EU Regulatory Roundup: Regulators propose 40 actions to cut risk of medicine impurities

RoundupsRoundups | 25 June 2020 | By

European regulators have used their experience with the sartan contamination crisis to draw up a list of 40 recommendations for how to stop impurities from making their way into finished medicines.
Last year, members of the European regulatory network began considering the lessons learned from the discovery of N-nitrosamines in sartans and other classes of medicines. After receiving pushback from industry late last year, they have published a list of 40 recommendations for mitigating the risk of impurities.
The advice covers the need to clarify the legal responsibilities of stakeholders including marketing authorization holders and manufacturers, the importance of batch-specific supply chain traceability between ingredients and finished products, and the value of expanded international collaboration.
The agencies call for the creation of a risk-based model for triggering preapproval inspections of active pharmaceutical ingredient manufacturers, and for the mandating of the inclusion of data on impurities in dossiers submitted by marketing authorization holders.
Having put forward the recommendations, European regulators now plan to consider what actions to implement to protect medicines from N-nitrosamines and other impurities. The recommendations will also inform existing initiatives, including an effort to provide guidance to manufacturers.
Implementation of the four recommendations related to international cooperation, plus some of the other positions, will require the involvement of regulators based outside of Europe. The agencies behind the document plan to bring those recommendations up at “the appropriate forums.”
Recommendations, Comments
UK government gains power to intervene in M&A on public health grounds
The UK government has adopted legislation to gain the power to intervene in takeovers that could weaken the country’s ability to combat public health emergencies.
Existing UK law supported interventions in takeovers affecting issues including the diversity of views expressed in media and the stability of the financial system. With the COVID-19 pandemic revealing the value of having strong domestic medical and R&D capabilities, the UK government has followed its Japanese counterpart in expanding the law to cover companies relevant to public health crises.
The amendment inserts “the capability to combat, and to mitigate the effects of, public health emergencies” into a list of public interest considerations that inform interventions in takeovers.
In a statement to explain the amendments, the government said the proposed powers would enable it to intervene if a vaccine developer, personal protective equipment manufacturer or other business directly involved in a pandemic response became a takeover target. The government also sees the law as a way to fend off opportunistic offers for companies weakened by a pandemic.
The government used a legislative mechanism to rapidly adopt the changes, which were disclosed on 21 June and came into force on 23 June. Under the old law, the UK intervened in takeovers 20 times, although it has never blocked an acquisition on public interest grounds.
Draft Amendments, Press Release
Spain permits continued enrollment in some hydroxychloroquine trials
The Spanish Agency of Medicines and Medical Devices (AEMPS) has permitted the continuation of clinical trials of the use of hydroxychloroquine in certain COVID-19 populations.
Sponsors assessing the pre-exposure prophylactic use of hydroxychloroquine and its effectiveness in patients with mild cases of COVID-19 can continue their studies. AEMPS wants to see more data on the use of the drug in those settings and thinks the characteristics of the trials and patients enrolled in them supports ongoing testing.
Nine of the hydroxychloroquine COVID-19 trials authorized by AEMPS are testing the ability of the drug to prevent the disease. Another six studies are assessing hydroxychloroquine in patients with mild COVID-19, meaning 15 of the 20 clinical trials underway in Spain can continue.
The remaining five clinical trials are testing hydroxychloroquine in hospitalized patients. Having seen the interim analyses of trials conducted elsewhere, AEMPS is stopping enrollment in those trials. The agency is open to allowing the resumption of enrollment if sponsors can share data linking the drug to clinical benefits, something that other studies have so far failed to find.
AEMPS is also placing restrictions on new studies. Sponsors that want to start studies need to show their patient population differs from that enrolled in failed international clinical trials. AEMPS wants sponsors targeting patient populations covered by ongoing studies in Spain to contribute to those trials, rather than start their own assessments.
AEMPS Notice
EMA creates new restrictions on competing interests of experts
The European Medicines Agency (EMA) has expanded restrictions on the competing interests of its scientific committee members and experts.
EMA has updated its policy on handling conflicts of interests several times since establishing the first version in 2004. The latest version, which is set to come into force on 1 January, creates new types of interest that affect the ability of members of EMA bodies such as Committee for Medicinal Products for Human Use to contribute to the agency’s work.
The new policy treats involvement in the repurposing of a medicinal product as a direct interest, the type of interest most likely to lead EMA to restrict the role of an expert. People involved in gathering evidence to support repurposing and in taking the project “up until the point of full engagement by a pharmaceutical company” will be affected by the EMA policy.
EMA is also adding new indirect interests. The revised policy treats experts whose organizations are involved in repurposing medicinal products as having indirect interests. EMA also treats experts who have family members with direct interests in pharmaceutical companies as having indirect interests.
Another section covers restrictions on competing interests specific to members of the Committee for Advanced Therapies (CAT). Those restrictions, which treat strategic advisory roles as direct interests, are based on the 2007 advanced therapy medicinal products regulations. While the general policy is limited to ties to the pharma industry, the CAT rules cover links to biotech and medtech.
Other changes include the addition of stock warrants to the definition of financial interests. EMA also revised its rules on the declared interests of its staff and job candidates.
EMA Rules, Outgoing Policy, More
MHRA frees COVID-19 test developers from form filling requirement
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has changed the process for registering a COVID-19 test kit.
Under the old requirements, companies needed to fill out a form to register a test kit with MHRA. Foreign manufacturers that wanted to place COVID-19 test kits on the UK market also needed to fill out a form.
MHRA dropped the form filling requirement from its guidance this week. Instead, MHRA now refers companies that want to register a COVID-19 test to another guidance document for manufacturers.
The agency made the changes in an update that introduced other small revisions. MHRA revised its statement about the status of CE-marked tests for home use to clarify it is only “currently” illegal to supply such products. MHRA also added a statement that distributors and suppliers cannot currently register with the agency.
MHRA Guidance
Other News:
The Dutch Medicines Evaluation Board (MEB) has shared details of how the COVID-19 pandemic is affecting the work of its veterinary medicinal product unit. MEB has extended good manufacturing practice inspection certificates until the end of next year. MEB Notice


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