Euro Roundup: EMA clarifies label flexibility for COVID vaccines
COVID-19 vaccines may be distributed in English-language only packaging in Europe under temporary measures designed to ensure speedy deployment of vaccines against the coronavirus, according to a question-and answer-document published by the European Medicines Agency (EMA).Based on principles set out in a statement from the European Commission, EMA will permit manufacturers to provide COVID-19 vaccines with outer and immediate packaging that only carries text in the English language. Since most Member States have waived the need for the printed package leaflet to be in their national language as well, QR codes may be used to provide those. EMA wants companies to include the code in the printed package leaflet or on a separate card that is given to vaccinated patients. QR codes also can be used to provide Blue Box information.
Manufacturers do not have to include the package leaflet in the outer carton due to “the logistical challenges associated with initiating printing activities at an early stage in order to facilitate the large scale and rapid deployment of the vaccine,” according to EMA. Companies that are unable to include a leaflet in the vaccine carton must distribute it alongside the product.
Abbreviated package leaflet in the outer carton are not permitted. EMA rejected the option in the belief an abbreviated leaflet is unable to convey all information essential to the safe and effective use of the vaccine.
Similarly, EMA is refusing to routinely waive the need to perform user testing on the package leaflet, despite acknowledging “difficulties in recruiting respondents due to isolation measures in different countries and short timelines.” EMA wants applicants to “make every effort using alternative methods and technologies to ensure the readability of the proposed package leaflet.” If those efforts provide inadequate, EMA will discuss “the approach to be applied” on a case by case basis.
Manufacturers that take advantage of any of the permitted flexibilities must let EMA know how long they will need to diverge from standard practices. Exemptions may be limited to a certain period or number of batches. Details regarding granted exemptions will be published on the EMA website.
EMA Q&A
MHRA posts guidance on sponsor access to EHRs in clinical trials
The move from paper to electronic helath records creates three key challenges for clinical trial data management, according to new guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The challenges include direct access by the monitor to records; ensuring access is restricted to trial participants ;and ensuring monitors are unable to access records on people not in the trial whose data is maintained in the same system, the guidance notes. Traditionally, study sites simply handed monitors physical copies of just the records they required. Digital data requires a different approach.
Some – but not all – electronic health record (EHR) systems permit restricted access, enabling sites to control who sees which records. MHRA’s guidance addresses safeguards for sites that lack the ability to provide restricted access to EHRs.
Some sites have printed out medical records for monitors to review. That approach enables sites to control access as they did during the paper era but MHRA has identified issues during inspections. The regulator said printouts sometimes lack important information, including weeks of data. The practice also burdens sites and carries General Data Protection Regulation compliance risks.
“Resorting to printouts from the EHR is not an appropriate mitigation or safeguard, ” the guidance notes. Accepted short-term options include relying upon information governance obligations imposed on sponsors by model clinical trial agreements. Monitors could be provided access to an EHR in accordance with the template agreement.
MHRA Guidance
EMA shares advice on regulation in Northern Ireland after Brexit
EMA has published guidance on how medicinal products will be regulated in Northern Ireland after the UK completes its split from the European Union at the end of the year.
Seeking to avoid a hard border between Northern Ireland and Ireland, the UK and EU agreed the Protocol on Ireland/Northern Ireland. The protocol keeps Northern Ireland subject to EU rules. EMA published a Q&A document last week to clarify what the arrangement will mean in practice.
The guidance addresses changes required in the Article 57 database, which houses information on medicines authorized in the European Economic Area, fees, pharmacovigilance and other aspects of the regulation of human and veterinary medicinal products.
EMA revised the text within days of publication, stating “it has to be borne in mind that the EMA is not participating in any of the negotiations between the Union and the UK that aim at solving – before the end of 2020 - the particular challenges that small markets face as that historically are dependent on medicines supply from or through Great Britain, notably Northern Ireland.”
The release of the Q&A comes weeks after the UK and EU agreed to give the pharmaceutical industry 12 months, starting from 1 January, to comply with the Northern Ireland regulatory requirements. Pam Cameron, a Democratic Unionist Party politician in Northern Ireland, said the agreement gives “immediate relief but is not a permanent panacea” in a debate on drug and device legislation.
EMA Q&A, Debate Transcript
UK approves regulation on supplementary protection certificates
The House of Lords has approved regulations on how supplementary protection certificates (SPCs) will work in the UK after Brexit. The approval clears the statutory instrument to be signed into law.
Currently, EU law covers a system that permits the UK to grant SPCs to provide patent holders with additional protection. Companies need a valid UK marketing authorization to get a SPC. From January onward, two types of marketing authorization will be valid in the UK due to the different regulatory situation in Northern Ireland. The statutory instrument addresses the situation.
The plan approved by the House of Lords is intended to hew closely to the current system while allowing SPCs to be granted regardless of which type of UK-applicable marketing authorization the applicant possesses.
“The purpose of the instrument is to incorporate the changes to the regulatory system into the existing SPC framework so that businesses will not have to do anything significantly different. They will file the same forms, pay the same fees and engage with the same authorities as at present,” Lord Callanan, a peer in the ruling Conservative Party, said in a debate on the topic.
Debate Transcript
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The Swiss Agency for Therapeutic Products (Swissmedic) is offering free scientific and regulatory advice on essential human medicinal products. The free service is available to companies working on the active substances listed in a Swiss text on essential medicines. Swissmedic will clarify regulatory issues regarding the authorization of the active substances “efficiently and free of charge.” The agency said the service is intended to counter possible supply shortfalls. Swissmedic Notice