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EU Regulatory Roundup: EMA seeks feedback on veterinary antimicrobial plan

Posted 02 July 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: EMA seeks feedback on veterinary antimicrobial plan

A proposed strategy document from the European Medicines Agency (EMA) would require post-authorization trials of veterinary antimicrobials to ensure the benefit-risk balance of a product remains positive, among other requirements. Such studies could cut the risk of the continued use of products that are driving the evolution of antibiotic-resistant bacteria.
The proposal reflects EMA’s decision to make mitigating the threat posed by antimicrobial resistance a key strategic goal. In the proposal, which covers EMA’s plans for 2021 to 2025, the Committee for Medicinal Products for Veterinary Use (CVMP) commits to maintaining the effectiveness of existing antimicrobials and encouraging the development of new products.
CVMP also proposes to issue guidance on the development of new antimicrobials and alternative ways of tackling microbes, and provide advice on the evidence companies need to generate to benefit from the additional data protection afforded to products that reduce antimicrobial resistance.
Some of CVMP’s other proposed aims and actions overlap with those activities. For example, the agency would “provide opinions for the authorisation of effective antimicrobial veterinary medicinal products ensuring that the necessary risk management measures are applied so that products can be used safely and sustainably.”
CVMP proposes to update its guidelines in light of new definitions for words including antimicrobial and prophylaxis. CVMP also may provide guidance to clarify the “exceptional cases” when prophylactic use of antimicrobials is permitted.
The proposal also addresses the public health risks that could arise from veterinary uses of antimicrobials, supporting the responsible use of antimicrobials and recognizes that antimicrobial resistance is a global problem. In trying to achieve those goals, CVMP may develop guidance on antimicrobial use in companion animals and increase collaboration with European and international agencies.
The draft strategy is open for comment until the end of September.
Draft Strategy
EMA agrees to share confidential COVID-19 information with Korea
EMA and the Korean Ministry of Food and Drug Safety (MFDS) have agreed to share confidential information about products used in the response to the COVID-19 pandemic.
EMA has existing confidentiality arrangements with peers in countries including Australia, Canada and the US, as well as with the World Health Organization, but previously lacked a means to share such information with MFDS.
EMA and MFDS have formed an ad-hoc arrangement that only covers COVID-19. EMA enters into such ad-hoc arrangements, which have limited scope and duration, to address specific public health needs. The arrangements enable EMA to share some information without negotiating wide-reaching, permanent confidentiality agreements.
Press Release
Swissmedic to make packaging mock-ups mandatory to prevent delays
Starting 1 October, the Swiss Agency for Therapeutic Products (Swissmedic) will require manufacturers seeking approval of medicines to submit mock-ups of packaging texts with their initial application; currently, mock-ups are recommended.
Swissmedic began trying to shorten the labeling phase of the drug approval process in 2017 after a benchmarking study identified additional text review rounds as a source of delays to the authorization of new medicines. This week, Swissmedic said the actions it took in 2017 are starting to yield positive results, notably by bringing the start of the dialogue over labeling forward to the List of Questions (LoQ) phase.
Swissmedic also has committed to sending annotated mock-ups with the LoQ, regardless of whether a drug looks likely to be approved at that stage and will increasingly compose texts itself if applicants fail to meet the requirements. Two new measures are now in effect and apply to all applications that are yet to reach the LoQ stage.
Swissmedic Notice
EMA discloses spending an additional €1M on clinical trial portal
EMA has disclosed a €1 million ($1.1 million) contract modification related to the development of its delayed clinical trial portal and database.
With the portal already two years behind schedule, everis, the leader of the IT4U Consortium doing the work, took the lead on the development of the system last year. This week, EMA’s disclosure of contract changes from 2019 revealed a €1 million modification in the value of a contract it has with everis and other members of the consortium.
EMA disclosed the €1 million modification alongside news that it spent €20.4 million under the wider contract last year. Since 2016, EMA has spent €80.5 million under the contract. The original tender was for €80 million, excluding VAT.
There is still work to do to get the system operational. EMA expects to start an audit of the system in December. In the original timeline, EMA expected to go live 13 months after the start of the audit.
Contract List, More
Dutch MEB to draft list of generic drugs with interchangeability issues
The Dutch Medicines Evaluation Board (MEB) is drawing up a list of generic drugs that could have undesirable effects when used interchangeably with their reference products.
Generic medicines are often used interchangeably with their reference products as they feature the same active ingredient, dose and route of administration. However, factors such as differences in the bioavailability and administration devices of generic and branded products means moving from one medicine to another can cause problems.
Such issues have led organizations including Ireland’s Health Products Regulatory Authority to create lists of interchangeable medicines. MEB, at the request of the Ministry of Health, Welfare and Sport, has begun a similar initiative.
MEB is creating a list of products that can cause serious health problems when used interchangeably. In collaboration with groups representing patients and healthcare professionals, MEB plans to finish the list by the end of the year. MEB will then review the list annually.
MEB Statement (Dutch)
Other News:
CVMP has published a question and answer document about the management of extraneous agents in immunological veterinary medicinal products. The document covers the testing methods that can be used, the validation of new test techniques and the justification required to not test for a specific agent. CVMP Q&A
Swissmedic has issued a warning about non-conforming medical face masks. The warning follows the discovery of “an increasing number” of non-conforming masks on the Swiss market. Swissmedic is advising healthcare institutions to use established procurement channels, thoroughly scrutinize new suppliers and “ignore promotional emails from dubious sources.” Swissmedic Notice
EMA has adopted measures to avoid medication errors involving Deferasirox Mylan and leuprorelin depot. The measures are intended to prevent errors stemming from confusion with similar products and incorrect use of delivery devices. EMA proposed the leuprorelin depot measures after a review by its safety committee. Deferasirox Mylan, Leuprorelin Depot


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