Euro Roundup: Commission seeks comments on reform of pharmaceutical law

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The European Commission is seeking comments on planned reforms aimed at addressing issues such as “the inefficiency and administrative burden of regulatory procedures”.

It has been 20 years since the European Union carried out its last comprehensive review of general pharmaceutical legislation. The consultation, which was born from a strategy adopted at the end of last year, is part of a campaign to reform pharmaceutical legislation in the light of changes in society and science and the lessons learned since the last major round of revisions.

The Commission has identified a series of problems that it wishes to resolve. In addition to the aforementioned regulatory burdens, the Commission aims to tackle unequal access to affordable medicines, drug shortages, the executive’s inability to respond quickly to innovation and other issues.

During the consultation, the Commission asks if there are any other issues it needs to resolve and instructs respondents to rank the performance of current legislation against various parameters. The remainder of the consultation looks forward to the solutions that the EU could implement to address the shortcomings of the current framework.

The Commission is seeking comments on topics such as the need to reform manufacturing rules. The survey asks respondents whether they wish to see the current rules maintained, strengthened or changed, for example by including “selected environmental requirements” in line with the “one health approach to antimicrobial resistance”.

Another section asks a similar question on how to ensure security of drug supply. Options offered to respondents in this section include ensuring that companies have shortage prevention plans, safety stocks, or more diverse supply chains. The Commission is also seeking opinions on the need for an EU-level system to monitor shortages.

Other parts of the consultation cover issues such as whether the Commission should authorize generics and biosimilars despite pending patent protection, require companies to make their medicines available in most Member States, or create “adaptive regulatory frameworks … for certain new types of drugs or low volume products.”

The Commission accepts comments until December 21.

Press release, Consultation document

EDQM Identifies Another Azido Impurity in Sartans and Advances Patch Review

The European Directorate for the Quality of Medicines (EDQM) has identified another azido impurity. So far, the new impurity, which was found to be positive in an assessment for mutagenicity, has only been found in losartan potassium.

The EDQM disclosed in April information on potentially mutagenic azido impurities in certain active substances in sartan. Since then, the 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 antihypertensive drugs such as the Cozaar d’Organon.

The sources impacted by the impurity are now known, the EDQM said, and management reviews of the corrective actions taken by the companies are well advanced or completed. The EDQM lacks information from in vivo studies, leading it to propose to keep the impurity below the threshold of toxicological concern.

Efforts to keep the levels of the new azido below threshold are part of a larger effect aimed at preventing impurities from impacting human health. The EDQM said it was nearing the end of its review of all corrective actions taken to control azido levels and reminded holders of certificates of compliance to share “appropriate information” on impurities with holders. marketing authorizations.

EDQM opinion

ABPI calls on UK government to ‘impose rapid deadlines’ on clinical trial approvals

The Association of the British Pharmaceutical Industry (ABPI) called on the British government to learn from 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 complete clinical trials of COVID-19 vaccines and treatments in record time. However, while the UK has made great contributions to COVID-19 research, the ABPI has found that enrollments in studies unrelated to the coronavirus have fallen more than in other countries and remain at a low. lower level.

In response, ABPI wants the government to take action, including reforming the approval and implementation of clinical trials. Specifically, the trade group calls on lawmakers to “use the Drugs and Medical Devices Act 2021 to impose swift deadlines for regulatory approvals” and “ensure that the costing and contracting processes are faster, more transparent and less variable ”.

The request comes at a time when the UK Medicines and Health Products Regulatory Agency (MHRA) is facing budget pressures. The ABPI wants the government to ensure that the MHRA and the UK Health Research Authority “have sufficient resources” when they conduct an upcoming spending review.

ABPI report

MHRA shares advice on need to review medical device registration

The MHRA has asked medical device manufacturers to review their registration information “frequently” to ensure it is up to date. The agency provided this guidance in an update to its guidelines on medical device registration.

Companies are legally required to notify the MHRA of any changes in their registrations. The MHRA has implemented a “feature update for registered devices and products” that businesses can use to update data fields that were not previously populated. The MHRA urges companies to use the feature to add IDU-IDs given their importance to patient safety. Use of the function is free.

The MHRA has implemented a review reminder system, but has asked companies not to wait for email prompts before reviewing their information. The first recall date is one year after the creation of the account. From then on, recalls will take place at least every two years. The MHRA will send automatic email reminders three, two, and one month prior to the renewal date.

MHRA Guidelines

EMA begins evaluating Moderna’s COVID-19 vaccine booster

The EMA has started evaluating data on booster doses of Moderna’s Spikevax COVID-19 vaccine. The request covers the use of a booster at least six months after the second dose in persons 12 years of age and older.

The launch of the review comes weeks after the EMA began evaluating the use of the Pfizer-BioNTech vaccine as a booster and amid doubts that most people need to receive a third dose so little. long after completing the original diet.

Earlier this month, the European Center for Disease Prevention and Control find there is “no urgent need to administer booster doses of vaccines to fully vaccinated individuals in the general population”. Some Member States already have describe plans to give third doses to high-risk patient groups.

EMA opinion

MHRA issues update on data integrity as OECD guidance takes effect

The recently published The OECD advisory document on data integrity takes precedence over existing MHRA guidelines on the subject, the UK regulator said.

The MHRA created a GxP Data Integrity Guide in 2018. This guide is still available but, as the UK is a member of the OECD Mutual Data Acceptance System, it is subordinate to the Council of the intergovernmental economic organization. The MHRA outlined the implications of the change for Good Laboratory Practice (GLP) facilities.

“The MHRA GXP Data Integrity Guide has always been designed to accompany additional regulatory guidance and should also continue to be used to complement and support UK BPL installations, as it provides additional guidance primarily associated with the ‘The importance of a supportive organizational culture in order to embed and foster a strong culture of data integrity within organizations, ”said the MHRA.

MHRA Opinion

© 2021 Society of Regulatory Affairs Professionals.


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