA criticisms of MHRA’s proposals shed light on the difficulty of separating entwined regulatory systems. For example, the trade groups are worried that the revocation of the Falsified Medicines Directive by the UK could “introduce a security risk to all other national systems.” The trade groups wants the UK to make “consequential commitments” that security will not be harmed.
These concerns will only come into play if the UK leaves the EU without a deal. That could happen if the UK and EU are unable to reach an agreement in time, or if the deal they strike is voted down by the British parliament.
EU Medical Device Coordination Group Calls for Observers to Join
The Medical Device Coordination Group (MDCG) is seeking the input of experts in eight fields to help it support the harmonized implementation of incoming regulations. MDCG was set up a year ago to assist the European Commission and member states with the implementation of rules on medical devices and in-vitro
In light of the technical nature of its work, MDCG wants stakeholder associations to put forward people well-versed in standards, unique device identification, IVDs and other matters. Successful applicants will serve as observers to MDCG working groups for an initial period of five years, meaning their involvement will extend beyond the 2020 and 2022 implementation dates for the regulations.
The observers will support eight of the 10 working groups created by MDCG. The coordination group did not request applicants to support its working groups on market surveillance and notified bodies oversight.
MDCG is accepting applications until 15 November.
Swissmedic Finds Sartans on Sale in Switzerland are Free of NDMA
The Swiss Agency for Therapeutic Products (Swissmedic) has found none of the sartans on sale in its jurisdiction are contaminated with N-nitrosodimethylamine (NDMA). Swissmedic conducted tests on the whole sartan class in response to the contamination of batches of valsartan.
The discovery of carcinogen NDMA in batches of valsartan made by Zhejiang Huahai Pharmaceutical led to recalls around the world earlier this year. Swissmedic responded by testing valsartan products sold in Switzerland. Those tests, the findings of which were reported in August, found no evidence of contamination, prompting Swissmedic to extend its analysis to other types of sartan.
Like valsartan, losartan, olmesartan, candesartan and irbesartan feature a tetrazole ring that renders them vulnerable to contamination with NDMA. Swissmedic tested more than 50 drugs that contain sartans other than valsartan and found no evidence of contamination.
While the lack of NDMA contamination in products containing valsartan and other sartans is positive news, Swissmedic is continuing to subject the class of medicines to additional analytical monitoring. Swissmedic thinks vigilance is needed in light of the discovery of another contaminant in sartans.
, Analytical Results
Netherlands Bans OTC Sales of Inhibin in Light of Heart Risk Data
The Dutch Medicines Evaluation Board (MEB) has banned over-the-counter (OTC) sales of Inhibin. MEB made the medicine prescription only after assessing studies linking a related drug to an increased risk of serious cardiac arrhythmias.
Inhibin, which contains the active ingredient hydroquinine hydrobromide, is used in the Netherlands to treat nocturnal cramps and has been available OTC in the country since 1990. However, two studies linking products that contain quinine to increased risk of cardiovascular events and death have led MEB to change its position.
MEB did not cite the studies that underpinned its decision, but the data it referred to suggests some of the evidence came from research published in JAMA
last year. The researchers analyzed data on 12 million people in the UK. The death rate among people who took quinine was 4.2 per 100 person years, compared to 3.2 in the control cohort.
The study looked at the effect of quinine, not hydroquinine, but MEB thinks the ingredients may both raise the risk of cardiac arrhythmias as they otherwise have similar effects on the body. In light of the perceived risk, MEB is making Inhibin a pharmacy-only medicine and advising people who suffer from cardiac arrhythmias to take particular care.
government has said it will not build cold-chain storage facilities to mitigate the shortage of capacity created by the need to stockpile products ahead of Brexit
. The government is going ahead with a previously reported tendering process to identify third parties that can bring additional space online. Written Answer