Euro Roundup: Commission seeks feedback on pharmaceutical legislation reform

RoundupsRoundups | 30 September 2021 |  By 

The European Commission is seeking feedback on planned reforms intended to address problems such as the “inefficiency and administrative burden of regulatory procedures.”
It’s been 20 years since the European Union held its last comprehensive review of general pharmaceutical legislation. The consultation, which grew out of a strategy adopted late last year, is part of a push to reform pharmaceutical legislation in light of changes to society and science and lessons learned since the last major round of revisions.
The Commission has identified a series of problems it wants to solve. As well as the aforementioned regulatory burdens, the Commission is aiming to tackle unequal access to affordable medicines, drug shortages, the inability of the framework to respond quickly to innovation and other problems.
In the consultation, the Commission asks if there are other problems it needs to address and tasks respondents with ranking how the current legislation has performed against various metrics. The rest of the consultation looks forward to solutions the EU could implement to address the shortcomings of the current framework.
The Commission is seeking feedback on topics including the need to reform manufacturing rules. The survey asks respondents to say whether they want to see the current rules maintained, strengthened or modified, for example through the inclusion of “selected environmental requirements” in line with the “one health approach on antimicrobial resistance.”
Another section poses a similar question about how to ensure the security of supply of medicines. The options put to respondents in that section include making companies have shortage prevention plans, safety stocks or more diverse supply chains. The Commission is also seeking views on the need for an EU-level system for monitoring shortages.
Other parts of the consultation cover questions such as whether the Commission should authorize generics and biosimilars despite ongoing patent protection, require companies to make their medicines available in most member states, or create “adaptive regulatory frameworks...for certain novel types of medicines or low volume products.”
The Commission is accepting feedback until 21 December.
Press Release, Consultation Document
EDQM identifies another azido impurity in sartans, advances review of fixes
The European Directorate for the Quality of Medicines (EDQM) has identified another azido impurity. So far, the new impurity, which tested positive in a mutagenicity evaluation, has only been found in losartan potassium.
EDQM disclosed information about potentially mutagenic azido impurities in certain sartan active substances in April. Since then, EDQM has worked with manufacturers to assess the problem and keep impurities below acceptable levels, leading to the identification of a new azido in some sources of losartan, the active ingredient in blood pressure drugs such as Organon’s Cozaar.
The sources impacted by the impurity are now known, EDQM said, and the directorate’s reviews of the corrective actions taken by companies are well advanced or complete. EDQM lacks information from in vivo studies, leading it to propose keeping the impurity below the Threshold of Toxicological Concern.
Work to keep the levels of the new azido below the threshold forms part of a broader effect to stop the impurities from impacting human health. EDQM said it is nearing the end of its review of all the corrective actions taken to control azido levels and reminded Certificate of Suitability holders to share “appropriate information” about the impurities with marketing authorization holders. 
EDQM Notice
ABPI calls for UK government to ‘mandate rapid timelines’ for clinical trial approvals
The Association of the British Pharmaceutical Industry (ABPI) has called on the UK government to use the lessons of the COVID-19 crisis to revitalize the post-pandemic clinical research environment.
Regulators, industry and other stakeholders moved quickly during the pandemic to set up and finish clinical trials of COVID-19 vaccines and treatments in record time. However, while the UK made big contributions to COVID-19 research, ABPI has found enrollment in non-coronavirus studies fell more than in other countries and remains at a lower level.
In response, ABPI wants the government to take actions including reforming the approval and setup of clinical trials. Specifically, the trade group is calling for lawmakers to “use the Medicines and Medical Devices Act 2021 to mandate rapid timelines for regulatory approvals” and “ensure costing and contracting processes being made quicker, more transparent and less variable.”
The request comes at a time when the UK Medicines and Healthcare products Regulatory Agency (MHRA) is facing budget pressures. ABPI wants the government to ensure MHRA and the UK Health Research Authority “are properly resourced” when it conducts an upcoming spending review.
ABPI Report
MHRA shares guidance on need to review registration of medical devices
MHRA has told medical device manufacturers to review their registration information “frequently” to ensure it is up to date. The agency provided the advice in an update to its guidance on registering medical devices.
Companies are legally required to tell MHRA about any changes in their registrations. MHRA has set up an “update registered devices and products functionality” companies can use to update data fields that were not previously populated. MHRA is urging companies to use the function to add UDI-DIs given their importance for patient safety. There is no fee for using the function.
MHRA has implemented a review reminder system but has asked companies not to wait for email prompts before reviewing their information. The first reminder date is one year after account creation. From then on, reminders will happen at least every two years. MHRA will send automated email reminders three, two and one months before the renewal date.
MHRA Guidance
EMA starts evaluating booster shot of Moderna’s COVID-19 vaccine
EMA has started evaluating data on booster doses of Moderna’s Spikevax COVID-19 vaccine. The application covers the use of a booster shot at least six months after the second dose in people aged 12 years and older.
The initiation of the review comes weeks after EMA began assessing the use of the Pfizer-BioNTech vaccine as a booster and against a backdrop of doubts about the need for most people to receive a third dose so soon after completing the original regimen.
Earlier this month, the European Centre for Disease Prevention and Control found there is “no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population.” Individual member states have already outlined plans to give third doses to higher-risk groups of patients.
EMA Notice
MHRA posts update on data integrity as OECD advice takes effect
The recently published OECD Advisory Document on Data Integrity takes precedence over existing MHRA guidance on the topic, the UK regulatory agency said.
MHRA created Guidance on GxP Data Integrity in 2018. That guidance is still available but, as the UK is a member of the OECD Mutual Acceptance of Data System, it is subordinate to the advisory from the intergovernmental economic organization. MHRA set out the implications of the change for good laboratory practice (GLP) facilities.
“The MHRA GXP Data Integrity Guidance was always intended to sit alongside additional regulatory guidance and should also continue to be used to supplement and support UK GLP facilities as it provides additional guidance primarily associated with the importance of a supportive organizational culture in order to embed and foster a strong data integrity culture within organizations,” MHRA said.
MHRA Notice


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