Regulatory Focus™ > News Articles > 2021 > 10 > Euro Roundup: PRAC starts reviewing risk of tumors linked to women’s health products

Euro Roundup: PRAC starts reviewing risk of tumors linked to women’s health products

Posted 07 October 2021 | By Nick Paul Taylor 

Euro Roundup: PRAC starts reviewing risk of tumors linked to women’s health products

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started reviewing the risk of tumors linked to women’s health products that contain nomegestrol or chlormadinone. PRAC opened the review in response to cases of non-malignant tumors of the brain and spinal cord.
Nomegestrol or chlormadinone are used in products that treat gynecological disorders, such as uterine bleeding, and as hormone replacement therapies or contraceptives. One product, Theramex’s birth control pill Zoely, is centrally authorized but the rest of the medicines covered by the review were cleared for use by national regulators.
The French National Agency for Medicines and Health Products Safety (ANSM) triggered the review by presenting data from two epidemiological studies that suggest the risk of the tumors increases with the dose and duration of treatment. Women who take the medicines for several years may be at higher risk. The risk then appears to fall away after women stop taking the medicines for a year.
Some nomegestrol and chlormadinone products already carry warnings about the tumor risk. The ANSM results are new, though, prompting PRAC to start reviewing the overall evidence to inform any potential actions by EMA.
EMA Notice, More
Ireland’s HPRA proposes fee freeze ahead of ‘very challenging’ 2022
Ireland’s Health Products Regulatory Authority (HPRA) has proposed freezing its fees the second year running despite warnings that factors such as Brexit, COVID-19 and the implementation of three new regulations will make 2022 “very challenging.”
Under any circumstances, 2022 would be a busy year for European regulators. As HPRA explained, next year is unique in that it will be implementing three new regulations on veterinary medicines, clinical trials and in vitro diagnostics (IVDs). The three new regulations will arrive at a time when HPRA is still implementing the Medical Device Regulation, which took effect in May.
“These new Regulations place very explicit obligations on regulatory authorities in relation to their activities, resources and capabilities. In addition, growth in specific technological areas, such as digital health products and in-vitro diagnostics will necessitate reallocation, repurposing and development of our staff,” HPRA wrote.
The Irish regulatory agency expects the new regulations to impact departments across its operation, with management, legal, HR, IT and financial support needing to step up to help the veterinary, clinical trial and IVD teams to successfully deliver the legislation.
HPRA will need to implement the regulations while managing the fallout of Brexit and COVID-19. The acute phase of both situations may now have passed, with Brexit now being a reality — and bringing an influx of economic operators to Ireland — and vaccines getting the pandemic under control. Yet, HPRA will continue to feel the consequences of Brexit and COVID-19 next year.
Starting in January, HPRA expects staff to return to work on a “hybrid basis,” rather than working from home full time. HPRA warned the return to the office will “significantly” increase costs. The impact of the change will be magnified by the growth of the workforce. HPRA hired more staff to address the COVID-19 crisis and plans to retain the new staff in the expectation that the virus will be the source of “considerable activity” in 2022, even if the pandemic ends.
HPRA plans to cover the additional costs anticipated for 2022 without raising its fees. The proposal reflects the fact HPRA ran a surplus in 2020 and 2021. HPRA plans to create two new compliance fees, hold a separate consultation on its fees for the clinical trial regulations and reduce its fees for some medical device activities.
The regulator, which also published a consultation on its veterinary fees, is accepting feedback until 29 October.
HPRA Consultation, More
Dutch MEB rolls out changes to drug shortage and defect notifications
The Dutch Medicines Evaluation Board (MEB) is implementing changes to the drug shortage and defect notification process. Starting on Friday, MEB will switch to a revised notification form that is designed to be more user-friendly.
MEB has deleted some questions from the existing form, such as about the company’s address, and has amended other queries to make them more specific. The amended questions are intended to improve the information MEB gathers on market share and the availability of alternative medicines. MEB has also added some questions and changed the message confirming receipt.
The new form will become available at the end of the working day, Dutch time, on Friday 8 October. MEB is asking the industry not to submit notifications of shortages on 7 or 8 October. Authorities will take the inability to submit notifications on those days into account in their supervisory tasks. The form will remain available to companies that need to submit urgent notifications on both days.
MEB wants companies with incomplete notifications to finish the process before 8 October. However, MEB is giving companies that are unable to hit that deadline until 5 November to complete their filings.
MEB Notice
EU imposes new requirements on medical devices that contain cobalt
New restrictions on the inclusion of cobalt in medical devices have come into force in the EU. From 1 October, manufacturers must justify their use of cobalt, for example by explaining why it cannot be replaced by another material, and indicate its presence on the medical device labeling.
Concerns about the use of cobalt in metal-on-metal bearing joint replacements led the EU to include provisions related to the material in the Medical Device Regulation. The new rules treat cobalt as a carcinogenic substance but fall short of an outright ban on the use of the metal, choosing instead to try to mitigate the risks.
As France’s ANSM explained in a notice, manufacturers of products that contain more than 0.1% cobalt must meet new safety and performance requirements, justify their use of the metal and provide notices about the residual risks. ANSM has created a question-and-answer document to address any queries raised by the new requirements.  
ANSM Notice (French)
EMA backs use of extra doses of COVID-19 vaccines and booster shots
EMA has ruled third doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines may be given in some circumstances. The ruling differentiates between “extra doses” for people with severely weakened immune systems and “boosters” for the broader adult population.
In people with severely weakened immune systems, EMA ruled an extra dose of Comirnaty or Spikevax may be given starting 28 days after the administration of the second shot of the vaccine. The advice is based on evidence that a third dose enables people with weakened immune systems to make more antibodies, although the effect on protection against COVID-19 is unproven.
EMA’s second ruling covers the use of booster doses in adults with normal immune systems. The data led EMA to conclude boosters may be considered at least six months after the second dose in people aged 18 years and older. The decision on whether to give boosters is a national matter. EMA is carefully monitoring the risk of inflammatory heart conditions linked to booster shots.
EMA Notice
Other News:
The All Wales Therapeutics and Toxicology Centre (AWTTC) has joined the British Innovative Licensing and Access Pathway (ILAP). AWTTC’s involvement means groups that handle health technology appraisal in England, Scotland and Wales, the three parts of Great Britain, are now part of ILAP. MHRA Notice


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.