Euro Roundup: EMA starts phasing out regulatory flexibilities provided during COVID-19 pandemic

The European Medicines Agency (EMA) has begun phasing out the regulatory flexibilities it offered the pharma industry to offset the impact of the COVID-19 pandemic.

As COVID-19 disrupted the pharma industry and its own operations, EMA offered regulatory flexibilities related to areas including marketing authorization, manufacturing, imports, quality variations, labeling, packaging and compliance. A series of measures aimed to mitigate the impact of the pandemic on facility inspections and ensure the continued availability of medicines from sites that met good practices.

Many of the problems that prompted EMA to temporarily revise its rules are no longer relevant. In May, the World Health Organization declared the end of the COVID-19 public health emergency and in-person activities and travel have resumed.

In response, EMA has said flexibilities introduced “specifically during the COVID-19 pandemic should no longer be granted.” EMA is gradually phasing out the flexibilities it has already provided to minimize the impact of the changes. For example, EMA will continue to allow the English-only labeling of COVID-19 vaccines until the end of the year to avoid the supply disruption that could result from a sudden change.

Similarly, EMA’s plans to switch to a routine approach to inspections and good practice certificates are complicated by the lingering aftereffects of the pandemic. EMA and its collaborators are performing on-site inspections but still have to work through the backlog of assessments that built up when they were forced to postpone visits or evaluate sites virtually because of COVID-19.

Because of the backlog, EMA has extended the validity of good manufacturing and distribution practice certificates until the end of the year. The GMDP Inspectors Working Group is set to share details of the approach for 2024 in the coming months and having reviewed the remote working of Qualified Persons during the pandemic, plans to issue guidance on how those arrangements can be applied in the future.

EMA Notice

Reports of suicidal thoughts and self-injury trigger EMA review of GLP-1 agonists

EMA said it is reviewing the safety of GLP-1 receptor agonists after receiving reports linking some molecules in the class of diabetes and weight loss medicines to suicidal thoughts and self-injury.

The Icelandic Medicines Agency triggered the review after receiving reports of the adverse events in people taking liraglutide and semaglutide medicines. Patients have collectively taken liraglutide, the active ingredient in Saxenda, and semaglutide, which is found in Ozempic, Wegovy and Rybelsus, for more than a combined 20 million years.

Authorities are analyzing about 150 possible cases of suicidal thoughts and self-injury. It is unclear if the cases are linked to the medicines or reflect the underlying condition of the patients or other factors. The signal procedure initiated by EMA will try to establish whether the medicines played a causal role.

EMA initially focused the review on liraglutide and semaglutide, molecules sold by Novo Nordisk for weight management and the treatment of type 2 diabetes. However, the agency quickly expanded the investigation to cover other GLP-1 receptor agonists. The expanded review will also review the data on AstraZeneca’s Byetta (exenatide), Eli Lilly’s Trulicity (dulaglutide) and Sanofi’s Lyxumia (lixisenatide).

Physicians have used GLP-1 receptor agonists to treat type 2 diabetes for more than 15 years but interest in the class has taken off more recently as clinical data on the effect of semaglutide and Lilly’s tirzepatide on obesity have shown the medicines can support significant weight loss.

EMA Notice

EFPIA voices ‘disappointment’ over IP elements of EU-New Zealand free trade deal

EFPIA has expressed “disappointment” over the failure of a European Union free trade agreement (FTA) to secure improved intellectual property (IP) provisions in New Zealand.

This week, the EU and New Zealand signed an FTA that will cut duties and is forecast to increase bilateral trade between the two sides by 30% over the next 10 years. The EU has focused on the potential for the deal to increase agri-food exports and protect regional products, while also hailing the FTA as having the most ambitious sustainability commitments in a trade agreement.

However, the pharma industry wanted more from the agreement. After the FTA was signed, big pharma trade group voiced disappointment over the lack of IP provisions. The focus reflects EFPIA’s view that New Zealand has “one of the weakest IP regimes” of the Organisation for Economic Co-operation and Development countries. EFPIA is calling for New Zealand to bring its IP regime in line with that of the EU.

“We remain hopeful that the two sides will establish alternative platforms and dialogues where further discussions can take place to continue the work to bring the two IP regimes to the same level to the benefit of patients, who can then have faster access [to] innovative treatments,” EFPIA wrote.

EFPIA Statement, Press Release

Swissmedic issues warning after falsified Ozempic pens hospitalize patients

Swissmedic has warned against buying Ozempic online. The warning follows reports that people were hospitalized after using falsified Ozempic.

Demand for Ozempic and its sister medicine Wegovy has increased as Novo Nordisk has shown the GLP-1 receptor agonists can support weight loss. The effect of the molecules on body weight, which has been widely discussed in mainstream and social media, has driven increased demand, and caused supply shortages. Novo Nordisk is addressing the shortages, but supply of some products remains constrained.

The situation has created an opportunity for suppliers of falsified medicines. Swissmedic has received reports that people have been hospitalized after buying Ozempic from “unreliable sources.” The agency is concerned about people buying the medicine online and from retailers based overseas.

In some cases, people have been hospitalized after taking falsified Ozempic obtained outside of the legal Swiss distribution chain. The patients suffered from low blood sugar, also known as acute hypoglycemia. Low blood sugar is a known side effect of Ozempic but in one case the patient was found to have bought an insulin pen sold in Ozempic packaging. Insulin overdoses can cause life-threatening hypoglycemia.

Swissmedic Notice

MHRA shares strategy for attracting, developing and retaining talent in coming years

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its people strategy for the next three years, setting out how it plans to attract, develop and retain regulatory talent.

MHRA made “enabling people to flourish” one of the core goals of its corporate plan for 2023 to 2026. In a follow-up document, the agency provided more information about how it will achieve that goal. The people plan calls for MHRA to simplify recruitment systems, increase apprenticeships, improve training and identify barriers to equity of opportunity by March 2024.

The activities are intended to help MHRA hit a set of targets. MHRA is aiming to reduce its vacancy rate from 19.7% to 11% and cut the time to hire from 35 days to 25 days. Other goals include reducing its rate of annualized voluntary turnover from 16.5% to the 11% to 13% range, and to improve the retention of permanent new hires from an estimated 70% to at least 80% after three years.

MHRA will work to hit those targets while trying to diversify its workforce, in terms of ethnicity, disability and sexual orientation, and reduce sickness absence rates and bullying, harassment and discrimination scores.

MHRA Strategy

Euro Roundup: EMA starts phasing out regulatory flexibilities provided during COVID-19 pandemic

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